Collagen sponge combined with recombinant human basic fibroblast growth factor for refractory venous leg ulcers: A prospective controlled study evaluating healing, skin graft avoidance, and costs.

Abstract

Refractory venous leg ulcers (VLUs) represent a significant clinical challenge, often requiring surgical intervention with skin grafting. This study evaluated whether a collagen sponge combined with recombinant human basic fibroblast growth factor (rh-bFGF) could accelerate healing, reduce the need for skin grafting, lower costs, and improve scar quality compared with standard alginate dressings. This prospective controlled study enrolled 120 patients with CEAP C6 VLUs refractory to standard compression therapy. Patients were allocated to treatment with either a collagen sponge saturated with rh-bFGF (n = 60) or standard alginate dressing (n = 60), both under compression therapy. The primary endpoint was complete wound healing at 4 weeks. Secondary endpoints included time-to-healing (analyzed by Kaplan-Meier with log-rank test), need for skin grafting, total hospitalization costs, and scar quality assessed by the Vancouver Scar Scale (VSS) at 3 months. Multivariable Cox regression was used to adjust for potential confounders. The CS + rh-bFGF group achieved a significantly higher 4-week healing rate (85.0% vs. 55.0%; risk difference: 30.0%, 95% CI: 15.2-44.8; p < 0.001). Median healing time was shorter in the treatment group (26 days vs. 44 days; log-rank p < 0.001), with an adjusted hazard ratio of 2.54 (95% CI: 1.71-3.78). No patient in the treatment group required skin grafting compared with 13 patients (21.7%) in the control group (p < 0.001). Total hospitalization costs were lower in the treatment group (¥14,850 ± 2420 vs. ¥22,160 ± 4150; mean difference: ¥7310, 95% CI: ¥5890-¥8730; p < 0.001). Scar quality was superior in the treatment group (VSS: 3.6 ± 1.1 vs. 5.8 ± 1.5; mean difference: 2.2, 95% CI: 1.7-2.7; p < 0.001). Adverse event rates were comparable between groups (6.7% vs. 10.0%, p = 0.512). In this prospective controlled study of 120 patients with refractory VLUs, the combination of a collagen sponge and rh-bFGF was associated with faster healing, elimination of skin grafting, reduced hospitalization costs, and superior scar quality compared with standard alginate dressings. These findings suggest that this approach warrants evaluation in randomized controlled trials to establish its role in clinical practice.