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

Adichunchanagiri Institute of Medical Sciences, B G Nagara30 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hernia Ventral Hernia Incisional Hernia

Interventions

High-Purity Type I Collagen MeshDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Incidence (number of participants) of surgical site infection, mesh-related adverse events, and need for re-intervention or mesh removal within 8 weeks postoperatively.

Time frame: Up to 8 weeks post-operatively

Secondary Outcomes

Number of Participants With Early Wound Complications (Seroma, Hematoma, or Wound Dehiscence)

Incidence (number of participants) of wound complications including seroma, hematoma, and wound dehiscence within 8 weeks postoperatively.

Time frame: Up to 8 weeks

Postoperative Change in Visual Analog Scale (VAS) Pain Scores

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.

Time frame: Baseline (preoperatively) to 8 weeks postoperatively

Early Clinical Integrity of Repair

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.

Time frame: Up to 8 weeks

Length of Hospital Stay

Number of postoperative inpatient days

Time frame: From immediately after the surgery until hospital discharge

Patient Satisfaction With Hernia Repair

Patient-reported satisfaction with surgical outcome assessed on a 5-point Likert scale: Very satisfied / Satisfied / Neutral / Dissatisfied / Very dissatisfied

Time frame: 8 weeks post-operatively

Hernia-Specific Quality of Life

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)

Time frame: Baseline and 8 weeks post-operatively