This article is an abstract from a new guide, Principles of Best Practice: Minimising Pain at Wou... more This article is an abstract from a new guide, Principles of Best Practice: Minimising Pain at Wound Dressing-Related Procedures. It is an educational initiative of the World Union of Wound Healing Societies (WUWHS). The guide has been inspired by two seminal documents: the European Wound Management Association's position document, Pain at Wound Dressing Changes (EWMA, 2002), and Practical Treatment of Wound Pain and Trauma: A Patient-centred Approach (Reddy et al, 2003). As an international educational initiative, the WUWHS document is aimed at anyone involved in dressing-related procedures anywhere in the world. This article summarises the section on best practice in the assessment of wound pain.
Topically applied recombinant human platelet-derived growth factor-BB (becaplermin) is a new phar... more Topically applied recombinant human platelet-derived growth factor-BB (becaplermin) is a new pharmacologically active therapy for chronic, neuropathic, lower extremity diabetic ulcers. In previous studies, becaplermin gel was administered once daily but dressings were changed twice daily. In the present study of 134 patients with diabetes mellitus and full thickness lower extremity ulcers, dressings were changed only once per day, simplifying the treatment regimen. Efficacy criteria included the percentage of patients achieving complete healing within the 20-week treatment period, the time to achieve complete healing, the rate of ulcer recurrence during the 6-month period following healing, and treatment compliance. Complete healing of ulcers was achieved in 57. 5% of patients, with a mean time to closure of 63 days and a recurrence rate of 21% at 6 months. Of the potential factors affecting ulcer healing, only drug compliance (p < 0.001), dressing compliance (p < 0.01), the presence of infection (p < 0.01), baseline ulcer area (p < 0.05), and baseline total wound evaluation score (p < 0.05) were significantly associated with healing. Results of this study further confirm the efficacy and safety of becaplermin gel for the treatment of lower extremity diabetic ulcers.
... Tip the SCALE toward quality end-of-life skin care. Sibbald, Gary R. BSc, MD, MEd, FRCPC (Med... more ... Tip the SCALE toward quality end-of-life skin care. Sibbald, Gary R. BSc, MD, MEd, FRCPC (Med Derm), MACP, FAAD, FAPWCA; Krasner, Diane L. PhD, RN, CWCN, CWS, BCLNC, FAAN; Lutz, James MS, CCRA. Continued Education. Article Outline. Collapse Box ...
Journal of the American Academy of Dermatology, 1997
Background." Onychomycosis is an increasing problem with limited therapeutic options. Objective: ... more Background." Onychomycosis is an increasing problem with limited therapeutic options. Objective: We evaluated the safety and efficacy of oral terbinafine, a new fungicidal antimycotic, in patients with toenail onychomycosis.
Pain is a common concern in patients with chronic wounds. The purpose of this article is to infor... more Pain is a common concern in patients with chronic wounds. The purpose of this article is to inform clinicians of empirical evidence for practice based on a recent published consensus document on wound related pain. A team approach is needed to address the experience of living with wound related pain within a holistic framework. The importance of regular pain assessment and strategies to minimize traumatic during wound care are highlighted.
This study compared a two-layer (Coban 2 Layer) and a four-layer (Profore) compression bandage sy... more This study compared a two-layer (Coban 2 Layer) and a four-layer (Profore) compression bandage system in venous leg ulcer patients. Participants (n = 81) were enrolled into an 8-week, randomised, open-label, ten-centre, crossover clinical trial. The primary endpoint was bandage slippage measured at each dressing change. Secondary endpoints included wound healing, health-related quality of life (HRQoL) and patient preference. Mean slippage estimated from a mixed analysis of variance model (697 visits) was 2.48 cm for the two-layer system and 4.17 cm for the four-layer system (P < 0.001). There were no significant differences in percent of wounds that healed (Fisher's exact test, P = 0.30), in wound area reduction (Wilcoxon rank-sum test, P = 0.88) or in linear healing rate (Wilcoxon rank-sum test, P = 0.94). The HRQoL Physical Symptoms and Daily Living scores were significantly higher with the two-layer system (pooled two-sample t-test, P…
Persistent (chronic) wound-related pain is a common experience that requires appropriate assessme... more Persistent (chronic) wound-related pain is a common experience that requires appropriate assessment and treatment. It is no longer adequate for health care professionals to concentrate on the acute (temporary) pain during dressing change alone. The study provides useful recommendations and statements for assessing and managing total wound-related pain for patients, health care professionals and other policymakers. The recommendations have been developed with the involvement of an interprofessional panel of health care professionals from around the world.
Regulatory requirements for new products should be guided by clinical trials that protect the pub... more Regulatory requirements for new products should be guided by clinical trials that protect the public by a thorough evaluation of safety and efficacy, while not creating unnecessary barriers to their development and ultimate approval. While healing a wound is the ultimate goal of treating an individual with a diabetic foot ulcer, achieving this goal is physiologically complex requiring the initiation and interaction of many events and therefore unlikely to be achieved by one compound. We believe that developing new, more meaningful, study outcomes or end points in wound care trials would both aid in determining the true efficacy of wound management modalities and facilitate the product development cycle. The primary guidance from the US Food and Drug Administration to industry in this field was published in 2006. This document, while helpful and largely in concert with current knowledge of wound healing, needs to be substantially improved. We therefore convened an interdisciplinary task force comprising experts in various aspects of wound care to attempt to achieve consensus in defining primary outcomes and potential secondary endpoints for various classes of wound-healing modalities.
This article is an abstract from a new guide, Principles of Best Practice: Minimising Pain at Wou... more This article is an abstract from a new guide, Principles of Best Practice: Minimising Pain at Wound Dressing-Related Procedures. It is an educational initiative of the World Union of Wound Healing Societies (WUWHS). The guide has been inspired by two seminal documents: the European Wound Management Association's position document, Pain at Wound Dressing Changes (EWMA, 2002), and Practical Treatment of Wound Pain and Trauma: A Patient-centred Approach (Reddy et al, 2003). As an international educational initiative, the WUWHS document is aimed at anyone involved in dressing-related procedures anywhere in the world. This article summarises the section on best practice in the assessment of wound pain.
Topically applied recombinant human platelet-derived growth factor-BB (becaplermin) is a new phar... more Topically applied recombinant human platelet-derived growth factor-BB (becaplermin) is a new pharmacologically active therapy for chronic, neuropathic, lower extremity diabetic ulcers. In previous studies, becaplermin gel was administered once daily but dressings were changed twice daily. In the present study of 134 patients with diabetes mellitus and full thickness lower extremity ulcers, dressings were changed only once per day, simplifying the treatment regimen. Efficacy criteria included the percentage of patients achieving complete healing within the 20-week treatment period, the time to achieve complete healing, the rate of ulcer recurrence during the 6-month period following healing, and treatment compliance. Complete healing of ulcers was achieved in 57. 5% of patients, with a mean time to closure of 63 days and a recurrence rate of 21% at 6 months. Of the potential factors affecting ulcer healing, only drug compliance (p < 0.001), dressing compliance (p < 0.01), the presence of infection (p < 0.01), baseline ulcer area (p < 0.05), and baseline total wound evaluation score (p < 0.05) were significantly associated with healing. Results of this study further confirm the efficacy and safety of becaplermin gel for the treatment of lower extremity diabetic ulcers.
... Tip the SCALE toward quality end-of-life skin care. Sibbald, Gary R. BSc, MD, MEd, FRCPC (Med... more ... Tip the SCALE toward quality end-of-life skin care. Sibbald, Gary R. BSc, MD, MEd, FRCPC (Med Derm), MACP, FAAD, FAPWCA; Krasner, Diane L. PhD, RN, CWCN, CWS, BCLNC, FAAN; Lutz, James MS, CCRA. Continued Education. Article Outline. Collapse Box ...
Journal of the American Academy of Dermatology, 1997
Background." Onychomycosis is an increasing problem with limited therapeutic options. Objective: ... more Background." Onychomycosis is an increasing problem with limited therapeutic options. Objective: We evaluated the safety and efficacy of oral terbinafine, a new fungicidal antimycotic, in patients with toenail onychomycosis.
Pain is a common concern in patients with chronic wounds. The purpose of this article is to infor... more Pain is a common concern in patients with chronic wounds. The purpose of this article is to inform clinicians of empirical evidence for practice based on a recent published consensus document on wound related pain. A team approach is needed to address the experience of living with wound related pain within a holistic framework. The importance of regular pain assessment and strategies to minimize traumatic during wound care are highlighted.
This study compared a two-layer (Coban 2 Layer) and a four-layer (Profore) compression bandage sy... more This study compared a two-layer (Coban 2 Layer) and a four-layer (Profore) compression bandage system in venous leg ulcer patients. Participants (n = 81) were enrolled into an 8-week, randomised, open-label, ten-centre, crossover clinical trial. The primary endpoint was bandage slippage measured at each dressing change. Secondary endpoints included wound healing, health-related quality of life (HRQoL) and patient preference. Mean slippage estimated from a mixed analysis of variance model (697 visits) was 2.48 cm for the two-layer system and 4.17 cm for the four-layer system (P < 0.001). There were no significant differences in percent of wounds that healed (Fisher's exact test, P = 0.30), in wound area reduction (Wilcoxon rank-sum test, P = 0.88) or in linear healing rate (Wilcoxon rank-sum test, P = 0.94). The HRQoL Physical Symptoms and Daily Living scores were significantly higher with the two-layer system (pooled two-sample t-test, P…
Persistent (chronic) wound-related pain is a common experience that requires appropriate assessme... more Persistent (chronic) wound-related pain is a common experience that requires appropriate assessment and treatment. It is no longer adequate for health care professionals to concentrate on the acute (temporary) pain during dressing change alone. The study provides useful recommendations and statements for assessing and managing total wound-related pain for patients, health care professionals and other policymakers. The recommendations have been developed with the involvement of an interprofessional panel of health care professionals from around the world.
Regulatory requirements for new products should be guided by clinical trials that protect the pub... more Regulatory requirements for new products should be guided by clinical trials that protect the public by a thorough evaluation of safety and efficacy, while not creating unnecessary barriers to their development and ultimate approval. While healing a wound is the ultimate goal of treating an individual with a diabetic foot ulcer, achieving this goal is physiologically complex requiring the initiation and interaction of many events and therefore unlikely to be achieved by one compound. We believe that developing new, more meaningful, study outcomes or end points in wound care trials would both aid in determining the true efficacy of wound management modalities and facilitate the product development cycle. The primary guidance from the US Food and Drug Administration to industry in this field was published in 2006. This document, while helpful and largely in concert with current knowledge of wound healing, needs to be substantially improved. We therefore convened an interdisciplinary task force comprising experts in various aspects of wound care to attempt to achieve consensus in defining primary outcomes and potential secondary endpoints for various classes of wound-healing modalities.
Uploads
Papers by Gary Sibbald