Early Clinical Outcomes of High-Purity Type I Collagen as a Biologic Reinforcement in Selected Hernia Repair Scenarios
Prospective Clinical Evaluation of High-Purity Type I Collagen as a Biologic Reinforcement in Selected High-Risk Hernia Repair Scenarios
Adichunchanagiri Institute of Medical Sciences, B G Nagara
25 participants
Jan 5, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria6
- 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
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Interventions
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)
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NCT07360691