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A randomised,controlled, non‐inferiority trial comparing the performance of a soft silicone‐coated wound contact layer (Mepitel One) with a lipidocolloid wound contact layer (UrgoTul) in the treatment of acute wounds
Authors:Franck David  Jean‐Louis Wurtz  Nicolas Breton  Olivier Bisch  Philippe Gazeu  Jean‐Charles Kerihuel  Odile Guibon
Affiliation:1. Verzy France ; 2. ResearchLink France, Mundolsheim France ; 3. ResearchLink France, Béziers France ; 4. ResearchLink France, Bischheim France ; 5. Mauguio France ; 6. Vertical, Paris France ; 7. Medical Affairs Department, Mölnlycke Health Care, Wasquehal France
Abstract:Wound contact layer (WCL) dressings are intended to protect tissue during the healing process. A randomised controlled trial was undertaken to compare 2 such dressings. Outpatients with acute wounds were randomly allocated to treatment with either a soft silicone‐coated WCL (intervention group, n = 59) or a lipidocolloid‐impregnated WCL (control group, n = 62). At the first dressing removal (day 3), 89.8% of patients in the intervention group experienced non‐painful dressing removal (defined as a pain rating <30 mm on a 100 mm visual analogue scale), compared with 73.6% of patients in the control group (P = .017) (per protocol population). At day 21, wounds were considered as healed in 66.1% of patients in the intervention group compared with 43.5% in the control group (P = .012) (intention‐to‐treat population). Both dressings were well tolerated and rated highly in terms of in‐use characteristics, although the soft silicone‐coated WCL was rated significantly higher than the lipidocolloid‐impregnated WCL in terms of its ability to remain in place (P= .016). The results indicate that the soft silicone‐coated WCL is suitable for the management of acute wounds as it can minimise dressing‐associated pain and support healing.
Keywords:acute wound  burn  randomised controlled trial  traumatic wound  wound dressing‐associated pain
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