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

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

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.

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 biocompatibility, resistance to infection, and tissue remodeling. High-Purity Type I Collagen (>97% purity) is an un-crosslinked, resorbable scaffold designed to support host tissue integration.

This prospective observational study systematically evaluates early clinical outcomes following HPTC-reinforced hernia repair, including surgical site infection, wound healing, postoperative pain, and early integrity of repair. The study is not designed to assess long-term recurrence.

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