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

April 2, 2026 updated by: Adichunchanagiri Institute of Medical Sciences, B G Nagara

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Mandya, Karnataka, India, 571448
        • Adichunchanagiri Institute of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HPTC-Reinforced Hernia Repair
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.
Device: High-Purity Type I Collagen Mesh
High-Purity Type I Collagen mesh (>97% purity), un-crosslinked and resorbable, designed to function as a temporary biologic scaffold facilitating host tissue integration and remodeling. The device is applied as a biologic reinforcement following anatomical hernia repair in selected high-risk or contaminated surgical fields where permanent synthetic mesh placement is associated with increased risk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Early Postoperative Safety Events (Surgical Site Infection, Mesh-Related Adverse Events, or Reoperation)
Time Frame: Up to 8 weeks post-operatively
Incidence (number of participants) of surgical site infection, mesh-related adverse events, and need for re-intervention or mesh removal within 8 weeks postoperatively.
Up to 8 weeks post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay
Time Frame: From immediately after the surgery until hospital discharge
Number of postoperative inpatient days
From immediately after the surgery until hospital discharge
Patient Satisfaction With Hernia Repair
Time Frame: 8 weeks post-operatively

Patient-reported satisfaction with surgical outcome assessed on a 5-point Likert scale:

Very satisfied / Satisfied / Neutral / Dissatisfied / Very dissatisfied
8 weeks post-operatively
Hernia-Specific Quality of Life
Time Frame: Baseline and 8 weeks post-operatively
Hernia-specific quality of life assessed using European Registry for Abdominal Wall Hernias Quality of Life Score (EuraHS-QoL), covering: Pain at rest and during activity, Restriction of activities, Cosmetic discomfort. Scores range from 0 (no impairment) to 90 (worst impairment)
Baseline and 8 weeks post-operatively
Number of Participants With Early Wound Complications (Seroma, Hematoma, or Wound Dehiscence)
Time Frame: Up to 8 weeks
Incidence (number of participants) of wound complications including seroma, hematoma, and wound dehiscence within 8 weeks postoperatively.
Up to 8 weeks
Postoperative Change in Visual Analog Scale (VAS) Pain Scores
Time Frame: Baseline (preoperatively) to 8 weeks postoperatively
Change in pain intensity assessed using the Visual Analog Scale for Pain, a patient-reported numeric scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores represent worse pain intensity.
Baseline (preoperatively) to 8 weeks postoperatively
Early Clinical Integrity of Repair
Time Frame: Up to 8 weeks

Clinical integrity of repair assessed by standardized postoperative clinical examination at scheduled follow-up visits (2, 4, and 8 weeks).

Definitions:

  1. Intact repair: No evidence of fascial separation, wound disruption, or abnormal protrusion on inspection and palpation.
  2. Fascial dehiscence: Partial or complete separation of the fascial closure identified clinically.
  3. Clinical bulge: Localized protrusion at the repair site without confirmed fascial defect, detected on standing or straining examination.
  4. Early recurrence: Reappearance of a hernia defect at or adjacent to the repair site confirmed on clinical examination within 8 weeks.

All assessments were performed by the treating surgical team using standardized clinical evaluation.
Up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adichunchanagiri Institute of Medical Sciences, B G Nagara

Investigators

  • Study Chair: Prema Dhanraj, MS, MCh, Rajarajeshwari Medical College and Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2026

Primary Completion (Actual)

March 8, 2026

Study Completion (Actual)

March 12, 2026

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

January 17, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIMS/IEC/298/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the results reported in this clinical study will be made available upon reasonable request. Shared data will include baseline characteristics, peri-operative variables, postoperative outcomes, and patient-reported outcome measures collected during the 8-week follow-up period. All shared data will be fully anonymized, with no direct or indirect identifiers.

IPD Sharing Time Frame

Data will be available beginning 6 months after publication of the primary study results and will remain available for up to 5 years thereafter.

IPD Sharing Access Criteria

Access to de-identified IPD will be granted to qualified researchers upon submission of:

A methodologically sound research proposal

Intended use aligned with scientific and ethical standards

Requests will be reviewed by the study investigators. Data will be shared under a data use agreement to ensure appropriate use and protection of participant confidentiality.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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