Biological Skin Substitutes in Pressure Ulcers: High-Purity Type I Collagen-Based Versus Amnion/Chorion Membrane

Background: Pressure ulcers (PUs) present a therapeutic challenge in bedridden or neurologically impaired patients and represent a significant healthcare burden, affecting millions of patients worldwide. Current standard treatment approaches often fall short in achieving optimal healing outcomes, necessitating the development of advanced therapeutic interventions. Biological skin substitutes - high‐purity type I collagen (HPTC) and dehydrated human amnion/chorion membrane (dHACM) - have emerged as promising therapeutic alternatives to traditional wound care approaches. This study compares their effectiveness in treating stage III-IV PUs. Methods: This prospective, randomized, controlled, open-label, two parallel group, single-centre clinical trial was conducted at Adichunchanagiri Institute of Medical Sciences, a tertiary care hospital in India, specializing in wound care and reconstructive surgery. We conducted a parallel group, open-label, randomized controlled trial with 80 patients (n = 40 per group) with stage III or IV PUs randomized 1:1 to receive either HPTC (Helicoll®) or dHACM, applied alongside standard wound care. The primary endpoint was complete ulcer closure by seven weeks, including a one-week follow-up. Secondary outcomes included time to closure, vascularity infiltration, reduction in wound area, number of repeated applications, adverse events, scar improvement, structural stability, and patient satisfaction. Statistical analysis was performed using appropriate parametric and non-parametric tests. Results: The HPTC group demonstrated superior outcomes with 30 patients (75%) having complete wound closure compared to 25 patients (62.5%) in the dHACM group (p = 0.234). Mean percentage wound closure was 78.5% ± 18.2% for HPTC versus 65.1% ± 9.8% for dHACM (p < 0.05). HPTC showed enhanced vascular infiltration (Grade 3: 31 patients (77.5%) vs. eight patients (20%) (p < 0.001)), improved neo-epithelialization (Grade 3: 28 patients (70%) vs. nine patients (22.5%) (p < 0.001)), and increased fibroblast activity (Grade 3: 33 patients (82.5%) vs. seven patients (17.5%) (p < 0.001)) at day 5. The HPTC group required fewer reapplications (0.85 ± 0.92 vs. 1.15 ± 0.87, p = 0.127). No serious adverse events were reported in either group. Adverse events were minor and similar between groups. The HPTC group demonstrated superior outcomes with 29 patients (72.5%) showing improved patient satisfaction compared to 17 patients (42.5%) in the dHACM group. Conclusion: Helicoll® (HPTC) showed numerically superior healing rates, improved tissue regeneration parameters, required fewer reapplications with better structural stability of the healed wound, improved patient satisfaction outcomes compared to dHACM, suggesting potential clinical and economic advantages. These findings support the use of Helicoll® as an effective therapeutic option for PU management.