Open AccessA randomised controlled 8‐week crossover clinical evaluation of the 3M™ Coban™ 2 Layer Compression System versus Profore™ to evaluate the product performance in patients with venous leg ulcers
Author(s) -
Moffatt Christine J,
Edwards Lynfa,
Collier Mark,
Treadwell Terry,
Miller Michael,
Shafer Laura,
Sibbald Gary,
Brassard Alain,
McIntosh Andrea,
Reyzelman Alex,
Price Patricia,
Kraus Stacia Merkel,
Walters ShelleyAnn,
Harding Keith
Publication year - 2008
Publication title -
international wound journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.867
H-Index - 63
eISSN - 1742-481X
pISSN - 1742-4801
DOI - 10.1111/j.1742-481x.2008.00487.x
Subject(s) - medicine , wilcoxon signed rank test , bandage , compression bandage , clinical endpoint , crossover study , exact test , venous leg ulcer , surgery , randomized controlled trial , physical therapy , mann–whitney u test , pathology , placebo , alternative medicine
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 < 0·05). Patients had a strong preference for the two‐layer system (72%) than the four‐layer system (22%), with 6% having no preference. In conclusion, the two‐layer system exhibited significantly less bandage slippage than the four‐layer system. While less bandage slippage did not appear to impact wound healing, there was indication that it may have influenced patient preference in favour of the two‐layer system and potentially impacted patients’ HRQoL.