N/A
Completed N=30
Prospective Clinical Evaluation of High-Purity Type I Collagen in Select High-Risk Hernia Repair Scenarios
hernia · Ventral Hernia · Incisional Hernia · Inguinal Hernia
Source: ClinicalTrials.gov NCT07360691 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: Number of Participants With Early Postoperative Safety Events (Surgical Site Infection, Mesh-Related Adverse Events, or Reoperation) — 4; 0; 0; 0 Participants
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.
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 | — |
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
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. Informational only — not medical advice.