Use of a next-generation multilayered foam dressing in hard-to-heal wounds: a prospective, multicentre study.

Abstract

Objective: Hard-to-heal wounds present a significant healthcare challenge due to their complex aetiology, impact on quality of life (QoL) and consequent economic burden. The aim of this study was to assess the usability, safety and performance of a next-generation, multilayered foam dressing, ConvaFoam (Convatec Ltd., UK), in the management of indicated hard-to-heal wounds.

Method: In this prospective, multicentre, interventional, non-comparator, open-label study, wounds included venous leg ulcers, arterial leg ulcers, diabetic foot ulcers and pressure injuries. The primary endpoint was percentage change in wound area at four weeks. Additional endpoints included percentage change in wound area at 12 weeks, satisfactory clinical progress (defined as ≥40% reduction in study wound area at four weeks), complete wound closure, adverse events, pain, QoL and health professional usability outcomes.

Results: A total of 90 patients (109 wounds) were included in the full analysis set. The median percentage reduction in wound area from baseline was 47.88% (p<0.0001) at week 4 and 93.75% (p<0.0001) at week 12. Satisfactory clinical progress at four weeks was reported for 61 (55.96%) wounds. Complete wound closure by week 12 was observed in 43 (39.45%) wounds (p<0.0001). The median Wound Quality of Life-14 score improved from 55.36 at baseline, to 80.36 at week 12. Of the 2935 dressing applications, there were only two adverse events which were reported to be related to the study dressings. The majority of health professionals rated ease of application, exudate management, ease of removal and conformity as excellent.

Conclusion: The ConvaFoam dressings were shown to be effective at reducing wound size and promoting healing in indicated hard-to-heal wounds, particularly diabetic foot and venous ulcers.