Efficacy and performance of a next-generation advanced multi-layered foam dressing indicated for hard-to-heal wounds – a prospective, multicenter study

Introduction: Hard-to-heal wounds present a significant healthcare challenge, due to their complex etiology, impact on health-related quality of life, and large economic burden.1 The global prevalence of hard-to-heal wounds has been estimated as 2.21 per 1000 population, and is predicted to increase with the ageing population.2 The standard of care in treatment of hard-to-heal wounds involves the application of wound dressings to manage excess exudate and provide a moist environment to promote wound healing. The aim of this study was to assess the efficacy and performance of a next-generation advanced multi-layered foam dressing* in the management of hard-to-heal wounds.Methods:A prospective, multicenter, interventional, non-comparator, open-label study of hard-to-heal wounds, managed with either a border, silicone or non-adhesive version of a next-generation advanced multi-layered foam dressing.* The primary endpoint was percentage change in wound size from baseline to 4 weeks post-dressing application. The secondary endpoints were satisfactory clinical progression defined as 40% reduction in study wound area at 4 weeks post-dressing application. Results:Ninety-two patients with 111 wounds were enrolled in the study (mean patient age, 66.0 years). Venous (mixed) ulcers were the most common wounds reported in the study (n=64; 57.7%). In addition, the study population included 34 diabetic foot ulcers (30.6%), 10 pressure injuries (9.0%), and 3 arterial ulcers (2.7%). Of the 92 patients enrolled, 73 completed the study (number of wounds, n=109). At week 4, the median percentage wound area of change from baseline was 47.9% (p