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NCT Number: NCT07360691

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

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.

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Key information

Conditions

Hernia Abdominal Wall Hernia Hernia, Abdominal Hernia, Inguinal Hernia, Ventral Incisional Hernia Infections Neurologic Manifestations Osteogenesis Imperfecta, Type IV Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgical Site Infection Surgical Wound Infection Ventral Hernia Wound Infection İnguinal Hernia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adichunchanagiri Institute of Medical Sciences

Mandya, Karnataka, 571448, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-Purity Type I Collagen Mesh

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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:

    • Intact repair: No evidence of fascial separation, wound disruption, or abnormal protrusion on inspection and palpation.
    • Fascial dehiscence: Partial or complete separation of the fascial closure identified clinically.
    • Clinical bulge: Localized protrusion at the repair site without confirmed fascial defect, detected on standing or straining examination.
    • 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.

  4. Length of Hospital Stay

    Time frame: From immediately after the surgery until hospital discharge

    Number of postoperative inpatient days

  5. 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

  6. 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)

Sponsors and collaborators

Lead sponsor

Adichunchanagiri Institute of Medical Sciences, B G Nagara

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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