CompletedNot Applicable

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

India30 participantsStarted 2026-01-05

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With Early Postoperative Safety Events (Surgical Site Infection, Mesh-Related Adverse Events, or Reoperation)

Timeframe: Up to 8 weeks post-operatively

Trial details

NCT IDNCT07360691

SponsorAdichunchanagiri Institute of Medical Sciences, B G Nagara

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-08

Results submitted2026-03-14

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