Publication (translated from original German): Effectiveness of an Acellular Synthetic Matrix as an Adjunct to Standard Care in Venous and Mixed Leg Ulcers: Comparison of Clinical Study Data and Routine Data

Objectives: To assess the effectiveness of a new acellular synthetic matrix (ASM) as an adjunct to standard care, using healing time as endpoint in the treatment of chronic venous and mixed leg ulcers in German everyday clinical practice. Patients and methods: Prospective data on chronic, vascular leg ulcers from a safety and effectiveness study on an ASM was compared retrospectively to matched data from a German Registry of Chronic Wounds (DRCW) database containing patients with equivalent ulcer disease, patient age and gender, baseline wound area, wound duration, same outcome measures, and comparable follow-up periods. The primary outcome was healing time over around 12-weeks of treatment. Results: Analysis using Kaplan-Meier curves showed a mean of 73.1 days (95% CI: 66.4-79.9 days) to healing for ASM treated ulcers (n = 53), in comparison to 85.1 days (95% CI: 80.5-89.6 days) for equivalent ulcers (n = 64) of DRCW treated in German everyday clinical practice. Discussion: Results from this study predict a highly significant effect of a new ASM as an adjunct to standard care in the repair of chronic venous and mixed leg ulcers. The predictive model may be useful in determining expected effectiveness of the ASM in the treatment of chronic venous and mixed leg ulcer patients treated in German everyday clinical practice.