Prospective Clinical Evaluation of High-Purity Type I Collagen as a Biologic Reinforcement in Selected High-Risk Hernia Repair Scenarios
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Age ≥18 years
• Ventral, incisional, umbilical, or para-umbilical hernia
• Contaminated or potentially contaminated surgical field
• Hernia repair following infected mesh explantation
• High-risk patients (diabetes, obesity, smoking, immunosuppression)
• Ability to provide informed consent
Locations
Other Locations
India
Adichunchanagiri Institute of Medical Sciences
RECRUITING
Mandya
Contact Information
Primary
Naveen Narayan, MS, MCh
naveen_uno1@yahoo.co.in
9980023372
Time Frame
Start Date: 2026-01-05
Estimated Completion Date: 2026-03
Participants
Target number of participants: 25
Treatments
Experimental: HPTC-Reinforced Hernia Repair
Participants undergo standard hernia repair with primary fascial closure where feasible, reinforced using High-Purity Type I Collagen mesh (Surgicoll-Mesh®). The biologic mesh is used as an adjunct reinforcement and not as a routine replacement for permanent synthetic mesh. Mesh placement (onlay or sublay) and peri-operative management are performed according to surgeon discretion and institutional protocols. The arm evaluates early postoperative safety, wound healing, and short-term clinical outcomes over an 8-week follow-up period in selected high-risk or contaminated hernia repair scenarios.
Related Therapeutic Areas
Sponsors
Leads: Adichunchanagiri Institute of Medical Sciences, B G Nagara