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RECRUITING
NCT07360691
NA

Early Clinical Outcomes of High-Purity Type I Collagen as a Biologic Reinforcement in Selected Hernia Repair Scenarios

Sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara

View on ClinicalTrials.gov

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.

Official title: Prospective Clinical Evaluation of High-Purity Type I Collagen as a Biologic Reinforcement in Selected High-Risk Hernia Repair Scenarios

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2026-01-05

Completion Date

2026-03

Last Updated

2026-01-22

Healthy Volunteers

No

Interventions

DEVICE

High-Purity Type I Collagen Mesh

High-Purity Type I Collagen mesh (\>97% purity), un-crosslinked and resorbable, designed to function as a temporary biologic scaffold facilitating host tissue integration and remodeling. The device is applied as a biologic reinforcement following anatomical hernia repair in selected high-risk or contaminated surgical fields where permanent synthetic mesh placement is associated with increased risk.

Locations (1)

Adichunchanagiri Institute of Medical Sciences

Mandya, Karnataka, India