title: A 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.
abstract: 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.
authors.affiliation: Centre for Research and Implementation of Clinical Practice, Thames Valley University, 32-8 Uxbridge Road, London, UK.
authors.forename: Christine J
authors.initials: CJ
authors.lastname: Moffatt
authors.forename: Lynfa
authors.initials: L
authors.lastname: Edwards
authors.forename: Mark
authors.initials: M
authors.lastname: Collier
authors.forename: Terry
authors.initials: T
authors.lastname: Treadwell
authors.forename: Michael
authors.initials: M
authors.lastname: Miller
authors.forename: Laura
authors.initials: L
authors.lastname: Shafer
authors.forename: Gary
authors.initials: G
authors.lastname: Sibbald
authors.forename: Alain
authors.initials: A
authors.lastname: Brassard
authors.forename: Andrea
authors.initials: A
authors.lastname: McIntosh
authors.forename: Alex
authors.initials: A
authors.lastname: Reyzelman
authors.forename: Patricia
authors.initials: P
authors.lastname: Price
authors.forename: Stacia Merkel
authors.initials: SM
authors.lastname: Kraus
authors.forename: Shelley-Ann
authors.initials: SA
authors.lastname: Walters
authors.forename: Keith
authors.initials: K
authors.lastname: Harding
mesh_terms: D000368:Aged; D015331:Cohort Studies; D018592:Cross-Over Studies; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011788:Quality of Life; D053828:Stockings, Compression; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000628:therapy*; D014945:Wound Healing