Clinical Trial

Prospective Clinical Evaluation of High-Purity Type I Collagen in Select High-Risk Hernia Repair Scenarios

Completed
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Summary
This prospective, single-arm clinical study evaluates the safety, feasibility, and early clinical outcomes of High-Purity Type I Collagen (HPTC; Surgicoll-Mesh®) when used as a biologic reinforcement in selected hernia repair scenarios where permanent synthetic mesh placement is undesirable. Outcomes focus on early postoperative safety, wound healing, and complication profiles over an 8-week follow-up period.
Protocol Amendment History 3 changes
critical Trial completed 2026-04-24
critical Primary endpoint(s) modified 2026-04-24
notable Enrollment increased: 25 -> 30 participants 2026-04-24
Trial Details
NCT Number NCT07360691
Lead Sponsor Adichunchanagiri Institute of Medical Sciences, B G Nagara
Conditions Hernia, Ventral Hernia, Incisional Hernia, İnguinal Hernia, Abdominal Wall Hernia, Surgical Site Infection, Postoperative Complications
Enrollment 30 participants
Start Date 2026-01-05
Primary Completion 2026-03-08 (estimated)
Study Completion 2026-03-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-23