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Negative pressure wound therapy for managing the open abdomen

in non-trauma patients (Review)

Cheng Y, Wang K, Gong J, Liu Z, Gong J, Zeng Z, Wang X

Cheng Y, Wang K, Gong J, Liu Z, Gong J, Zeng Z, Wang X.

Negative pressure wound therapy for managing the open abdomen in non-trauma patients.
Cochrane Database of Systematic Reviews 2022, Issue 5. Art. No.: CD013710.
DOI: 10.1002/14651858.CD013710.pub2.

www.cochranelibrary.com

Negative pressure wound therapy for managing the open abdomen in non-trauma patients (Review)
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TABLE OF CONTENTS
ABSTRACT..................................................................................................................................................................................................... 1
PLAIN LANGUAGE SUMMARY....................................................................................................................................................................... 2
SUMMARY OF FINDINGS.............................................................................................................................................................................. 4
BACKGROUND.............................................................................................................................................................................................. 7
OBJECTIVES.................................................................................................................................................................................................. 8
METHODS..................................................................................................................................................................................................... 8
RESULTS........................................................................................................................................................................................................ 12
Figure 1.................................................................................................................................................................................................. 13
Figure 2.................................................................................................................................................................................................. 14
Figure 3.................................................................................................................................................................................................. 15
DISCUSSION.................................................................................................................................................................................................. 17
AUTHORS' CONCLUSIONS........................................................................................................................................................................... 18
ACKNOWLEDGEMENTS................................................................................................................................................................................ 18
REFERENCES................................................................................................................................................................................................ 19
CHARACTERISTICS OF STUDIES.................................................................................................................................................................. 23
DATA AND ANALYSES.................................................................................................................................................................................... 28
Analysis 1.1. Comparison 1: NPWT versus Bogota bag, Outcome 1: Time to primary fascial closure of the abdomen................... 28
Analysis 1.2. Comparison 1: NPWT versus Bogota bag, Outcome 2: Adverse events........................................................................ 29
Analysis 1.3. Comparison 1: NPWT versus Bogota bag, Outcome 3: All-cause mortality.................................................................. 29
Analysis 1.4. Comparison 1: NPWT versus Bogota bag, Outcome 4: Length of hospital stay........................................................... 29
Analysis 2.1. Comparison 2: Suprasorb CNP system versus ABThera system, Outcome 1: Proportion of participants with 30
successful primary fascial closure of the abdomen...........................................................................................................................
Analysis 2.2. Comparison 2: Suprasorb CNP system versus ABThera system, Outcome 2: Adverse events..................................... 30
Analysis 2.3. Comparison 2: Suprasorb CNP system versus ABThera system, Outcome 3: All-cause mortality............................... 30
Analysis 2.4. Comparison 2: Suprasorb CNP system versus ABThera system, Outcome 4: Reoperation rate.................................. 30
APPENDICES................................................................................................................................................................................................. 31
HISTORY........................................................................................................................................................................................................ 38
CONTRIBUTIONS OF AUTHORS................................................................................................................................................................... 38
DECLARATIONS OF INTEREST..................................................................................................................................................................... 38
SOURCES OF SUPPORT............................................................................................................................................................................... 39
DIFFERENCES BETWEEN PROTOCOL AND REVIEW.................................................................................................................................... 39
INDEX TERMS............................................................................................................................................................................................... 39

Negative pressure wound therapy for managing the open abdomen in non-trauma patients (Review) i
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[Intervention Review]

Negative pressure wound therapy for managing the open abdomen in

non-trauma patients

Yao Cheng1, Ke Wang1, Junhua Gong2, Zuojin Liu1, Jianping Gong1, Zhong Zeng2, Xiaomei Wang1

1Department of Hepatobiliary Surgery, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China. 2Organ
Transplant Center, First Affiliated Hospital of Kunming Medical University, Kunming, China

Contact: Xiaomei Wang, [email protected].

Editorial group: Cochrane Wounds Group.

Publication status and date: New, published in Issue 5, 2022.

Citation: Cheng Y, Wang K, Gong J, Liu Z, Gong J, Zeng Z, Wang X.Negative pressure wound therapy for managing the
open abdomen in non-trauma patients. Cochrane Database of Systematic Reviews 2022, Issue 5. Art. No.: CD013710. DOI:
10.1002/14651858.CD013710.pub2.

Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT

Background
Management of the open abdomen is a considerable burden for patients and healthcare professionals. Various temporary abdominal
closure techniques have been suggested for managing the open abdomen. In recent years, negative pressure wound therapy (NPWT) has
been used in some centres for the treatment of non-trauma patients with an open abdomen; however, its effectiveness is uncertain.

Objectives
To assess the effects of negative pressure wound therapy (NPWT) on primary fascial closure for managing the open abdomen in non-trauma
patients in any care setting.

Search methods
In October 2021 we searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL EBSCO Plus. To identify
additional studies, we also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant
included studies as well as reviews, meta-analyses, and health technology reports. There were no restrictions with respect to language,
date of publication, or study setting.

Selection criteria
We included all randomised controlled trials (RCTs) that compared NPWT with any other type of temporary abdominal closure (e.g. Bogota
bag, Wittmann patch) in non-trauma patients with open abdomen in any care setting. We also included RCTs that compared different types
of NPWT systems for managing the open abdomen in non-trauma patients.

Data collection and analysis

Two review authors independently performed the study selection process, risk of bias assessment, data extraction, and GRADE assessment
of the certainty of evidence.

Main results
We included two studies, involving 74 adults with open abdomen associated with various conditions, predominantly severe peritonitis (N
= 55). The mean age of the participants was 52.8 years; the mean proportion of women was 39.2%. Both RCTs were carried out in single
centres and were at high risk of bias.

Negative pressure wound therapy versus Bogota bag

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We included one study (40 participants) comparing NPWT with Bogota bag. We are uncertain whether NPWT reduces time to primary fascial
closure of the abdomen (NPWT: 16.9 days versus Bogota bag: 20.5 days (mean difference (MD) -3.60 days, 95% confidence interval (CI) -8.16
to 0.96); very low-certainty evidence) or adverse events (fistulae formation, NPWT: 10% versus Bogota: 5% (risk ratio (RR) 2.00, 95% CI 0.20
to 20.33); very low-certainty evidence) compared with the Bogota bag. We are also uncertain whether NPWT reduces all-cause mortality
(NPWT: 25% versus Bogota bag: 35% (RR 0.71, 95% CI 0.27 to 1.88); very low-certainty evidence) or length of hospital stay compared with the
Bogota bag (NPWT mean: 28.5 days versus Bogota bag mean: 27.4 days (MD 1.10 days, 95% CI -13.39 to 15.59); very low-certainty evidence).
The study did not report the proportion of participants with successful primary fascial closure of the abdomen, participant health-related
quality of life, reoperation rate, wound infection, or pain.

Negative pressure wound therapy versus any other type of temporary abdominal closure

There were no randomised controlled trials comparing NPWT with any other type of temporary abdominal closure.

Comparison of different negative pressure wound therapy devices

We included one study (34 participants) comparing different types of NPWT systems (Suprasorb CNP system versus ABThera system).
We are uncertain whether the Suprasorb CNP system increases the proportion of participants with successful primary fascial closure of
the abdomen compared with the ABThera system (Suprasorb CNP system: 88.2% versus ABThera system: 70.6% (RR 0.80, 95% CI 0.56 to
1.14); very low-certainty evidence). We are also uncertain whether the Suprasorb CNP system reduces adverse events (fistulae formation,
Suprasorb CNP system: 0% versus ABThera system: 23.5% (RR 0.11, 95% CI 0.01 to 1.92); very low-certainty evidence), all-cause mortality
(Suprasorb CNP system: 5.9% versus ABThera system: 17.6% (RR 0.33, 95% CI 0.04 to 2.89); very low-certainty evidence), or reoperation
rate compared with the ABThera system (Suprasorb CNP system: 100% versus ABThera system: 100% (RR 1.00, 95% CI 0.90 to 1.12); very
low-certainty evidence). The study did not report the time to primary fascial closure of the abdomen, participant health-related quality of
life, length of hospital stay, wound infection, or pain.

Authors' conclusions
Based on the available trial data, we are uncertain whether NPWT has any benefit in primary fascial closure of the abdomen, adverse
events (fistulae formation), all-cause mortality, or length of hospital stay compared with the Bogota bag. We are also uncertain whether
the Suprasorb CNP system has any benefit in primary fascial closure of the abdomen, adverse events, all-cause mortality, or reoperation
rate compared with the ABThera system. Further research evaluating these outcomes as well as participant health-related quality of life,
wound infection, and pain outcomes is required. We will update this review when data from the large studies that are currently ongoing
are available.

PLAIN LANGUAGE SUMMARY

What are the benefits and risks of negative pressure wound therapy for managing the open abdomen in people who are not trauma
patients?

Key messages

- We do not know if negative pressure wound therapy (NPWT, defined as pressure lower than a given reference pressure, generally causing
suction) helps abdominal wounds to heal quicker or reduces potential harmful effects compared with using a Bogota bag (a sterilised fluid
bag used for closing abdominal wounds).

- We do not know if a Suprasorb CNP system (a type of NPWT) helps abdominal wounds to heal quicker or reduces potential harmful effects
compared with using an ABThera system (another type of NPWT).

- We do not know if NPWT increases the risk of bowel perforation. Future research should explore healing time, potential unwanted or
harmful effects, all-cause mortality, length of hospital stay, health-related quality of life, reoperation rate, wound infection, and pain
outcomes.

What is an open abdomen?

Sometimes a person's abdomen needs to be left open while it heals after surgery. However, high death rates are associated with leaving
the abdomen open after surgery. Managing the open abdomen is a considerable burden for patients and doctors.

How is this managed?

NPWT uses a sealed dressing connected to a vacuum pump to drain fluid from a wound. However, the safety and effectiveness of NPWT
as a treatment for open abdomen is still uncertain.

NPWT has been used in recent years to treat non-trauma patients after abdominal surgery. Non-trauma patients are people who need
surgery for conditions that are not caused by trauma (e.g. abdominal infection, cancer, ischaemia).

What did we want to find out?

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We wanted to find out whether NPWT is effective in treating the open abdomen after surgery in non-trauma patients in any care setting.
We wanted to compare NPWT with other treatment methods or other types of NPWT, and we were particularly interested in their effects
on the following:

- wound closure (how long it took for wounds to close and how many people had wounds that fully closed);

- if there were any harmful or unwanted effects (e.g. bowel perforation);

- death rate;

- participant health-related quality of life or health status;

- length of hospital stay;

- reoperation rate;

- wound infection; and

- pain.

What did we do?

We searched for studies that compared NPWT with any other type of temporary abdominal closure in non-trauma patients with open
abdomen. We also included studies that compared different types of NPWT systems for managing the open abdomen in non-trauma
patients. We had no restrictions with respect to language, date of publication, or where the study was conducted. We rated our confidence
in the evidence, based on factors such as study methods and sizes.

What did we find?

We found one single-centre study conducted in Turkey, which included 40 adults with open abdomen. Participants were randomly
allocated to treatment with either NPWT or a Bogota bag. We cannot tell from the results whether when compared to Bogota bag, NPWT
reduces:

- the time needed for wounds to completely close;

- harmful or unwanted effects (bowel perforation);

- death rate; or

- length of hospital stay between the groups.

The study did not report the proportion of people with wounds that were successfully closed, participant health-related quality of life,
reoperation rate, wound infection, or pain.

We found another single-centre study, which was conducted in Austria and included 34 adults with open abdomen. Participants were
randomly allocated to treatment with either a Suprasorb CNP system or an ABThera system. We cannot tell from the results whether when
compared to an ABThera system, a Suprasorb CNP system reduces:

- the proportion of people with wounds that were successfully closed;

- harmful or unwanted effects (bowel perforation);

- death rate; or

- reoperation rate between the groups.

The study did not report the time needed for wounds to completely close, participant health-related quality of life, length of hospital stay,
wound infection, or pain.

What are the limitations of the evidence?

We only found two relevant studies, so we are uncertain about the benefits or harms of using NPWT compared with using a Bogota bag or
different types of NPWT systems. We did not find any studies that compared NPWT with other types of temporary abdominal closure.

How up to date is this evidence?

The evidence is up to date to October 2021.

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Negative pressure wound therapy for managing the open abdomen in non-trauma patients (Review)
SUMMARY OF FINDINGS

Summary of findings 1. NPWT compared with the Bogota bag for managing the open abdomen in non-trauma patients

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NPWT compared with the Bogota bag for managing the open abdomen in non-trauma patients

Patient or population: adults with an open abdomen after surgery who have not experienced trauma
Setting: hospital
Intervention: NPWT

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Comparison: Bogota bag

Outcomes Anticipated absolute effects* (95% Relative effect Number of par- Certainty of Comments
CI) (95% CI) ticipants the evidence
(studies) (GRADE)
Risk with Bo- Risk with NPWT
gota bag

Time to primary fascial closure The mean time The mean time MD 3.6 days 40 ⊕⊝⊝⊝ Uncertain evidence on the effect
of the abdomen to primary fas- to primary fascial lower (1 study) Very low1 of NPWT on time to primary fas-
cial closure of closure of the ab- (8.16 lower to cial closure of the abdomen com-
Follow-up: 60 days the abdomen domen was 16.9 0.96 higher) pared with the Bogota bag
was 20.5 days. days.

Proportion of participants with Not reported

successful primary fascial clo-
sure of the abdomen

Follow-up: 60 days

Adverse events (fistulae forma- Study population RR 2.00 40 ⊕⊝⊝⊝ Uncertain evidence on the effect
tion) (0.20 to 20.33) (1 study) Very low2 of NPWT on adverse events (fistu-
50 per 1000 100 per 1000 lae formation) compared with the

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Follow-up: 60 days (10 to 1000) Bogota bag

All-cause mortality Study population RR 0.71 40 ⊕⊝⊝⊝ Uncertain evidence on effect of

(0.27 to 1.88) (1 study) Very Low3 NPWT on all-cause mortality com-
Follow-up: 60 days 350 per 1000 248 per 1000 pared with the Bogota bag
(95 to 658)

Participant health-related quali- Not reported

ty of life

Follow-up: 60 days
4
Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Negative pressure wound therapy for managing the open abdomen in non-trauma patients (Review)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and
its 95% CI).
CI: Confidence interval; RR: Risk ratio; MD: Mean difference; NPWT: Negative pressure wound therapy.

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GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is
substantially different.
Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect.

Better health.
Informed decisions.
Trusted evidence.
Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect.

1We downgraded the evidence twice for very serious risk of bias in the domains of random sequence generation, allocation concealment, and blinding of outcome assessment;
once for serious indirectness (33 non-trauma patients and 7 trauma patients); and twice for very serious imprecision due to small sample size and wide confidence intervals.
2We downgraded the evidence twice for very serious risk of bias in the domains of random sequence generation, allocation concealment, and blinding of outcome assessment;
once for serious indirectness (33 non-trauma patients and 7 trauma patients); and twice for very serious imprecision because of small sample size and wide confidence intervals.
3We downgraded the evidence once for serious indirectness (33 non-trauma patients and 7 trauma patients) and twice for very serious imprecision because of small sample size
and wide confidence intervals. We did not downgrade for risk of bias because we considered this an objective outcome, which is unlikely to be affected by performance bias
and detection bias.

Summary of findings 2. Suprasorb CNP system compared with the ABThera system for managing the open abdomen in non-trauma patients

Suprasorb CNP system compared with the ABThera system for managing the open abdomen in non-trauma patients

Patient or population: adults with an open abdomen after surgery who have not experienced trauma
Setting: hospital
Intervention: Suprasorb CNP system
Comparison: ABThera system

Outcomes Anticipated absolute effects* Relative effect Number of par- Certainty of Comments
(95% CI) (95% CI) ticipants the evidence
(studies) (GRADE)

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Risk with Risk with
ABThera sys- Suprasorb CNP
tem system

Time to primary fascial clo- Not reported

sure of the abdomen

Follow-up: 60 days

Proportion of participants Study population RR 0.80 34 ⊕⊝⊝⊝ Uncertain evidence on effect of the
with successful primary fas- (0.56 to 1.14) (1 study) Very low1 Suprasorb CNP system on proportion of
cial closure of the abdomen 882 per 1000 706 per 1000 participants with successful primary fas-
5
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Negative pressure wound therapy for managing the open abdomen in non-trauma patients (Review)
Follow-up: 60 days (494 to 1000) cial closure of the abdomen compared
with the ABThera system

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Adverse events Study population RR 0.11 34 ⊕⊝⊝⊝ Uncertain evidence on the effect of
(0.01 to 1.92) (1 study) Very low2 the Suprasorb CNP system on adverse
(fistulae formation) 235 per 1000 26 per 1000 events (fistulae formation) compared
(2 to 452) with the ABThera system
Follow-up: 60 days

All-cause mortality Study population RR 0.33 34 ⊕⊝⊝⊝ Uncertain evidence on the effect of the

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Trusted evidence.
(0.04 to 2.89) (1 study) Very low3 Suprasorb CNP system on all-cause
Follow-up: 60 days 176 per 1000 58 per 1000 mortality compared with the ABThera
(7 to 510) system

Participant health-related Not reported

quality of life

Follow-up: 60 days

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and
its 95% CI).
CI: Confidence interval; RR: Risk ratio; MD: Mean difference.

GRADE Working Group grades of evidence

High certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is
substantially different.
Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

1We downgraded the evidence twice for very serious risk of bias in the domains of blinding of outcome assessment and other potential sources of bias, once for serious indirectness
(31 non-trauma patients and 3 trauma patients), and twice for very serious imprecision because of small sample size and wide confidence intervals.
2We downgraded the evidence twice for very serious risk of bias in the domains of blinding of outcome assessment and other potential sources of bias, once for serious indirectness

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(31 non-trauma patients and 3 trauma patients), and twice for very serious imprecision because of small sample size and wide confidence intervals.
3We downgraded the evidence once for serious risk of bias in the domain of other potential sources of bias, once for serious indirectness (31 non-trauma patients and 3 trauma
patients), and twice for very serious imprecision because of small sample size and wide confidence intervals. We did not downgrade for lack of blinding because we considered
this an objective outcome, which is unlikely to be affected by performance bias and detection bias.
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BACKGROUND the abdominal contents to expand; the Wittmann patch, which

involves the use of two opposing sheets sutured to the lateral
Description of the condition fascia (a sheet of connective tissue situated at or on the side) to
facilitate reoperation; sterilised zipper; and synthetic mesh (Chiara
About 143 million surgical procedures are performed worldwide
2016; Cuesta 1991; Demetriades 2014; Kreis 2013; Poortmans 2020;
each year to save lives and prevent disability (Meara 2015).
Quyn 2012; Wittmann 1993). Each technique has advantages and
Although the exact number of abdominal operations performed
disadvantages, but the ultimate goal is to achieve primary fascial
annually worldwide is unknown, about 1,313,000 abdominal
closure (full fascia-to-fascia closure and complete wound closure)
operations are performed each year in the UK, 6.1 million in
(Atema 2015; Cristaudo 2017b; Demetriades 2014; Quyn 2012).
the USA, 478,000 in Japan, and 1 million in France (Carney
2017; Fingerhut 1998; Miyata 2018; NHS Digital 2018). After these In recent years, negative pressure wound therapy (NPWT) has
operations, the abdominal walls in some people may be left open been introduced as an alternative for the treatment of critically
because of the risk of intra-abdominal hypertension (pressure) ill people with an open abdomen (Bruhin 2014; Carlson 2013;
(Cirocchi 2013; Fitzpatrick 2017; Friese 2012). Demetriades 2014; Hofmann 2017). NPWT is a device that uses a
vacuum dressing and suction pump (negative pressure) to promote
Leaving the abdomen open allows the abdominal contents
wound management and healing (Chiara 2016; Demetriades 2014;
to expand in order to reduce intra-abdominal pressure and
Dumville 2014; Dumville 2015; Kreis 2013; Liu 2018; Norman 2020;
related complications (Beckman 2016; Fitzpatrick 2017). Although
Rogers 2018). Several different commercial and non-commercial
the reasons for leaving the abdomen open vary in different
products are available for NPWT (Bruhin 2014; Dumville 2014;
geographical regions, the two most common indications are
Dumville 2015; Liu 2018; Norman 2020). The most commonly
management of severe peritonitis (abdominal infection) and
used NPWT systems are the Barker vacuum pack, the vacuum-
damage control surgery (a form of surgery typically performed by
assisted closure (V.A.C., KCI, San Antonio, TX), the ABThera system
trauma surgeons in case of severe unstable injuries) for abdominal
(Abdomen Negative Pressure Therapy System, KCI, San Antonio,
trauma (Atema 2015; Coccolini 2017a; Fernández 2016; Hofmann
TX), and the Suprasorb CNP system (Lohmann & Rauscher, United
2017; Sartelli 2015). People with an open abdomen are often
Arab Emirates) (Auer 2021; Demetriades 2014; Fitzpatrick 2017;
critically ill and require treatment in the intensive care unit (Acosta
Montori 2017; Norman 2020). The cost of commercial NPWT
2017; Beckman 2016).
systems varies but is relatively high. For example, each ABThera
Management of the open abdomen is a considerable burden device costs approximately USD 350 in the USA (Frazee 2013). It
for patients and healthcare professionals, and having an open is estimated that Medicare payments for NPWT systems increased
abdomen is associated with high mortality (Acosta 2017; Beckman from USD 24 million to USD 164 million (an increase of almost 583%)
2016; Hofmann 2017; Seternes 2017). The reported mortality rate in the USA between 2001 and 2007 (HHS 2009).
ranges from 21% to 55% in different studies (Acosta 2017; Fortelny
2014; Hofmann 2017; Rausei 2018). The main cause of death in
How the intervention might work
these patients is multiple organ dysfunction syndrome (Boele van NPWT use for the management of open abdomen wounds involves
Hensbroek 2016; Mayr 2006). Having an open abdomen may also a porous dressing that covers the abdominal contents, with a
be associated with serious complications, such as severe fluid membrane between the dressing and the abdominal contents
and heat loss, bowel fistulae formation (an opening connecting (NICE 2013). Another perforated adhesive membrane is used to
the bowel to the body surface or to another hollow organ), loss cover the entire wound and surrounding skin, and this is attached
of abdominal wall domain, and development of incisional hernia to a suction system with a drainage tube (Liu 2018; Dumville 2014;
(the abnormal exit of tissue or an organ through the wall of Dumville 2015; NICE 2013; Norman 2020). The suction system,
the cavity caused by an incompletely healed surgical wound) using negative pressure, removes fluid and infectious materials
(Beckman 2016; Chiara 2016; Demetriades 2014). The best way to from the open abdomen (KCI Medical 2020). NPWT may potentially
prevent or reduce these complications is to close the abdomen facilitate wound healing and management of the open abdomen by
as soon as possible (Chiara 2016; Cristaudo 2017a; Demetriades several different mechanisms. First, the porous dressing may help
2014; Hofmann 2017). If abdominal closure is not possible, one to isolate the abdominal contents from the abdominal wall and
effective method is to close the abdominal wall temporarily (Chiara external environment. Second, the negative pressure may actively
2016; Cristaudo 2017a; Demetriades 2014). The ideal method of remove fluid, help to reduce oedema (an excessive accumulation of
temporary abdominal closure should protect abdominal contents, fluid in the spaces within the tissue), and prevent intra-abdominal
prevent further contamination and intra-abdominal hypertension, hypertension. Third, the pressure effect is proposed to promote
remove any infected fluid, limit infection, facilitate reoperation, cellular migration and growth of new blood vessels. Finally, it
preserve abdominal wall tissue, avoid fascial edge retraction, may provide medial tension, which may help to minimise fascial
facilitate nursing care, and promote successful abdominal closure. retraction and facilitate the achievement of primary closure (NICE
The method should also be inexpensive and cost-effective (Chiara 2013).
2016; Cristaudo 2017b; Demetriades 2014; Kreis 2013; Rogers 2018).
Why it is important to do this review
Description of the intervention
The use of NPWT for managing the open abdomen is controversial
Various temporary abdominal closure techniques have been (Atema 2015; Coccolini 2017b; Coccolini 2018; Sartelli 2015). NPWT
suggested for managing the open abdomen, such as the Bogota may potentially benefit people in terms of reduced mortality and
bag, which is a sterilised intravenous fluid bag sutured to the successful primary fascial closure; conversely, it may have no
fascia (a sheet of connective tissue covering, supporting, or benefits and could even lead to adverse effects, such as increasing
binding together internal organs or parts of the body) to allow the risk of bowel fistulae formation (Carlson 2013; Giudicelli

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2017; Hofmann 2017). The National Institute for Health and Care Types of outcome measures
Excellence (NICE) in the UK published guidance about NPWT for
We list primary and secondary outcomes below. If a study
the open abdomen in 2013 (NICE 2013). NICE concluded that
was otherwise eligible (e.g. correct study design, population,
evidence was adequate to support the use of NPWT for the open
intervention, and comparator) but did not report a listed outcome,
abdomen, but also encouraged more research on this issue (NICE
we contacted the study authors when possible to establish whether
2013). One Cochrane Review has assessed the role of NPWT in
an outcome of interest was measured but not reported. If the study
open traumatic wounds (Iheozor-Ejiofor 2018). The protocol for
authors had replied and stated that none of the outcomes were
our review was originally published in 2016 (Boele van Hensbroek
measured in their study, we would have included the study and
2016); we published a new version in 2020 (Cheng 2020). The aim of
discussed the potential of selective outcome reporting.
our review is to inform decision makers and guide future research.
We reported outcome measures at the latest time point available
OBJECTIVES (assumed to be the length of follow-up if not specified) and the time
To assess the effects of negative pressure wound therapy (NPWT) point specified in the study methods as being of primary interest
on primary fascial closure for managing the open abdomen in non- (if this was different from the latest time point available). If data
trauma patients in any care setting. had allowed, we would have used the latest time point available
for the primary analysis and used the time point specified in the
METHODS methods as being of primary interest as a sensitivity analysis. For
all outcomes, we classed assessment of outcome measures from:
Criteria for considering studies for this review
• less than one week to eight weeks as short term;
Types of studies • greater than eight weeks to 26 weeks as medium term; and
Eligible studies were randomised controlled trials (RCTs), including • greater than 26 weeks as long term.
cluster RCTs. We intended to include studies reported as full text
or published as abstract only, as well as unpublished data. We Primary outcomes
excluded cross-over trials as they are not an appropriate design • Primary fascial closure of the abdomen
in this context. We excluded quasi-randomised trials and non-
• Adverse events
randomised studies.
Primary fascial closure
Types of participants
We defined primary fascial closure as full fascia-to-fascia closure
Eligible trials were those involving adults managed in any care and complete wound closure after open abdominal treatment
setting that used NPWT for the management of the open abdomen during index admission (hospital admission during which open
that was not caused by trauma. Trials involving both trauma and abdominal treatment was started). We also accepted authors'
non-trauma patients were eligible only if the results for non- definitions of primary fascial closure. For this review, we regarded
trauma patients were presented separately and randomisation the following as providing the most relevant and rigorous measures
was stratified by trauma and non-trauma, or if 75% or more of of outcome:
the participants in the trial were non-trauma patients. We would
have excluded people who underwent abdominal wall correction • time to primary fascial closure of the abdomen (we recorded
months or years after initial management of the open abdomen whether or not censored data had been appropriately analysed
because in these cases the open abdomen is not treated during the and listed any adjustment factors); and
first admission. Trials recruiting participants at first and subsequent • proportion of participants with successful primary fascial
hospital admissions were eligible only if the results for the first closure of the abdomen (frequency of primary fascial closure) at
admission were presented separately and randomisation was a particular time point.
stratified by first and subsequent treatments, or if 75% or more of
the participants in the trial were first-admission patients. If both of the outcomes above had been reported, we would have
presented all data in a summary outcome table for reference,
Types of interventions but focused on reporting time to primary fascial closure. We
The primary intervention was NPWT delivered by any mode. We accepted the authors' definitions of what constituted primary
planned to assess the following comparisons for people with an fascial closure. Time to primary fascial closure was our preferred
open abdomen not caused by trauma: measure; however, we did not expect it to be reported in many
studies.
• NPWT (both commercial and non-commercial products) versus
an alternative method of temporary abdominal closure (e.g. Adverse events
Bogota bag, Wittmann patch, sterilised zipper, or synthetic Adverse events where a clear methodology for the collection
mesh); and of adverse event data was provided. These included fistulae
• one type of NPWT system versus a different type of NPWT formation, hernia formation, intra-abdominal abscess, and failure
system. to maintain negative pressure. We reported the number of
participants in each group with an event.
We only included RCTs in which the use of a specific NPWT
intervention during the treatment period was the only systematic Secondary outcomes
difference between treatment groups.
• All-cause mortality

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• Participant health-related quality of life or health status Searching other resources

(measured using a standardised generic questionnaire such as
Searching reference lists of included trials and relevant reviews
EuroQol-5D (EQ-5D); 36-item, 12-item, or 6-item Short Form
(SF-36, SF-12, or SF-6); or wound-specific questionnaires such as We identified other potentially eligible trials or ancillary
the Cardiff Wound Impact Schedule (CWIS)). We did not include publications by searching the reference lists of retrieved included
ad hoc measures of quality of life that were not likely to be trials as well as relevant systematic reviews, meta-analyses, and
validated and would not be common to multiple trials. health technology assessment reports.
• Length of hospital stay
Searching by contacting individuals or organisations
• Reoperation rate
• Wound infection: as defined by study authors (number of When necessary, we contacted authors of key papers and abstracts
participants in each group with wound infection) to request further information about their trials.
• Pain (measured using survey or questionnaire or data capture Adverse effects
process or visual analogue scale)
We did not perform a separate search for adverse effects of
Search methods for identification of studies interventions used; we only considered adverse effects described
in included studies.
Electronic searches
We searched the following electronic databases to identify reports Data collection and analysis
of relevant clinical trials: Selection of studies
• Cochrane Wounds Specialised Register (searched 4 October Two review authors (KW, JG) independently assessed the titles and
2021); abstracts of the citations retrieved by the searches for relevance.
• Cochrane Central Register of Controlled Trials (CENTRAL) in the After this initial assessment, we obtained full-text copies of all
Cochrane Library searched via the Cochrane Register of Studies studies that we considered to be potentially relevant. Two review
(searched 4 October 2021); authors (KW, JG) independently checked the full papers for
• MEDLINE Ovid including In-Process & Other Non-Indexed eligibility; disagreements were resolved by discussion and, where
Citations (1946 to 4 October 2021); required, the input of a third review author (XW). Where required
and possible, we contacted study authors where the eligibility
• Embase Ovid (1974 to 4 October 2021); and
of a study was unclear. We recorded all reasons for exclusion of
• CINAHL EBSCO Plus (Cumulative Index to Nursing and Allied studies for which we had obtained full copies in the 'Characteristics
Health Literature; 1937 to 4 October 2021). of excluded studies' tables. We completed a PRISMA flowchart to
We provide the search strategies for the Cochrane Wounds summarise this process (Liberati 2009).
Specialised Register, CENTRAL, MEDLINE Ovid, Embase Ovid, If studies had been reported in multiple publications or reports, we
and CINAHL EBSCO Plus in Appendix 1. In MEDLINE Ovid, would have obtained all publications and collated the reports so
we combined the subject-specific strategy with the sensitivity- that each study, rather than each report, was the unit of interest
maximising version of the Cochrane highly sensitive search strategy for the review, and the study had a single identifier with multiple
for identifying randomised trials (2008 revision) (Lefebvre 2021). references. We would have extracted data from all reports to ensure
We combined the Embase Ovid search with the Embase Ovid that maximal relevant data were obtained.
filter developed by Cochrane UK (Lefebvre 2021). We combined
the CINAHL EBSCO Plus search with the trial filter developed Data extraction and management
by Glanville 2019. There were no restrictions with respect to
language, date of publication, or study setting. We extracted and summarised details of the eligible studies using
a data extraction sheet. Two review authors (ZL, JG) independently
We also searched the following clinical trials registries: extracted data, resolved disagreements by discussion, and drew
on a third review author (XW) where required. Where data were
• US National Institutes of Health Ongoing Trials Register missing from reports, we attempted to contact the study authors to
ClinicalTrials.gov (www.clinicaltrials.gov; searched 4 October obtain this information. Where we included a study with more than
2021); and two intervention arms, we only extracted data from intervention
• World Health Organization International Clinical and control groups that met the eligibility criteria. If we had
Trials Registry Platform (www.who.int/clinical-trials-registry- included a study with more than two eligible intervention arms, to
platform; searched 4 October 2021). avoid double-counting of participants, we would have used either
separate comparisons (with different forest plots) or combined
In addition, we carried out a separate, more sensitive search intervention groups where we considered this appropriate.
designed specifically to identify trial registry records:
We extracted the following data where possible by treatment group
• Cochrane Central Register of Controlled Trials (CENTRAL) in the for the prespecified interventions and outcomes in this review
Cochrane Library via the Cochrane Register of Studies (searched and completed a 'Characteristics of included studies' table. We
4 October 2021). collected the following outcome data for relevant time points as
described in Types of outcome measures:
We provide the search strategies for clinical trial registries
in Appendix 1. • country of origin;

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• type of surgery; time to primary fascial closure) as hazard ratios (HRs) and 95% CIs
• trial design (e.g. parallel, cluster); where possible, in accordance with the methods described in the
• care setting; Cochrane Handbook for Systematic Reviews of Interventions (Deeks
2021). If studies reporting time-to-event data (e.g. time to primary
• number of participants randomised to each trial arm;
fascial closure) did not report an HR, then where feasible, we would
• eligibility criteria and key baseline participant data; have estimated this using other reported outcomes, such as the
• size of the wound; numbers of events, through the application of available statistical
• details of treatment regimen received by each group; methods (Parmar 1998).
• duration of treatment;
Unit of analysis issues
• details of any co-interventions;
• primary and secondary outcome(s) (with definitions); We expected that the unit of analysis in most trials was
one participant with one abdominal wound subjected to one
• outcome data for primary and secondary outcomes (by group);
intervention. For such trials, we treated the participant as the
• duration of follow-up; unit of analysis when the number of abdominal wounds assessed
• number of withdrawals (by group); appeared equal to the number of participants (e.g. abdominal
• publication status of study; and wound per participant). However, we had anticipated that there
• source of funding for trial. might have been trials that presented the following two types of
unit of analysis issues.
Assessment of risk of bias in included studies
Participants could have had multiple wounds that were all
Two review authors (YC, ZZ) independently assessed the included randomised to the same intervention (where all of their abdominal
studies using Cochrane's RoB 1 tool (Higgins 2017). This tool wounds received this intervention), and if the analyses focused on
addresses six specific domains: sequence generation, allocation the wound, this would be clustered data (wounds clustered on an
concealment, blinding, incomplete data, selective outcome individual). We would have recorded where a cluster RCT had been
reporting, and other sources of bias. We assessed blinding and conducted or where a trial contained evidence of clustered data.
completeness of outcome data for each of the review outcomes We would have noted cases of incorrect analyses. We would have
separately. We noted that since primary fascial closure was a recorded this as part of the risk of bias assessment. If possible, we
subjective outcome, it was at high risk of measurement bias when would have approximated the correct analyses based on guidance
outcome assessment was not blinded. We present our assessment in the Cochrane Handbook (Higgins 2021b), using the following
of risk of bias using two risk of bias summary figures: a summary information:
of bias for each item across all studies and a summary of bias for
each trial across all of the risk of bias items. If we judged a trial • the number of clusters (or groups) randomised to each
to be at low risk of bias in all domains, we considered it to be at intervention group or the mean size of each cluster;
low risk of bias overall. We considered trials to be at high risk of • the outcome data ignoring the cluster design for the
bias if we judged them to be at high risk of bias for one or more total number of participants (e.g. number or proportion of
domains, or if we judged the risk of selection bias or performance participants with events or means and standard deviations); and
and detection bias to be unclear. If we had included trials that • an estimate of the intracluster (or intraclass) correlation
used cluster randomisation, we would also have considered the coefficient (ICC).
risk of bias in terms of recruitment bias, baseline imbalance, loss
of clusters, incorrect analysis, and comparability with individually If we could not analyse the trial data correctly, we would have
randomised trials (Higgins 2021a). We would have recorded issues extracted and presented outcome data but not analysed them
with unit of analysis, for example, where a cluster trial had been further.
undertaken but analysed at the individual level in the study report
(Appendix 2). A second alternative scenario could have been trials where
individuals had multiple abdominal wounds and abdominal
Assessment of bias in conducting the systematic review wounds were randomised to different interventions. If this had
We conducted the review according to our published been the case, we would have noted that randomisation had been
protocol, Cheng 2020, and reported any deviations from it undertaken at the abdominal wound level and assessed whether
in Differences between protocol and review. correct paired analysis was performed. If an incorrect analysis was
performed and the required data could be accessed by contacting
Measures of treatment effect the study authors, we would have tried to approximate a correct
analysis. If this was not possible, we would have extracted and
For dichotomous outcomes, we calculated the risk ratio (RR) presented the relevant outcome data but not analysed or pooled
with 95% confidence intervals (CIs). For continuously distributed them further (Lesaffre 2009).
outcome data, we used the mean difference (MD) with 95% CIs
if all trials used the same scale or similar assessment scales. Dealing with missing data
If trials had used different assessment scales, we would have
used the standardised mean difference (SMD) with 95% CIs. We It is common for data to be missing from trial reports. Excluding
considered the mean time to primary fascial closure without participants postrandomisation from the analysis or ignoring
survival analysis as a valid outcome because trial authors regarded those participants who are lost to follow-up compromises the
time to primary fascial closure as a continuous measure (as there randomisation, and potentially introduces bias into the trial. Where
was no censoring). We would have reported time-to-event data (e.g. there were missing data that we considered should be included in

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the analyses, we contacted the study authors to request whether We were unable to prespecify the amount of clinical,
these data were available. methodological, and statistical heterogeneity in the included
studies, but it might have been extensive. Thus, we anticipated
If data had remained missing for our outcome 'proportion using a random-effects approach for meta-analysis. Conducting
of participants with successful primary fascial closure of the meta-analysis with a fixed-effect model in the presence of even
abdomen', we would have assumed that if randomised participants minor heterogeneity might provide overly narrow CIs. We would
had not been included in an analysis, their abdominal wound only have used a fixed-effect approach when we assessed clinical
did not close (e.g. they would have been considered in the and methodological heterogeneity to be minimal and the following
denominator, but not the numerator). assumption held: that a single underlying treatment effect was
being estimated. We would have used Chi2 and I2 tests to
For continuous variables (e.g. length of hospital stay) and for all
quantify heterogeneity, but we would not have used these to
secondary outcomes, we presented available data from the study
guide the choice of model for meta-analysis. We would have
reports or study authors, and did not impute missing data. Where
exercised caution when meta-analysed data were at risk of small-
measures of variance were missing, we calculated these wherever
study effects because a random-effects model might have been
possible. If calculation was not possible, we contacted the study
unsuitable. In this case, or where there were other reasons to
authors. Where these measures of variance were not available, we
question the selection of a fixed-effect or random-effects model, we
would have excluded the study from any relevant meta-analyses
would have assessed the impact of the approach using sensitivity
that we conducted.
analyses to compare results from alternate models. We would have
Assessment of heterogeneity reported any evidence that suggested that the use of a particular
model might not have been robust. We might have meta-analysed
Assessment of heterogeneity can be a complex, multi-faceted even when there was thought to be extensive heterogeneity. We
process. First, we considered clinical and methodological would have attempted to explore the causes behind this using
heterogeneity, that is, the degree to which the included studies meta-regression, if possible (Thompson 1999).
varied in terms of participant, intervention, outcome, and
characteristics such as length of follow-up. If appropriate, we would We presented data using forest plots where possible. For
have supplemented this assessment of clinical and methodological dichotomous outcomes, we presented the summary estimate as a
heterogeneity by information regarding statistical heterogeneity RR with 95% CI. Where continuous outcomes were measured in the
assessed using the Chi2 test (we would have considered a same way across studies, we planned to present a pooled MD with
significance level of P < 0.10 to indicate statistically significant 95% CI; we planned to pool SMD estimates where studies measured
heterogeneity) in conjunction with the I2 statistic (Higgins 2003). the same outcome using different methods. For time-to-event data,
The I2 statistic examines the percentage of total variation across we planned to plot (and, if appropriate, pool) estimates of HRs and
RCTs that is due to heterogeneity rather than chance (Higgins 95% CIs as presented in the study reports using the generic inverse
2003). In general, I2 values of 25% or less may mean a low level of variance method in Review Manager 5 (Review Manager 2020). If
heterogeneity (Higgins 2003), and values of more than 75% indicate time to primary fascial closure had been analysed as a continuous
very high heterogeneity (Deeks 2021). If there had been evidence measure but it was not clear if the open abdomen had healed, we
of high heterogeneity, we would have attempted to explore this would have documented the use of the outcome in the study, but
further: see Data synthesis. would not have summarised the data or used them in any meta-
analysis.
Assessment of reporting biases
We obtained pooled estimates of the treatment effect using Review
Reporting biases arise when the nature and direction of the results Manager 5 (Review Manager 2020).
influences the dissemination of research findings. Publication bias
is one of several possible causes of 'small-study effects', that is, Subgroup analysis and investigation of heterogeneity
a tendency for estimates of the intervention effect to be more
beneficial in smaller RCTs. Funnel plots allow a visual assessment We planned to carry out the following subgroup analyses if there
of whether small-study effects may be present in a meta-analysis. were sufficient studies:
A funnel plot is a simple scatter plot of the intervention effect
• different methods of temporary abdominal closure in the
estimates from individual RCTs against some measure of each trial's
comparator group (e.g. Bogota bag, Wittmann patch, zipper);
size or precision (Page 2021). We planned to present funnel plots for
and
meta-analyses comprising 10 RCTs or more using Review Manager
5 (Review Manager 2020), but we were unable to do this as only two • different aetiologies (e.g. severe peritonitis, severe acute
studies met the inclusion criteria for this review. pancreatitis).

Data synthesis We would have used the following outcomes in subgroup analyses:

We presented details of the included studies in a narrative review • primary fascial closure (time to primary fascial closure and
according to the type of comparator. We considered clinical and proportion of participants with wound with successful primary
methodological heterogeneity, and we would have undertaken fascial closure); and
pooling within comparisons if studies had appeared appropriately • adverse events.
similar in terms of open abdomen aetiology, intervention type,
duration of follow-up, and outcome type. We would have explored differences between subgroups using
random-effects meta-regression, if possible.

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We would have used the formal Chi2 test for subgroup differences • proportion of participants with successful primary fascial
to test for subgroup interactions. We would have compared closure of the abdomen;
subgroups using the analysis option 'test for subgroup differences' • adverse events;
in Review Manager 5 (Review Manager 2020). However, none of this • all-cause mortality; and
was possible as we included an insufficient number of studies in the
• participant health-related quality of life.
review.
We considered the time points and method of outcome
Sensitivity analysis
measurement specified in Types of outcome measures in the
Where possible and appropriate, we planned to perform sensitivity summary of findings tables. When evaluating the risk of bias
analyses to explore the effects of the following criteria: domain, we downgraded the GRADE assessment only when we
classified a study as being at high risk of bias for one or more
• changing between worst-case scenario analysis and best-case domains or when the risk of bias assessment for selection bias
scenario analysis for missing data; (generation of the randomisation sequence domain and the
• excluding studies in which either the mean or standard allocation concealment domain) was unclear. We downgraded the
deviation, or both, were imputed; and GRADE assessment when the risk of bias assessment for blinding
• using the time point specified in the methods as being of was unclear (e.g. classified as unclear for the performance bias
primary interest. domain and the detection bias domain) as well as at high risk of
bias. We did not downgrade for unclear risk of bias assessments in
We would have used the following outcomes in sensitivity analyses: other domains.

• primary fascial closure (time to primary fascial closure and We planned to select an informal optimal information size of
proportion of participants with wound with successful primary 300 for binary outcomes, following the GRADE default value. We
fascial closure); and also followed GRADE guidance and downgraded twice for serious
• adverse events. imprecision when there were very few events and when CIs around
effects included both appreciable benefit and appreciable harm.
We were unable to carry out sensitivity analyses as an insufficient
number of studies were included in the review. We based the Methods section of this review on a standard template
used by Cochrane Wounds.
Summary of findings and assessment of the certainty of the
evidence RESULTS
We present the main results of the review in summary of findings Description of studies
tables. These tables present key information concerning the
certainty of the evidence, the magnitude of the effects of the See 'Characteristics of included studies', 'Characteristics of
interventions examined, and the sum of the available data for the excluded studies', and 'Characteristics of ongoing studies' tables.
main outcomes (Schünemann 2021a). The summary of findings
tables also include an overall grading of the evidence related Results of the search
to each of the main outcomes using the GRADE approach. The We identified 585 records through electronic searches of databases
GRADE approach defines the certainty of a body of evidence as the and 110 trial registry records. We did not identify any records by
extent to which one can be confident that an estimate of effect or scanning reference lists of the identified randomised controlled
association is close to the true quantity of specific interest. The trials (RCTs). We excluded 681 clearly irrelevant records through
certainty of a body of evidence involves consideration of within- reading the titles and abstracts. We retrieved the remaining
trial risk of bias (methodological quality), directness of evidence, 14 records for further assessment. We excluded 10 studies for
heterogeneity, precision of effect estimates, and risk of publication the reasons listed in the 'Characteristics of excluded studies'
bias (Schünemann 2021b). We presented the following outcomes in tables, and we identified two ongoing studies (Kirkpatrick 2018;
the summary of findings tables: Rajabaleyan 2019). Only two RCTs fulfilled the inclusion criteria for
this review (Auer 2021; Rencüzoğulları 2015). We present the study
• time to primary fascial closure of the abdomen;
flow diagram in Figure 1.

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Figure 1. Study flow diagram

Included studies Negative pressure wound therapy (NPWT) versus Bogota bag
We listed details of the studies in the 'Characteristics of included One study randomised 40 participants with open abdomen (33
studies' tables. non-trauma patients and 7 trauma patients) to the NPWT group
(N = 20) or the Bogota bag group (N = 20). This RCT was a single-
centre study conducted in Turkey (Rencüzoğulları 2015). This RCT

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did not describe the sample size calculation. The mean age of the threshold we set (of 25% of participants or less), or both (Bee 2008;
participants was 50.9 years, and the mean proportion of women Correa 2016; Kirkpatrick 2015; Long 2014). We excluded one trial
was 42.5%. The size of the wound was comparable between the because the use of NPWT during the treatment period was not the
NPWT group and the Bogota bag group. The outcomes reported only systematic difference between treatment groups. The primary
were time to primary fascial closure of the abdomen, adverse intervention in this study was retentions sutured sequential fascial
events (fistulae formation), all-cause mortality, length of hospital closure (a method of temporary abdominal closure) rather than
stay, and intra-abdominal pressure. This study did not report the NPWT (Pliakos 2010). We excluded the remaining studies because
funding source or any conflicts of interest. they were not randomised controlled trials (Barker 2000; Fortelny
2014; Kurt 2021; Perathoner 2010; Villalobos 2020).
NPWT versus any other type of temporary abdominal closure
Ongoing studies
We did not identify any randomised controlled trials comparing
NPWT to any other type of temporary abdominal closure. Kirkpatrick 2018: 550 participants with severe complicated intra-
abdominal sepsis will be randomised to NPWT management or
Type of NPWT closed abdomen management. This trial is currently recruiting
One study randomised 34 participants with open abdomen (31 participants; it is being performed in Canada and began in May
non-trauma patients and 3 trauma patients) to a type of NPWT 2017. The primary outcome is the rate of survival of participants.
(Suprasorb CNP system; N = 17) or another type of NPWT (ABThera The secondary outcomes are the length of days in the intensive
system; N = 17). This RCT was a single-centre study conducted care unit and the concentrations of blood IL-6 ('Characteristics of
in Austria (Auer 2021). This RCT did describe the sample size ongoing studies' tables).
calculation. The mean age of the participants was 55.0 years, and
Rajabaleyan 2019: 320 participants with faecal or diffuse peritonitis
the mean proportion of women was 35.3%. The outcomes reported
will be randomised to NPWT management or closed abdomen
were proportion of participants with successful primary fascial
management. This trial has not yet recruited participants; it is being
closure of the abdomen, adverse events (fistulae formation), all-
performed in Canada and began in April 2019. The primary outcome
cause mortality, and reoperation rate. A non-commercial grant
is peritonitis-related complications. The secondary outcomes are
funded this study. This study did not report any conflicts of interest.
quality of life, ventral hernia rate, and cost-effective analysis
Excluded studies ('Characteristics of ongoing studies' tables).

We excluded 10 studies, and the details are listed in the Risk of bias in included studies
'Characteristics of excluded studies' tables. We excluded four trials
because they involved both trauma and non-trauma patients, and Figure 2 and Figure 3 show the risk of bias of the included studies.
the results for non-trauma patients were not presented separately Both studies were at high risk of bias (Auer 2021; Rencüzoğulları
or the proportion of non-trauma participants was larger than the 2015).

Figure 2. Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages
across all included studies

Random sequence generation (selection bias)

Allocation concealment (selection bias)
Blinding of participants and personnel (performance bias): All outcomes
Blinding of outcome assessment (detection bias): All outcomes
Incomplete outcome data (attrition bias): All outcomes
Selective reporting (reporting bias)
Other bias

0% 25% 50% 75% 100%

Low risk of bias Unclear risk of bias High risk of bias

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Figure 3. Risk of bias summary: review authors' judgements about each risk of bias item for each included study

Blinding of participants and personnel (performance bias): All outcomes

Blinding of outcome assessment (detection bias): All outcomes
Incomplete outcome data (attrition bias): All outcomes
Random sequence generation (selection bias)
Allocation concealment (selection bias)

Selective reporting (reporting bias)

Other bias

Auer 2021 + + - - + + -
Rencüzoğulları 2015 ? ? - - + + +

Allocation Blinding
We judged random sequence generation and allocation Due to the nature of the interventions, performing surgeons could
concealment to be at low risk of bias in one study (Auer 2021). not be blinded to group allocation in either study (Auer 2021;
Random sequence generation and allocation concealment were at Rencüzoğulları 2015). We therefore judged both studies to be
unclear risk of bias for the second study: the paper provided no at high risk of bias for blinding of participants and personnel.
specific information, and there was no response to our queries from However, it should be possible to ensure blinding of outcome
the study authors (Rencüzoğulları 2015). assessors. The study authors stated that both studies could not
be defined as blinded (Auer 2021; Rencüzoğulları 2015). Thus, we

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judged that blinding of outcome assessment was also at high risk random sequence generation and allocation concealment and high
of bias for both studies. risk of bias for blinding of outcome assessment), once for serious
indirectness (33 non-trauma patients and 7 trauma patients),
Incomplete outcome data and twice for very serious imprecision (small sample size and
There were no postrandomisation dropouts in either study (Auer wide confidence intervals) (Summary of findings 1). The fistulae
2021; Rencüzoğulları 2015). Thus, we considered both studies to be formation rate was 10% in the NPWT group (N = 2) and 5% in the
at low risk of attrition bias. Bogota bag group (N = 1) (risk ratio (RR) 2.00, 95% CI 0.20 to 20.33).

Selective reporting All-cause mortality

The study protocols were not available for either study, but both Rencüzoğulları 2015 reported all-cause mortality. It is uncertain if
studies included results for key outcomes that would be expected there is a difference between NPWT and the Bogota bag in terms
to have been reported for such studies (Auer 2021; Rencüzoğulları of all-cause mortality (Analysis 1.3). We assessed the evidence
2015). Thus, we judged that selective reporting was at low risk of as being of very low certainty; we downgraded once for serious
bias for both studies. indirectness (33 non-trauma patients and 7 trauma patients) and
twice for very serious imprecision (small sample size and wide
Other potential sources of bias confidence intervals). We did not downgrade the certainty of
evidence for all-cause mortality for risk of bias because it was
Baseline imbalance was at high risk of bias for one study (Auer unlikely to be affected by performance bias and detection bias
2021). Baseline imbalance was at low risk of bias for the other study (Summary of findings 1). The all-cause mortality was 25% in the
(Rencüzoğulları 2015). NPWT group (N = 5) and 35% in the Bogota bag group (N = 7) (RR
0.71, 95% CI 0.27 to 1.88).
Effects of interventions
See: Summary of findings 1 NPWT compared with the Bogota Participant health-related quality of life or health status
bag for managing the open abdomen in non-trauma patients; The study did not report this outcome.
Summary of findings 2 Suprasorb CNP system compared with the
ABThera system for managing the open abdomen in non-trauma Length of hospital stay
patients
Rencüzoğulları 2015 reported length of hospital stay. It is uncertain
NPWT versus Bogota bag (1 study: 40 participants) if there is a difference between NPWT and the Bogota bag in terms
of length of hospital stay (Analysis 1.4). We assessed the evidence
Time to primary fascial closure of the abdomen as being of very low certainty; we downgraded twice for very
Rencüzoğulları 2015 reported time to primary fascial closure of the serious risk of bias (unclear risk of random sequence generation
abdomen. It is uncertain if there is a difference between NPWT and allocation concealment and high risk of bias for blinding
and the Bogota bag in terms of mean time to primary fascial of outcome assessment), once for serious indirectness (33 non-
closure of the abdomen (Analysis 1.1). We graded the available trauma patients and 7 trauma patients), and twice for very serious
evidence to be of very low certainty; we downgraded twice for very imprecision (small sample size and wide confidence intervals). The
serious risk of bias (unclear risk of random sequence generation mean (SD) length of hospital stay was 28.5 (21.3) days for the NPWT
and allocation concealment and high risk of bias for blinding group and 27.4 (25.3) days for the Bogota bag group (MD 1.10 days,
of outcome assessment), once for serious indirectness (33 non- 95% CI -13.39 to 15.59).
trauma participants and 7 trauma participants), and twice for
Reoperation rate
very serious imprecision (small sample size and wide confidence
interval) (Summary of findings 1). The mean (standard deviation The study did not report this outcome.
(SD)) time to primary fascial closure of the abdomen in the NPWT
group was 16.9 (3.2) days, and the mean (SD) time to primary fascial Wound infection
closure of the abdomen in the Bogota bag group was 20.5 (9.9) The study did not report this outcome.
days (mean difference (MD) -3.60 days, 95% confidence interval (CI)
-8.16 to 0.96 days). However, this study did not report whether all Pain
of the participants reached primary fascial closure, and there was
no response to our queries from the study authors, so we cannot be The study did not report this outcome.
sure of the reliability of these data.
NPWT versus any other type of temporary abdominal closure
Proportion of participants with successful primary fascial There were no randomised controlled trials comparing NPWT with
closure of the abdomen any other type of temporary abdominal closure.
The study did not report this outcome.
Comparison of different NPWT devices (1 study: 34
Adverse events participants)

Rencüzoğulları 2015 reported fistulae formation as an adverse One study compared a type of NPWT (Suprasorb CNP system) with
event. It is uncertain if there is a difference between NPWT and another type of NPWT (ABThera system) for managing the open
the Bogota bag in terms of fistulae formation (Analysis 1.2). abdomen (Auer 2021).
We assessed the evidence as being of very low certainty; we
downgraded twice for very serious risk of bias (unclear risk of

Negative pressure wound therapy for managing the open abdomen in non-trauma patients (Review) 16
Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Cochrane Trusted evidence.
Informed decisions.
Library Better health. Cochrane Database of Systematic Reviews

Time to primary fascial closure of the abdomen system in terms of reoperation rate (Analysis 2.4). We assessed
the evidence as of very low certainty; we downgraded twice for
The study did not report this outcome.
very serious risk of bias (high risk of bias for blinding of outcome
Proportion of participants with successful primary fascial assessment and baseline imbalance), once for serious indirectness
closure of the abdomen (31 non-trauma patients and 3 trauma patients), and once for
serious imprecision (small sample size). The reoperation rate was
Auer 2021 reported proportion of participants with successful 100% in the Suprasorb CNP group (N = 17) and 100% in the ABThera
primary fascial closure of the abdomen. It is uncertain if there is group (N = 17) (RR 1.00, 95% CI 0.90 to 1.12).
a difference between the Suprasorb CNP system and the ABThera
system in terms of proportion of participants with successful Wound infection
primary fascial closure of the abdomen (Analysis 2.1). We assessed
The study did not report this outcome.
the evidence as of very low certainty; we downgraded twice for
very serious risk of bias (high risk of bias for blinding of outcome Pain
assessment and baseline imbalance), once for serious indirectness
(31 non-trauma patients and 3 trauma patients), and twice for The study did not report this outcome.
very serious imprecision (small sample size and wide confidence
Subgroup analysis
intervals) (Summary of findings 2). The proportion of participants
with successful primary fascial closure of the abdomen was 88.2% We did not perform any of the planned subgroup analyses because
in the Suprasorb CNP group (N = 15) and 70.6% in the ABThera this review included only two studies.
group (N = 12) (RR 0.80, 95% CI 0.56 to 1.14).
Sensitivity analysis
Adverse events
We did not perform any of the planned sensitivity analyses because
Auer 2021 reported fistulae formation as an adverse event. It this review included only two studies.
is uncertain if there is a difference between the Suprasorb CNP
system and the ABThera system in terms of fistulae formation DISCUSSION
(Analysis 2.2). We assessed the evidence as of very low certainty;
we downgraded twice for very serious risk of bias (high risk of Summary of main results
bias for blinding of outcome assessment and baseline imbalance),
Evidence from two studies, with a total of 74 participants with open
once for serious indirectness (31 non-trauma patients and 3 trauma
abdomen, contributed data to the outcomes of interest for this
patients), and twice for very serious imprecision (small sample
review.
size and wide confidence intervals) (Summary of findings 2). The
fistulae formation rate was 0% in the Suprasorb CNP group (N = 0) One study (40 participants) compared negative pressure wound
and 23.5% in the ABThera group (N = 4) (RR 0.11, 95% CI 0.01 to therapy (NPWT) with a Bogota bag for managing the open abdomen
1.92). in 33 non-trauma patients and 7 trauma patients. We are uncertain
whether there were differences between NPWT and the Bogota
All-cause mortality
bag in terms of primary fascial closure of the abdomen, adverse
Auer 2021 reported all-cause mortality. It is uncertain if there is events, all-cause mortality, or length of hospital stay. The study
a difference between the Suprasorb CNP system and the ABThera did not report the proportion of participants with successful
system in terms of all-cause mortality (Analysis 2.3). We assessed primary fascial closure of the abdomen, participant health-related
the evidence as of very low certainty; we downgraded once quality of life, reoperation rate, wound infection, or pain. Another
for serious risk of bias (baseline imbalance), once for serious study (34 participants) compared different types of NPWT systems
indirectness (31 non-trauma patients and 3 trauma patients), and (Suprasorb CNP system versus ABThera system) for managing the
twice for very serious imprecision (small sample size and wide open abdomen in 31 non-trauma patients and 3 trauma patients.
confidence intervals). We did not downgrade the certainty of We are uncertain whether there were differences between these
evidence for all-cause mortality for lack of blinding because this is systems in terms of primary fascial closure of the abdomen, adverse
considered an objective outcome, which is unlikely to be affected events, all-cause mortality, or reoperation rate. The study did
by performance bias and detection bias (Summary of findings 2). not report the time to primary fascial closure of the abdomen,
The all-cause mortality was 5.9% in the Suprasorb CNP group (N = participant health-related quality of life, length of hospital stay,
1) and 17.6% in the ABThera group (N = 3) (RR 0.33, 95% CI 0.04 to wound infection, or pain. These results were based on very
2.89). low-certainty evidence, which we downgraded for risk of bias,
indirectness, and imprecision.
Participant health-related quality of life or health status
We did not identify any randomised controlled trials comparing
The study did not report this outcome. NPWT with any other type of temporary abdominal closure.
Length of hospital stay
Overall completeness and applicability of evidence
The study did not report this outcome.
The study included 74 adults with open abdomen for various
Reoperation rate diseases, including severe peritonitis (N = 55), malignancy (N = 9),
and trauma (N = 10). The majority of the participants were non-
Auer 2021 reported reoperation rate. It is uncertain if there is a trauma patients (N = 64; 86.5%). Therefore, the results of this review
difference between the Suprasorb CNP system and the ABThera

Negative pressure wound therapy for managing the open abdomen in non-trauma patients (Review) 17
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 Cochrane Trusted evidence.
Informed decisions.
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are applicable to adults with open abdomen for various abdominal We excluded Bee 2008 for the reasons given above. We
diseases, especially for non-trauma patients. excluded Pliakos 2010 because the primary intervention in this
study was not NPWT (NPWT + retentions sutured sequential
Quality of the evidence fascial closure versus NPWT). NICE guidelines concluded that
the evidence on the safety and efficacy of NPWT for the open
Both studies were at high risk of bias due to the risk of performance
abdomen was adequate to support the use of this procedure, but
bias and detection bias. There were too few studies included for
they also encouraged more research on this issue. The findings
each comparison to assess inconsistency and publication bias.
from our review agreed with the NICE guidelines that further
There was indirectness of evidence because the studies included
robust randomised controlled trial research would help to reduce
10 trauma patients. The sample size was small and the confidence
uncertainty regarding the effectiveness and safety of NPWT for
intervals of the majority of outcomes were wide, indicating that the
managing the open abdomen after surgery in people who have not
estimates of effect obtained were imprecise. Overall, we considered
experienced trauma.
the certainty of the evidence to be very low (Summary of findings
1; Summary of findings 2).
AUTHORS' CONCLUSIONS
Potential biases in the review process
Implications for practice
There were some unavoidable potential biases of note in the
Based on the available trial data, we are uncertain whether negative
review process. First, when we contacted some of the investigators
pressure wound therapy (NPWT) has any benefit in terms of primary
to request further information, we did not obtain a thorough
fascial closure of the abdomen, adverse events (fistulae formation),
reply. Thus, the missing data may introduce bias to this review.
all-cause mortality, or length of hospital stay compared with a
Additionally, we were unable to explore publication bias because
Bogota bag. We are also uncertain whether the Suprasorb CNP
we did not have access to the protocols for either included study
system has any benefit in primary fascial closure of the abdomen,
(Auer 2021; Rencüzoğulları 2015).
adverse events, all-cause mortality, or reoperation rate compared
Agreements and disagreements with other studies or with the ABThera system. Given the uncertainty of evidence in this
review, clinicians, patients, and other stakeholders may need to
reviews
take into account other considerations when making treatment
We found one systematic review that evaluated various temporary decisions.
abdominal closure techniques (e.g. NPWT, mesh, Bogota bag,
zipper) for managing the open abdomen in non-trauma patients Implications for research
(Atema 2015). The review included 74 studies describing 78 case Although two studies are ongoing and their results will hopefully
series; however, only one of the included studies was a randomised add to the evidence regarding open abdomen (Kirkpatrick 2018;
controlled trial (Robledo 2007). Atema 2015 found that NPWT with Rajabaleyan 2019), there is an urgent need for more high-quality
continuous fascial traction was associated with better outcomes in trials on this topic. We will update this review when data from the
terms of primary fascial closure of the abdomen, although it had large ongoing studies are available.
a higher risk of fistulae formation. Atema 2015 did not make any
recommendations because the overall certainty of the available The design of future randomised controlled trials should consider
evidence was very low. We did not include Robledo 2007 because carefully ongoing trials and stakeholder priorities in this field
the study compared open versus closed management of the open in terms of participant populations, priority comparisons, and
abdomen in people with severe peritonitis. outcomes. Future research should report clinically important
outcomes, such as primary fascial closure of the abdomen. Other
We found another systematic review that compared NPWT and outcomes to consider in conjunction with stakeholders in trial
non-NPWT techniques for managing the open abdomen (Cirocchi design include participant health-related quality of life, reoperation
2016). The review included two randomised controlled trials (Bee rate, wound infection, and pain outcomes. Current practices and
2008; Rencüzoğulları 2015); however, we excluded one of the two national or international epidemiological data that indicate the
studies from our review (Bee 2008), as the majority of participants size and need of different groups may inform the choice of study
in the randomised controlled trial (90%) were trauma patients, and population.
the results for non-trauma patients were not presented separately.
We included the other study in our review (Rencüzoğulları 2015). Trial design should be robust with use of blinded outcome
The Cirocchi 2016 review concluded that NPWT was associated assessment where possible, especially for more subjective
with better outcomes than non-NPWT techniques for managing outcomes such as primary fascial closure of the abdomen. Study
the open abdomen. However, Cirocchi 2016 did not conduct a sample sizes need to reflect the clinically important differences of
GRADE assessment. Our review includes GRADE assessments, and the selected primary outcomes.
the findings do not agree with those of the Cirocchi 2016 review. Our
review found that it is uncertain whether NPWT is better than non- ACKNOWLEDGEMENTS
NPWT techniques (e.g. Bogota bag).
The authors are grateful to the following specialist and consumer
Finally, National Institute for Health and Care Excellence (NICE) peer reviewers for their time and comments: Janet Gunderson
guidelines reviewed the data regarding the use of NPWT for (protocol and review), Jason Wong (protocol and review), AG
managing the open abdomen (NICE 2013). These guidelines Radhika (review), Gill Norman (review), Sarah Rhodes (protocol),
included two randomised controlled trials (Bee 2008; Pliakos and Zhenmi Liu (protocol); and for the contribution of copy editors
2010); however, we excluded both studies from our review. Anne Lawson (protocol) and Laura Prescott (review).

Negative pressure wound therapy for managing the open abdomen in non-trauma patients (Review) 18
Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Cochrane Trusted evidence.
Informed decisions.
Library Better health. Cochrane Database of Systematic Reviews

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CHARACTERISTICS OF STUDIES

Characteristics of included studies [ordered by study ID]

Auer 2021
Study characteristics

Methods Randomised controlled trial

Participants Country: Austria, single centre

Study dates: August 2010 to September 2012

Number randomised: 34
Postrandomisation dropout: 0 (0%)

Description of sample size calculation: yes

Age range: 23.0 to 79.0

Mean age: 55.0 years

Females: 12 (35.3%)

Severe peritonitis: 31 (91.2%)

Abdominal trauma: 3 (8.8%)

Other etiologies: 0 (0%)

Inclusion criteria

• People with secondary peritonitis in at least 2 abdominal quadrants

• People who had exhibited peritonitis for more than 24 hours and in whom a second look was planned
or for whom the abdomen could not be closed for other reasons
• People presenting with abdominal compartment syndrome for whom the indication for open abdom-
inal treatment after failure of conservative treatment was made
• People after abdominal trauma combined with abdominal compartment syndrome or contaminated
abdomen due to enteral perforation, or both

Exclusion criteria

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Auer 2021 (Continued)

• People with pancreatitis as the source of peritonitis
• People with active abdominal bleeding
• Pregnancy
• People under 18 years of age

Interventions Participants were randomly assigned to 2 groups:

Group 1: Suprasorb CNP System (N = 17)
Group 2: ABThera system (N = 17)

Outcomes The outcomes reported were:

• proportion of participants with successful primary fascial closure of the abdomen;

• adverse events (fistulae formation);
• all-cause mortality; and
• reoperation rate.

Notes Funding source: medical university scientific budget

Declarations of interest: none declared

Risk of bias

Bias Authors' judgement Support for judgement

Random sequence genera- Low risk Quote: "Patients were randomly assigned to experimental groups using the
tion (selection bias) web-based randomizer."

Comment: computer-generated numbers

Allocation concealment Low risk Quote: "The inclusion was carried out without any influence from the treating
(selection bias) surgeon by calling up the selection decision on the web based randomizer."

Comment: central allocation

Blinding of participants High risk Comment: the surgeons could not be blinded to group allocation.
and personnel (perfor-
mance bias)
All outcomes

Blinding of outcome as- High risk Quote: "Even if the assessment was carried out by 2 surgeons on the basis of
sessment (detection bias) photos presented, the study could not be blinded."
All outcomes

Incomplete outcome data Low risk Comment: there were no postrandomisation dropouts.
(attrition bias)
All outcomes

Selective reporting (re- Low risk Comment: the study protocol was not available; the study included results for
porting bias) expected key outcomes.

Other bias High risk Quote: "The values of BMI are displayed in Table 1E. The difference between
the groups was significant."

Comment: baseline imbalance

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Rencüzoğulları 2015
Study characteristics

Methods Randomised controlled trial

Participants Country: Turkey, single centre

Study dates: not reported

Number randomised: 40
Postrandomisation dropout: 0 (0%)

Description of sample size calculation: no

Age range: 24.0 to 81.0

Mean age: 50.9 years
Females: 17 (42.5%)

Severe peritonitis: 24 (60%)

Abdominal trauma: 7 (17.5%)

Other etiologies: 9 (22.5%)

Inclusion criteria

• People undergoing decompressive laparotomy as part of the treatment for abdominal compartment
syndrome
• People who were under follow-up in the surgical intensive care unit
• People who developed abdominal compartment syndrome as a result of progressively increasing in-
tra-abdominal pressure

Exclusion criteria

• People with American Society of Anesthesologists score 5

Interventions Participants were randomly assigned to 2 groups:

Group 1: vacuum-assisted closure (N = 20)
Group 2: Bogota bag (N = 20)

Outcomes The outcomes reported were:

• primary fascial closure of the abdomen;

• adverse events (fistulae formation);
• all-cause mortality;
• length of hospital stay; and
• intra-abdominal pressure.

Notes Vacuum-assisted closure system (V.A.C., KCI, San Antonio, TX) was applied to temporary abdominal clo-
sure.

Funding source: not reported

Declarations of interest: not reported

Risk of bias

Bias Authors' judgement Support for judgement

Random sequence genera- Unclear risk Comment: the paper did not provide any information about sequence genera-
tion (selection bias) tion.

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Rencüzoğulları 2015 (Continued)

Allocation concealment Unclear risk Comment: the paper did not provide any information about allocation con-
(selection bias) cealment.

Blinding of participants High risk Author reply: "We cannot define as blinded, as [the] surgical and postoperative
and personnel (perfor- care team were aware of randomization."
mance bias)
All outcomes

Blinding of outcome as- High risk Author reply: "We cannot define as blinded, as [the] surgical and postoperative
sessment (detection bias) care team were aware of randomization."
All outcomes

Incomplete outcome data Low risk Comment: there were no postrandomisation dropouts.
(attrition bias)
All outcomes

Selective reporting (re- Low risk Comment: the study protocol was not available; the study included results for
porting bias) expected key outcomes.

Other bias Low risk Comment: the study appeared to be free of other sources of bias.

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Barker 2000 This was a non-randomised study.

Bee 2008 The majority of participants in this randomised controlled trial (90%) were trauma patients, and
the results for non-trauma patients were not presented separately.

Correa 2016 A total of 52% of the participants in this randomised controlled trial were trauma patients, and the
results for non-trauma patients were not presented separately.

Fortelny 2014 This was a non-randomised study.

Kirkpatrick 2015 A total of 46% of the participants in this randomised controlled trial were trauma patients, and the
results for non-trauma patients were not presented separately.

Kurt 2021 This was a non-randomised study.

Long 2014 A total of 35% of the participants in this randomised controlled trial were trauma patients, and the
results for non-trauma patients were not presented separately.

Perathoner 2010 This was a non-randomised study.

Pliakos 2010 This was a randomised controlled trial comparing negative pressure wound therapy (NPWT) + re-
tentions sutured sequential fascial closure versus NPWT. Thus, the primary intervention was reten-
tions sutured sequential fascial closure rather than NPWT.

Villalobos 2020 This was a non-randomised study.

Characteristics of ongoing studies [ordered by study ID]

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Kirkpatrick 2018
Study name Closed or open after source control laparotomy for severe complicated intra-abdominal sepsis (the
COOL trial): study protocol for a randomised controlled trial

Methods Randomised controlled trial

Participants Country: Canada

Number at enrolment: 550

Inclusion criteria

• Presence of purulent, feculent, or enteric spillage over at least 2 intraperitoneal quadrants intra-
operatively
• Septic shock
• Predisposition, Infection, Response and Organ Dysfunction score > 3
• World Society of Emergency Surgery Sepsis Severity score > 8

Exclusion criteria

• Pregnant
• Confirmed or strongly suspected severe intra-abdominal hypertension (intra-abdominal pressure
> 20 mmHg)
• No intention of providing ongoing care
• Pancreatitis as the source of peritonitis
• Uncontrolled bleeding

Interventions Participants were randomly assigned to 2 groups:

Group 1: negative pressure wound therapy management
Group 2: closed abdomen management

Outcomes The primary outcome is the rate of survival of participants.

The secondary outcomes are the length of days in intensive care unit and the concentrations of
blood interleukin-6.

Starting date May 2017

Contact information Principal investigator: Andrew W Kirkpatrick, University of Calgary, Canada

Email: [email protected]

Notes

Rajabaleyan 2019
Study name Vacuum assisted closure versus on-demand re-laparotomy in patients with faecal or diffuse peri-
tonitis: a multicenter randomised controlled trial (VACOR)

Methods Randomised controlled trial

Participants Country: Denmark

Number at enrolment: 320

Inclusion criteria

• Age over 18
• Suspected faecal peritonitis originating from the small intestine, colon, or rectum

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Rajabaleyan 2019 (Continued)

Exclusion criteria

• Primary peritonitis
• Abdominal trauma
• Lack of consent

Interventions Participants were randomly assigned to 2 groups:

Group 1: negative pressure wound therapy management
Group 2: closed abdomen management

Outcomes The primary outcome is peritonitis-related complications.

The secondary outcomes are quality of life, ventral hernia rate, and cost-effective analysis.

Starting date April 2019

Contact information Principal investigator: Pooya Rajabaleyan, Odense University Hospital, Denmark

Email: [email protected]

Notes

DATA AND ANALYSES

Comparison 1. NPWT versus Bogota bag

Outcome or subgroup title No. of studies No. of partici- Statistical method Effect size
pants

1.1 Time to primary fascial clo- 1 40 Mean Difference (IV, Fixed, 95% CI) -3.60 [-8.16, 0.96]
sure of the abdomen

1.2 Adverse events 1 40 Risk Ratio (M-H, Fixed, 95% CI) 2.00 [0.20, 20.33]

1.3 All-cause mortality 1 40 Risk Ratio (M-H, Fixed, 95% CI) 0.71 [0.27, 1.88]

1.4 Length of hospital stay 1 40 Mean Difference (IV, Fixed, 95% CI) 1.10 [-13.39, 15.59]

Analysis 1.1. Comparison 1: NPWT versus Bogota bag, Outcome 1: Time to primary fascial closure of the abdomen

NPWT Bogota bag Mean Difference Mean Difference

Study or Subgroup Mean SD Total Mean SD Total Weight IV, Fixed, 95% CI IV, Fixed, 95% CI

Rencüzoğulları 2015 (1) 16.9 3.2 20 20.5 9.9 20 100.0% -3.60 [-8.16 , 0.96]

Total (95% CI) 20 20 100.0% -3.60 [-8.16 , 0.96]

Heterogeneity: Not applicable
Test for overall effect: Z = 1.55 (P = 0.12) -100 -50 0 50 100
Test for subgroup differences: Not applicable Favours NPWT Favours Bogota bag

Footnotes
(1) These may not be reliable data, because this study did not report whether all participants reached primary fascial closure and there was no response to our queries from the study authors.

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Analysis 1.2. Comparison 1: NPWT versus Bogota bag, Outcome 2: Adverse events

NPWT Bogota bag Risk Ratio Risk Ratio

Study or Subgroup Events Total Events Total Weight M-H, Fixed, 95% CI M-H, Fixed, 95% CI

Rencüzoğulları 2015 2 20 1 20 100.0% 2.00 [0.20 , 20.33]

Total (95% CI) 20 20 100.0% 2.00 [0.20 , 20.33]

Total events: 2 1
Heterogeneity: Not applicable 0.01 0.1 1 10 100
Test for overall effect: Z = 0.59 (P = 0.56) Favours NPWT Favours Bogota bag
Test for subgroup differences: Not applicable

Analysis 1.3. Comparison 1: NPWT versus Bogota bag, Outcome 3: All-cause mortality

NPWT Bogota bag Risk Ratio Risk Ratio

Study or Subgroup Events Total Events Total Weight M-H, Fixed, 95% CI M-H, Fixed, 95% CI

Rencüzoğulları 2015 5 20 7 20 100.0% 0.71 [0.27 , 1.88]

Total (95% CI) 20 20 100.0% 0.71 [0.27 , 1.88]

Total events: 5 7
Heterogeneity: Not applicable 0.01 0.1 1 10 100
Test for overall effect: Z = 0.68 (P = 0.49) Favours NPWT Favours Bogota bag
Test for subgroup differences: Not applicable

Analysis 1.4. Comparison 1: NPWT versus Bogota bag, Outcome 4: Length of hospital stay

NPWT Bogota bag Mean Difference Mean Difference

Study or Subgroup Mean SD Total Mean SD Total Weight IV, Fixed, 95% CI IV, Fixed, 95% CI

Rencüzoğulları 2015 28.5 21.3 20 27.4 25.3 20 100.0% 1.10 [-13.39 , 15.59]

Total (95% CI) 20 20 100.0% 1.10 [-13.39 , 15.59]

Heterogeneity: Not applicable
Test for overall effect: Z = 0.15 (P = 0.88) -100 -50 0 50 100
Test for subgroup differences: Not applicable Favours NPWT Favours Bogota bag

Comparison 2. Suprasorb CNP system versus ABThera system

Outcome or subgroup title No. of studies No. of partici- Statistical method Effect size
pants

2.1 Proportion of participants with 1 34 Risk Ratio (M-H, Fixed, 95% CI) 0.80 [0.56, 1.14]
successful primary fascial closure of
the abdomen

2.2 Adverse events 1 34 Risk Ratio (M-H, Fixed, 95% CI) 0.11 [0.01, 1.92]

2.3 All-cause mortality 1 34 Risk Ratio (M-H, Fixed, 95% CI) 0.33 [0.04, 2.89]

2.4 Reoperation rate 1 34 Risk Ratio (M-H, Fixed, 95% CI) 1.00 [0.90, 1.12]

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Analysis 2.1. Comparison 2: Suprasorb CNP system versus ABThera system, Outcome
1: Proportion of participants with successful primary fascial closure of the abdomen

ABThera system Suprasorb CNP System Risk Ratio Risk Ratio

Study or Subgroup Events Total Events Total Weight M-H, Fixed, 95% CI M-H, Fixed, 95% CI

Auer 2021 12 17 15 17 100.0% 0.80 [0.56 , 1.14]

Total (95% CI) 17 17 100.0% 0.80 [0.56 , 1.14]

Total events: 12 15
Heterogeneity: Not applicable 0.01 0.1 1 10 100
Test for overall effect: Z = 1.24 (P = 0.21) Favours Suprasorb CNP System Favours ABThera system
Test for subgroup differences: Not applicable

Analysis 2.2. Comparison 2: Suprasorb CNP system versus ABThera system, Outcome 2: Adverse events

Suprasorb CNP System ABThera system Risk Ratio Risk Ratio

Study or Subgroup Events Total Events Total Weight M-H, Fixed, 95% CI M-H, Fixed, 95% CI

Auer 2021 0 17 4 17 100.0% 0.11 [0.01 , 1.92]

Total (95% CI) 17 17 100.0% 0.11 [0.01 , 1.92]

Total events: 0 4
Heterogeneity: Not applicable 0.01 0.1 1 10 100
Test for overall effect: Z = 1.51 (P = 0.13) Favours Suprasorb CNP System Favours ABThera system
Test for subgroup differences: Not applicable

Analysis 2.3. Comparison 2: Suprasorb CNP system versus ABThera system, Outcome 3: All-cause mortality

Suprasorb CNP System ABThera system Risk Ratio Risk Ratio

Study or Subgroup Events Total Events Total Weight M-H, Fixed, 95% CI M-H, Fixed, 95% CI

Auer 2021 1 17 3 17 100.0% 0.33 [0.04 , 2.89]

Total (95% CI) 17 17 100.0% 0.33 [0.04 , 2.89]

Total events: 1 3
Heterogeneity: Not applicable 0.01 0.1 1 10 100
Test for overall effect: Z = 1.00 (P = 0.32) Favours Suprasorb CNP System Favours ABThera system
Test for subgroup differences: Not applicable

Analysis 2.4. Comparison 2: Suprasorb CNP system versus ABThera system, Outcome 4: Reoperation rate

Suprasorb CNP system ABThera system Risk Ratio Risk Ratio

Study or Subgroup Events Total Events Total Weight M-H, Fixed, 95% CI M-H, Fixed, 95% CI

Auer 2021 17 17 17 17 100.0% 1.00 [0.90 , 1.12]

Total (95% CI) 17 17 100.0% 1.00 [0.90 , 1.12]

Total events: 17 17
Heterogeneity: Not applicable 0.5 0.7 1 1.5 2
Test for overall effect: Z = 0.00 (P = 1.00) Favours Suprasorb CNP system Favours ABThera system
Test for subgroup differences: Not applicable

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APPENDICES

Appendix 1. Search strategies

Cochrane Wounds Specialised Register

1 MESH DESCRIPTOR Negative-Pressure Wound Therapy EXPLODE ALL AND INREGISTER

2 MESH DESCRIPTOR Suction EXPLODE ALL AND INREGISTER

3 MESH DESCRIPTOR Vacuum EXPLODE ALL AND INREGISTER

4 ("negative pressure" or negative-pressure or TNP or NWPT or NPWT) AND INREGISTER

5 (sub-atmospheric or subatmospheric) AND INREGISTER

6 ((seal* next surface*) or (seal* next aspirat*)) AND INREGISTER

7 (wound near2 suction*) AND INREGISTER

8 (wound near5 drainage) AND INREGISTER

9 ((foam next suction) or (suction next dressing*)) AND INREGISTER

10 ((vacuum next therapy) or (vacuum next dressing*) or (vacuum next seal*) or (vacuum next assist*) or (vacuum near closure) or (vacuum
next compression) or (vacuum next pack*) or (vacuum next drainage) or (suction near drainage) or VAC) AND INREGISTER

11 #1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 AND INREGISTER

12 MESH DESCRIPTOR Abdomen EXPLODE ALL WITH QUALIFIER SU AND INREGISTER

13 MESH DESCRIPTOR Laparotomy EXPLODE ALL AND INREGISTER

14 MESH DESCRIPTOR Abdominal Injuries EXPLODE ALL AND INREGISTER

15 MESH DESCRIPTOR Abdominal Cavity EXPLODE ALL AND INREGISTER

16 MESH DESCRIPTOR Abdominal Wall EXPLODE ALL AND INREGISTER

17 ("open abdomen" or "open abdominal" or "abdominal closure") AND INREGISTER

18 #12 OR #13 OR #14 OR #15 OR #16 OR #17 AND INREGISTER

19 #11 AND #18 AND INREGISTER

The Cochrane Central Register of Controlled Clinical Trials (CENTRAL) searched via Cochrane Register of Studies

1 MESH DESCRIPTOR Negative-Pressure Wound Therapy EXPLODE ALL AND CENTRAL:TARGET

2 MESH DESCRIPTOR Suction EXPLODE ALL AND CENTRAL:TARGET

3 MESH DESCRIPTOR Vacuum EXPLODE ALL AND CENTRAL:TARGET

4 ("negative pressure" or negative-pressure or TNP or NWPT or NPWT) AND CENTRAL:TARGET

5 (sub-atmospheric or subatmospheric) AND CENTRAL:TARGET

6 ((seal* next surface*) or (seal* next aspirat*)) AND CENTRAL:TARGET

7 (wound near2 suction*) AND CENTRAL:TARGET

8 (wound near5 drainage) AND CENTRAL:TARGET

9 ((foam next suction) or (suction next dressing*)) AND CENTRAL:TARGET

10 ((vacuum next therapy) or (vacuum next dressing*) or (vacuum next seal*) or (vacuum next assist*) or (vacuum near closure) or (vacuum
next compression) or (vacuum next pack*) or (vacuum next drainage) or (suction near drainage) or VAC) AND CENTRAL:TARGET

11 #1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 AND CENTRAL:TARGET

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12 MESH DESCRIPTOR Abdomen EXPLODE ALL WITH QUALIFIER SU AND CENTRAL:TARGET

13 MESH DESCRIPTOR Laparotomy EXPLODE ALL AND CENTRAL:TARGET

14 MESH DESCRIPTOR Abdominal Injuries EXPLODE ALL AND CENTRAL:TARGET

15 MESH DESCRIPTOR Abdominal Cavity EXPLODE ALL AND CENTRAL:TARGET

16 MESH DESCRIPTOR Abdominal Wall EXPLODE ALL AND CENTRAL:TARGET

17 ("open abdomen" or "open abdominal" or "abdominal closure") AND CENTRAL:TARGET

18 #12 OR #13 OR #14 OR #15 OR #16 OR #17 AND CENTRAL:TARGET

19 #11 AND #18 AND CENTRAL:TARGET

Trial registry specific search of the Cochrane Central Register of Controlled Clinical Trials (CENTRAL) searched via Cochrane Register
of Studies (appended to CENTRAL search above)

20 (NCT0* or ACTRN* or ChiCTR* or DRKS* or EUCTR* or eudract* or IRCT* or ISRCTN* or JapicCTI* or JPRN* or NTR0* or NTR1* or
NTR2* or NTR3* or NTR4* or NTR5* or NTR6* or NTR7* or NTR8* or NTR9* or SRCTN* or UMIN0*):AU AND CENTRAL:TARGET

21 http*:SO AND CENTRAL:TARGET

22 #20 OR #21

23 #19 AND #22

MEDLINE Ovid

1 exp Negative-Pressure Wound Therapy/

2 exp Suction/

3 exp Vacuum/

4 (negative pressure or negative-pressure or TNP or NPWT or NWPT).tw.

5 (sub-atmospheric or subatmospheric).tw.

6 ((seal* adj surface*) or (seal* adj aspirat*)).tw.

7 (wound adj2 suction*).tw.

8 (wound adj5 drainage).tw.

9 ((foam adj suction) or (suction adj dressing*)).tw.

10 ((vacuum adj therapy) or (vacuum adj dressing*) or (vacuum adj seal*) or (vacuum adj closure) or (vacuum adj assist*) or (vacuum adj
compression) or (vacuum adj pack*) or (vacuum adj drainage) or (suction* adj drainage) or VAC).tw.

11 or/1-10

12 exp Abdomen/su [Surgery]

13 exp Laparotomy/

14 exp Abdominal Injuries/

15 exp Abdominal Cavity/

16 exp Abdominal Wall/

17 (open abdomen or open abdominal or abdominal closure).tw.

18 or/12-17

19 11 and 18

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20 randomized controlled trial.pt.

21 controlled clinical trial.pt.

22 randomized.ab.

23 placebo.ab.

24 drug therapy.fs.

25 randomly.ab.

26 trial.ab.

27 groups.ab.

28 or/20-27

29 exp animals/ not humans.sh.

30 28 not 29

31 19 and 30

Embase Ovid

1 exp vacuum assisted closure/

2 exp Suction/

3 exp Vacuum/

4 (negative pressure or negative-pressure or TNP or NWPT or NPWT).tw.

5 (sub-atmospheric or subatmospheric).tw.

6 ((seal* adj surface*) or (seal* adj aspirat*)).tw.

7 (wound adj2 suction*).tw.

8 (wound adj5 drainage).tw.

9 ((foam adj suction) or (suction adj dressing*)).tw.

10 ((vacuum adj therapy) or (vacuum adj dressing*) or (vacuum adj seal*) or (vacuum adj closure) or (vacuum adj assist*) or (vacuum adj
compression) or (vacuum adj pack*) or (vacuum adj drainage) or (suction* adj drainage) or VAC).tw.

11 or/1-10

12 exp Abdomen/su [Surgery]

13 exp Laparotomy/

14 exp abdominal injury/

15 exp Abdominal Cavity/

16 exp abdominal wall/

17 (open abdomen or open abdominal or abdominal closure).tw.

18 or/12-17

19 11 and 18

20 Randomized controlled trial/

21 Controlled clinical study/

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22 Random$.ti,ab.

23 randomization/

24 intermethod comparison/

25 placebo.ti,ab.

26 (compare or compared or comparison).ti.

27 ((evaluated or evaluate or evaluating or assessed or assess) and (compare or compared or comparing or comparison)).ab.

28 (open adj label).ti,ab.

29 ((double or single or doubly or singly) adj (blind or blinded or blindly)).ti,ab.

30 double blind procedure/

31 parallel group$1.ti,ab.

32 (crossover or cross over).ti,ab.

33 ((assign$ or match or matched or allocation) adj5 (alternate or group$1 orintervention$1 or patient$1 or subject$1 or participant
$1)).ti,ab.

34 (assigned or allocated).ti,ab.

35 (controlled adj7 (study or design or trial)).ti,ab.

36 (volunteer or volunteers).ti,ab.

37 trial.ti.

38 or/20-37

39 (exp animal/ or animal.hw. or nonhuman/) not (exp human/ or human cell/ or (human or humans).ti.)

40 38 not 39

41 19 and 40

CINAHL EBSCO Plus

S42 S18 AND S41

S41 S40 NOT S39

S40 S19 OR S20 OR S21 OR S22 OR S23 OR S24 OR S25 OR S26 OR S27 OR S28 OR S29 OR S30 OR S31 OR S32 OR S33

S39 S37 NOT S38

S38 MH (human)

S37 S34 OR S35 OR S36

S36 TI (animal model*)

S35 MH (animal studies)

S34 MH animals+

S33 AB (cluster W3 RCT)

S32 MH (crossover design) OR MH (comparative studies)

S31 AB (control W5 group)

S30 PT (randomized controlled trial)

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S29 MH (placebos)

S28 MH (sample size) AND AB (assigned OR allocated OR control)

S27 TI (trial)

S26 AB (random*)

S25 TI (randomised OR randomized)

S24 MH cluster sample

S23 MH pretest-posttest design

S22 MH random assignment

S21 MH single-blind studies

S20 MH double-blind studies

S19 MH randomized controlled trials

S18 S11 AND S17

S17 S12 OR S13 OR S14 OR S15 OR S16

S16 TI ( open abdomen or open abdominal or abdominal closure ) or AB ( open abdomen or open abdominal or abdominal closure )

S15 (MH "Abdominal Muscles+")

S14 (MH "Abdominal Injuries+")

S13 (MH "Laparotomy")

S12 (MH "Abdomen+/SU")

S11 S1 OR S2 OR S3 OR S4 OR S5 OR S6 OR S7 OR S8 OR S9 OR S10

S10 TI ( vacuum therapy or vacuum dressing* or vacuum seal* or vacuum closure or vacuum compression or vacuum pack or vacuum
drainage or vacuum assisted or suction drainage or VAC ) OR AB ( vacuum therapy or vacuum dressing* or vacuum seal* or vacuum closure
or vacuum compression or vacuum pack or vacuum drainage or vacuum assisted or suction drainage or VAC )

S9 TI ( foam suction or suction dressing*) OR AB ( foam suction or suction dressing*)

S8 TI (wound N5 drainage) OR AB (wound N5 drainage)

S7 TI (wound N2 suction*) OR AB (wound N2 suction*)

S6 TI ( (seal* N1 surface* or seal* N1 aspirat*) ) OR AB ( (seal* N1 surface* or seal* N1 aspirat*)

S5 TI ( sub-atmospheric or subatmospheric ) OR AB ( sub-atmospheric or subatmospheric )

S4 TI ( negative pressure or negative-pressure or TNP or NPWT or NWPT ) OR AB ( negative pressure or negative-pressure or TNP or NPWT
or NWPT )

S3 (MH "Vacuum")

S2 (MH "Suction+")

S1 (MH "Negative Pressure Wound Therapy")

US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov

negative pressure OR vacuum OR NPWT OR TNP OR VAC | abdomen

negative pressure OR vacuum OR NPWT OR TNP OR VAC | Laparotomy

World Health Organization International Clinical Trials Registry Platform

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(negative pressure OR vacuum OR NPWT OR TNP OR VAC) AND abdomen

(negative pressure OR vacuum OR NPWT OR TNP OR VAC) AND Laparotomy

Appendix 2. Risk of bias assessment (individually randomised controlled trials)

1. Was the allocation sequence randomly generated?
Low risk of bias
The investigators describe a random component in the sequence generation process, such as referring to a random number table; using a
computer random number generator; coin tossing; shuffling cards or envelopes; throwing dice; drawing of lots.

High risk of bias

The investigators describe a non-random component in the sequence generation process. Usually, the description would involve some
systematic, non-random approach, for example, sequence generated by odd or even date of birth; sequence generated by some rule based
on date (or day) of admission; sequence generated by some rule based on hospital or clinic record number.

Unclear risk of bias

Insufficient information about the sequence generation process provided to permit a judgement of low or high risk of bias.

2. Was the treatment allocation adequately concealed?

Low risk of bias
Participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent
method, was used to conceal allocation: central allocation (including telephone, web-based, and pharmacy-controlled randomisation);
sequentially numbered drug containers of identical appearance; sequentially-numbered, opaque, sealed envelopes.

High risk of bias

Participants or investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, such as allocation
based on use of an open random allocation schedule (e.g. a list of random numbers); assignment envelopes without appropriate
safeguards (e.g. envelopes were unsealed, non-opaque, or not sequentially numbered); alternation or rotation; date of birth; case record
number; any other explicitly unconcealed procedure.

Unclear risk of bias

Insufficient information provided to permit a judgement of low or high risk of bias. This is usually the case if the method of concealment
is not described, or not described in sufficient detail to allow a definite judgement, for example, if the use of assignment envelopes is
described, but it remains unclear whether envelopes were sequentially numbered, opaque and sealed.

3. Blinding – was knowledge of the allocated interventions adequately prevented during the study?
Low risk of bias
Any one of the following.

• No blinding, but the review authors judge that the outcome and the outcome measurement are not likely to be influenced by lack of
blinding.
• Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken.
• Either participants or some key study personnel were not blinded, but outcome assessment was blinded and the non-blinding of others
unlikely to introduce bias.

High risk of bias

Any one of the following.

• No blinding or incomplete blinding, and the outcome or outcome measurement is likely to be influenced by lack of blinding.
• Blinding of key study participants and personnel attempted, but likely that the blinding could have been broken.
• Either participants or some key study personnel were not blinded, and the non-blinding of others likely to introduce bias.

Unclear risk of bias

Either of the following.

• Insufficient information to permit judgement of low or high risk of bias.

• The study did not address this outcome.
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4. Were incomplete outcome data adequately addressed?

Low risk of bias
Any one of the following.

• No missing outcome data.

• Reasons for missing outcome data are unlikely to be related to true outcome (for survival data, censoring unlikely to be introducing bias).
• Missing outcome data are balanced in numbers across intervention groups, with similar reasons for missing data across groups.
• For dichotomous outcome data, the proportion of missing outcomes compared with the observed event risk is not enough to have a
clinically relevant impact on the intervention effect estimate.
• For continuous outcome data, a plausible effect size (difference in means or standardised difference in means) among missing outcomes
is not enough to have a clinically relevant impact on the observed effect size.
• Missing data have been imputed using appropriate methods.

High risk of bias

Any one of the following.

• Reason for missing outcome data are likely to be related to the true outcome, with either an imbalance in numbers or reasons for missing
data across intervention groups.
• For dichotomous outcome data, the proportion of missing outcomes compared with the observed event risk is enough to induce
clinically relevant bias in the intervention effect estimate.
• For continuous outcome data, a plausible effect size (difference in means or standardised difference in means) among missing outcomes
is enough to induce a clinically relevant bias in the observed effect size.
• 'As-treated' analysis done with a substantial departure of the intervention received from that assigned at randomisation.
• Potentially inappropriate application of simple imputation.

Unclear risk of bias

Either of the following.

• Insufficient reporting of attrition/exclusions to permit a judgement of low or high risk of bias (e.g. number randomised not stated, no
reasons for missing data provided).
• The study did not address this outcome.

5. Are reports of the study free of suggestion of selective outcome reporting?

Low risk of bias
Either of the following.

• The study protocol is available and all of the study's prespecified (primary and secondary) outcomes that are of interest in the review
have been reported in the prespecified way.
• The study protocol is not available, but it is clear that the published reports include all expected outcomes, including those that were
prespecified (convincing text of this nature may be uncommon).

High risk of bias

Any one of the following.

• Not all of the study's prespecified primary outcomes have been reported.
• One or more primary outcomes is/are reported using measurements, analysis methods, or subsets of the data (e.g. subscales) that were
not prespecified.
• One or more reported primary outcomes was/were not prespecified (unless clear justification for their reporting is provided, such as
an unexpected adverse effect).
• One or more outcomes of interest in the review is/are reported incompletely so that they cannot be entered in a meta-analysis.
• The study report fails to include results for a key outcome that would be expected to have been reported for such a study.

Unclear risk of bias

Insufficient information provided to permit a judgement of low or high risk of bias. It is likely that the majority of studies will fall into this
category.

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6. Other sources of potential bias

Low risk of bias
The study appears free of other sources of bias.

High risk of bias

There is at least one important risk of bias. For example, the study:

• had a potential source of bias related to the specific study design used; or
• has been claimed to have been fraudulent; or
• had some other problem.

Unclear risk of bias

There may be a risk of bias, but there is either:

• insufficient information to assess whether an important risk of bias exists; or

• insufficient rationale or evidence that an identified problem will introduce bias.

HISTORY
Protocol first published: Issue 8, 2020

CONTRIBUTIONS OF AUTHORS
Yao Cheng: designed the review; undertook quality assessment; produced the first draft of the review; performed previous work that was
the foundation of the current review; approved final review prior to submission; is guarantor of the review.

Ke Wang: co-ordinated the review; selected which trials to include; produced the first draft of the review; approved final review prior to
submission.

Junhua Gong: selected which trials to include; extracted data; analysed or interpreted data; performed statistical analysis; contributed to
writing or editing the review; approved final review prior to submission.

Zuojin Liu: conceived the review; extracted data; contributed to writing or editing the review; advised on the review; approved final review
prior to submission.

Jianping Gong: analysed or interpreted data; performed statistical analysis; contributed to writing or editing the review; advised on the
review; approved final review prior to submission.

Zhong Zeng: undertook quality assessment; contributed to writing or editing the review; secured funding; approved final review prior to
submission.

Xiaomei Wang: checked quality of data extraction; checked quality assessment; checked quality of statistical analysis; contributed to
writing or editing the review; wrote to study authors, experts, and companies; approved final review prior to submission.

Contributions of editorial base

Gill Norman (Editor): edited the protocol; advised on methodology, interpretation, and content; approved the final protocol prior to
publication.

Jo Dumville (Joint Co-ordinating Editor): advised on methodology, interpretation, and content; approved the final review prior to
publication.

Gill Rizzello (Managing Editor): co-ordinated the editorial process; advised on interpretation and content; edited the review.

Sophie Bishop (Information Specialist): designed the search strategy; ran the search; and edited the search methods section.

Tom Patterson (Editorial Assistant): wrote the plain language summary and checked the reference sections.

DECLARATIONS OF INTEREST
Yao Cheng: has declared that they have no conflict of interest.
Ke Wang: has declared that they have no conflict of interest.
Junhua Gong: has declared that they have no conflict of interest.
Zuojin Liu: has declared that they have no conflict of interest.
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Jianping Gong: works as a healthcare professional.

Zhong Zeng: works as a healthcare professional.
Xiaomei Wang: works as a healthcare professional.

SOURCES OF SUPPORT

Internal sources
• Chongqing Medical University, Other

This review was supported by the National Natural Science Foundation of China (Grant Nos. 81701950, 82172135), Medical Research
Projects of Chongqing (Grant Nos. 2018MSXM132, 2020FYYZ248), and the Kuanren Talents Program of the second affiliated hospital of
Chongqing Medical University (Grant No. KY2019Y002).

External sources
• The National Institute for Health Research (NIHR), UK

This project was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to Cochrane Wounds. The
views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.

DIFFERENCES BETWEEN PROTOCOL AND REVIEW

• We updated our search terms by adding intervention terms that retrieved additional relevant results.
• We did not perform any subgroup analyses because there was an insufficient number of studies included in the review.
• We did not perform funnel plots to assess reporting biases because there were fewer than 10 included studies.
• We added size of the wound to Data extraction and management.

INDEX TERMS

Medical Subject Headings (MeSH)

Abdomen; *Negative-Pressure Wound Therapy [methods]; Pain; Randomized Controlled Trials as Topic; Wound Healing; *Wound
Infection

MeSH check words

Adult; Female; Humans; Middle Aged

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