N/A N=30 Treatment

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

Hernia · Ventral Hernia · Incisional Hernia · İnguinal Hernia · Abdominal Wall Hernia

Bottom Line

View on ClinicalTrials.gov: NCT07360691 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2026

Primary outcome: Primary: Number of Participants With Early Postoperative Safety Events (Surgical Site Infection, Mesh-Related Adverse Events, or Reoperation) — 4; 0; 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: High-Purity Type I Collagen Mesh (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara
Primary completion: Mar 2026

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Early Postoperative Safety Events (Surgical Site Infection, Mesh-Related Adverse Events, or Reoperation)	4; 0; 0; 0; 0	—
SECONDARY Number of Participants With Early Wound Complications (Seroma, Hematoma, or Wound Dehiscence)	2; 0; 0	—
SECONDARY Postoperative Change in Visual Analog Scale (VAS) Pain Scores	6.0; 4.1; 3.4; 2.9	—
SECONDARY Early Clinical Integrity of Repair	30; 0; 0; 0	—
SECONDARY Length of Hospital Stay	3.2	—
SECONDARY Patient Satisfaction With Hernia Repair	16; 11; 3; 0; 0	—
SECONDARY Hernia-Specific Quality of Life	42; 21	—

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT07360691). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.