Cellulose biomembranes may be used for difficult-to-treat
ulcers. To assess the efficacy and safety of
cellulose biomembranes compared to a
collagenase dressing for the treatment of chronic
venous ulcers. A randomized, controlled clinical trial was performed using two groups: one treated with
collagenase dressing and the other with
cellulose biomembrane over a 90-day (T90) period. Both groups received compression
therapy. The primary outcome was reduction in
ulcer area at T90. Secondary outcomes were healing status, decrease in devitalized tissue and exudate, vascular fraction, change in quality of life, and safety. We randomized 46 participants with 73
venous ulcers (21 with 36
ulcers in the
collagenase group and 25 with 37
ulcers in the biomembrane group). A decrease in
ulcer area occurred at T90 in both groups, but the difference was not significant. Complete healing before T90 occurred for seven
ulcers in the
collagenase group and 12
ulcers in the biomembrane group, without significant difference. However, the biomembrane promoted increased precocious healing (p = 0.02). Improved bed vitality and quality of life was observed as a function of time (p < 0.01), but this was not significant between the groups. Immunohistochemical analysis of CD34 showed an increase in vascular fraction in both groups (p < 0.01), with a higher level in the biomembrane group (p < 0.05). No adverse events were considered related to the products.
Cellulose biomembranes, in combination with compressive
therapy, are effective and safe for the treatment of
venous ulcers and provide results similar to those with
collagenase treatment.