Exudate management with a next-generation multilayered foam dressing in traumatic and surgical wounds: a prospective, multicentre study

OBJECTIVE: The aim of this study was to evaluate the efficacy, performance and safety of ConvaFoam (Convatec Ltd., UK), a next-generation multilayered foam dressing, in indicated surgical and traumatic wounds. METHOD: This prospective, multicentre, open-label study (ClinicalTrials.gov: NCT05632276) evaluated ConvaFoam dressings in surgical and traumatic wounds. Eligible patients were managed with ConvaFoam dressings in accordance with their instructions for use (maximum seven-day wear time) for ≤4 weeks. The primary endpoint was the proportion of patients and total dressings with excellent exudate management (defined as absence of strikethrough or periwound maceration). Secondary endpoints included: exudate management in dressings worn for seven days; healing rate; wear time; pain on application; usability; and safety. RESULTS: The study enrolled 52 patients (mean age: 48.2 years) with surgical (54%) or traumatic (46%) wounds. Median dressing wear time was five days (interquartile range: 1-7 days). Among patients who completed the study, 81% (38/47) were observed to have achieved excellent exudate management throughout all wound care visits (90% confidence interval (CI): 71, 90%). Excellent exudate management was also observed in 93% (209/224) of total dressings applied (90% CI: 90, 97%), including in 96% (47/49) of dressings worn for seven days. Only one patient in the study experienced periwound skin maceration at any study timepoint. Wound healing was observed in 93% of surgical wounds and 25% of traumatic wounds during the study period. Low levels of pain and high user satisfaction as per numeric pain scale and utility questionnaire, respectively, were reported. CONCLUSION: ConvaFoam dressings demonstrated excellent exudate management in >90% of dressing changes, and may promote an optimal environment for healing in surgical and traumatic wounds.