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

Adichunchanagiri Institute of Medical Sciences, B G Nagara25 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

Early Postoperative Safety and Feasibility

Incidence of surgical site infection, mesh-related adverse events, and need for re-intervention or mesh removal within 8 weeks following surgery.

Time frame: Up to 8 weeks post-operatively

Secondary Outcomes

Early Wound Healing Outcomes

Time to epithelialization, wound complications (seroma, hematoma, dehiscence)

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

Absence of early fascial failure or wound breakdown on clinical examination

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