J Comp Eff Res · 2021
A prospective, randomized, controlled, crossover study comparing three multilayered foam dressings for the management of chronic wounds
Alvarez, O.M., Granick, M.S., Reyzelman, A., & Serena, T.
Journal of Comparative Effectiveness Research (Future Medicine)
In brief
This randomized, controlled crossover trial at three US outpatient centers compared three silicone-bordered foam dressings (Mepilex Border Flex versus Allevyn Life, and Mepilex Border Flex versus Optifoam Gentle EX) in 41 adults with venous leg ulcers or diabetic foot ulcers, with dressing durability (leakage of exudate, called strikethrough) as the primary endpoint. In week 1, more Mepilex Border Flex dressings stayed intact to day 7 than Allevyn Life (35.3% vs 5.6%, p < 0.05) and Optifoam Gentle EX (43.8% vs 12.5%, p = 0.01), differences that were statistically significant, while wound size reduction did not differ significantly between dressings. No serious or device-related adverse events were reported; the study was small and open label and was sponsored by the maker of Mepilex Border Flex.
A SerenaGroup research center took part in this trial.
Plain-language summary by SerenaGroup. See the full text for complete methods and results.
Abstract
Compare foam dressings – Mepilex Border Flex (MxBF), Allevyn Life (AL) and Optifoam Gentle EX (OGEX) – in treatment of chronic wounds. Materials & methods: Prospective, randomized, controlled trial (crossover design). Subjects received one dressing for 2 weeks, then comparator dressing for following 2 weeks. Wound/periwound characteristics evaluated weekly at dressing change. Primary end point: dressing durability (incidence of exudate strikethrough). Results: Higher incidence of intact dressings (no strikethrough) at Day 7 (Week 1) with MxBF (6/17; 35.3%) compared with AL (1/18; 5.6%), and with MxBF (7/16; 43.8%) compared with OGEX (2/16; 12.5%; p < 0.05). No significant differences between groups regarding wound size reduction. Conclusion: MxBF had statistically greater durability than AL/OGEX during first critical week of treatment. First draft submitted: 3 December 2020; Accepted for publication: 29 January 2021; Published online: 19 February 2021
Keywords
chronic wounddressing durabilitymedical devicesrandomized controlled trialssilicone-bordered foam dressingswound dressings
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