Overview
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.
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 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.
Eligibility
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
