Objective: To evaluate the safety and performance of MedicelTulle Dressing (MTD) in subjects with chronic or acute wounds left to heal by secondary intention.
Method: This 28-day, multi-centre, single-arm clinical study was conducted at seven sites in France. Thirty patients with a chronic (n = 20) or acute wound (n = 10) were treated with MTD and gauze as a secondary dressing. Study treatment lasted 28 days or until healing.
Results: Mean baseline wound area was 14.8cm2. There were 103 clinic dressing changes and 220 home dressing changes. Seven adverse events were reported in five subjects, including one treatment-related adverse event of dry scab. No adherence was reported for 66% of clinic dressing changes and 53% of home dressing changes. No trauma was reported for 96% of clinic dressing changes. Mean reduction in wound size was 7.0cm2.
Conclusion: In this study, MTD demonstrated good safety results. Additional study is warranted to confirm the clinical utility of MTD in the management of chronic or acute wounds left to heal by secondary intention.