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.
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.
Moffatt
Christine J
CJ
Centre for Research and Implementation of Clinical Practice, Thames Valley University, 32-8 Uxbridge Road, London, UK.
Edwards
Lynfa
L
Collier
Mark
M
Treadwell
Terry
T
Miller
Michael
M
Shafer
Laura
L
Sibbald
Gary
G
Brassard
Alain
A
McIntosh
Andrea
A
Reyzelman
Alex
A
Price
Patricia
P
Kraus
Stacia Merkel
SM
Walters
Shelley-Ann
SA
Harding
Keith
K
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