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

Adichunchanagiri Institute of Medical Sciences, B G Nagara

Status: Enrolling

Conditions: Postoperative Complications; İnguinal Hernia; Incisional Hernia; Surgical Site Infection; Abdominal Wall Hernia; Hernia; Ventral Hernia

Treatments: Device: High-Purity Type I Collagen Mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT07360691

AIMS/IEC/007/2026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 1 patient group

HPTC-Reinforced Hernia Repair

Experimental group

Description:

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.

Treatment:

Device: High-Purity Type I Collagen Mesh