Status:
RECRUITING
Early Clinical Outcomes of High-Purity Type I Collagen as a Biologic Reinforcement in Selected Hernia Repair Scenarios
Lead Sponsor:
Adichunchanagiri Institute of Medical Sciences, B G Nagara
Conditions:
Hernia
Ventral Hernia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 ...
Detailed Description
Synthetic mesh has reduced hernia recurrence but is associated with significant complications in contaminated fields and high-risk patients. Biologic meshes offer potential advantages including biocom...
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Clean, low-risk primary hernia suitable for synthetic mesh
- Large defects requiring permanent load-bearing prosthesis
- Generalized peritonitis or uncontrolled sepsis
- Known collagen hypersensitivity
- Pregnancy
- Inability to comply with follow-up
Key Trial Info
Start Date :
January 5 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT07360691
Start Date
January 5 2026
End Date
March 1 2026
Last Update
January 22 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Adichunchanagiri Institute of Medical Sciences
Mandya, Karnataka, India, 571448