Non-interventional study to investigate the efficacy and safety of Tegaderm™ Matrix in the treatment of patients with therapy-refractory chronic wounds

Abstract

Background: Despite a variety of therapeutic approaches, many patients with chronic wounds remain refractory to treatment. Products such as Tegaderm™ Matrix were developed especially for such patients to alter the wound environment and reactivate the stagnant wound healing process.

Patients and methods: In this prospective post-authorization observational product study, a total of 314 patients with therapy-refractory chronic wounds of various origins were evaluated. Beside to the wound area reduction and healing rate, the occurrence of adverse events was documented.

Results: On average the wounds were 10 months old. The average wound size was 17.3 cm(2) (median 6.3 cm(2)) at the initial visit. In the course of treatment the wound size decreased to 13.0 cm(2) (median 3.5 cm(2)) and was finally reduced to 9.3 cm(2) (median 0.9 cm(2)) at end of the study. Taking the criteria of the European Wound Management Association for improving the quality of clinical studies into consideration, a wound size reduction of at least 50% is the parameter for successful treatment of chronic wounds. This study demonstrated a wound size reduction of at least 50% for 72.9% of the patients with therapy-refractory chronic wounds when treated with Tegaderm™ Matrix. The safety profile was evaluated; only 4.7% of the patients experienced a treatment-related adverse event such as a burning sensation.

Conclusions: The results of the study demonstrate that Tegaderm™ Matrix along with treatment of underlying causes is a well tolerated wound dressing promoting wound size reduction up to healing for the majority of patients with previously therapy-refractory chronic wounds.