Abstract
BACKGROUND: Full-thickness wounds are a significant clinical burden, especially in patients with chronic comorbidities. They pose a major clinical challenge due to their prolonged healing times and high risk of complications. Advanced wound care strategies like negative-pressure wound therapy (NPWT), which enhances wound healing by reducing edema, promoting granulation tissue formation, and removing exudates and bioengineered skin substitutes such as high-purity type I collagen-based skin substitute (HPTC/Helicoll(®)) that acts as an extracellular matrix scaffold to stimulate angiogenesis and cellular proliferation, have emerged as promising interventions. This study evaluates the comparative effectiveness of NPWT combined with HPTC versus NPWT alone in promoting wound healing in full-thickness wounds. METHODS: This was a prospective, randomized, open-label, parallel-group clinical trial conducted at the Department of Plastic, Reconstructive, and Aesthetic Surgery, Adichunchanagiri Institute of Medical Sciences (AIMS), Karnataka, India. This study enrolled 104 patients with full-thickness wounds, randomly allocated into two groups: Group A received NPWT combined with HPTC (n = 52), and Group B received NPWT alone (n = 52). The primary outcome was percentage wound area reduction at seven weeks, while secondary outcomes included time to complete epithelialization, proportion achieving complete closure, vascularity infiltration on histology, pain assessment using the Visual Analog Scale (VAS), quality of life (QoL) outcome using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire, and scar assessment using Vancouver Scar Scale (VSS) scores. Statistical analysis included Student's t-test, Chi-square test, and Kaplan-Meier survival analysis. RESULTS: Group A showed significantly higher mean wound size reduction (p < 0.01) at seven weeks, with Group A demonstrating a reduction of 89.35% ± 16.08 and Group B showing 57.85% ± 12.73 reduction, with p value <0.001 (highly significant). Complete healing was achieved in 45 patients (86.54%) of Group A compared to 22 patients (42.31%) of Group B by seven weeks, being statistically highly significant (p-value < 0.001). Mean time to wound closure was shorter in Group A (36.81 ± 12.88 days) than in Group B (43.94 ± 16.70 days), showing a statistically superior closure rate. Pain scores on the VAS, QoL Assessment using EQ-5D-5L, and scar assessment using the VSS were also significantly in favor of the combination group compared to the NPWT-alone group. CONCLUSION: The combination of NPWT with HPTC skin substitute (Helicoll(®)) significantly accelerates wound healing and faster closure, improves histopathological parameters, and has better scar outcomes in full-thickness wounds compared to NPWT alone. These findings support incorporating HPTC-based skin substitutes in complex wound care protocols, and this combination therapy represents a promising advancement in wound management.