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

NCT07360691 | Completed Results

• 1 other identifier: AIMS/IEC/298/2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hernia; Ventral Hernia; Incisional Hernia; İnguinal Hernia; Abdominal Wall Hernia; Surgical Site Infection; Postoperative Complications

Keywords

Hernia Repair; Ventral Hernia Repair; Incisional Hernia Repair; Inguinal Hernia Repair; Biological Mesh; Type I Collagen; Wound Healing; Postoperative Pain; Hernia Recurrence

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 8 weeks post-operatively

Secondary Outcomes (6)

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

  Up to 8 weeks

• Postoperative Change in Visual Analog Scale (VAS) Pain Scores

  Baseline (preoperatively) to 8 weeks postoperatively

• Early Clinical Integrity of Repair

  Up to 8 weeks

• Length of Hospital Stay

  From immediately after the surgery until hospital discharge

• Patient Satisfaction With Hernia Repair

  8 weeks post-operatively

Study Arms (1)

HPTC-Reinforced Hernia Repair

EXPERIMENTAL

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

Interventions

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.

HPTC-Reinforced Hernia Repair

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adichunchanagiri Institute of Medical Sciences, B G Nagara: lead

Study Sites (1)

Adichunchanagiri Institute of Medical Sciences

Mandya, Karnataka, 571448, India

Location

Related Publications (7)

• Arturi K, Harris EJ, Gasser L, Escher BI, Braun G, Bosshard R, Hollender J. MLinvitroTox reloaded for high-throughput hazard-based prioritization of high-resolution mass spectrometry data. J Cheminform. 2025 Jan 31;17(1):14. doi: 10.1186/s13321-025-00950-4.

  PMID: 39891244 BACKGROUND

• Ong JEX. How to restore lower complete edentulism with implant-supported overdentures: an evidence-based clinical management. Br Dent J. 2024 Nov;237(10):773-777. doi: 10.1038/s41415-024-7842-5. Epub 2024 Nov 22.

  PMID: 39572811 BACKGROUND

• Cevasco M, Itani KM. Ventral hernia repair with synthetic, composite, and biologic mesh: characteristics, indications, and infection profile. Surg Infect (Larchmt). 2012 Aug;13(4):209-15. doi: 10.1089/sur.2012.123. Epub 2012 Aug 22.

  PMID: 22913337 BACKGROUND

• Huntington CR, Cox TC, Blair LJ, Schell S, Randolph D, Prasad T, Lincourt A, Heniford BT, Augenstein VA. Biologic mesh in ventral hernia repair: Outcomes, recurrence, and charge analysis. Surgery. 2016 Dec;160(6):1517-1527. doi: 10.1016/j.surg.2016.07.008. Epub 2016 Aug 12.

  PMID: 27528210 BACKGROUND

• Cheng AW, Abbas MA, Tejirian T. Outcome of abdominal wall hernia repair with biologic mesh: Permacol versus Strattice. Am Surg. 2014 Oct;80(10):999-1002.

  PMID: 25264647 BACKGROUND

• Nahabedian MY, Sosin M, Bhanot P. A Current Review of Biologic Meshes in Abdominal Wall Reconstruction. Plast Reconstr Surg. 2018 Sep;142(3 Suppl):74S-81S. doi: 10.1097/PRS.0000000000004866.

  PMID: 30138272 BACKGROUND

• Rhon-Calderon EA, Galarza RA, Lomniczi A, Faletti AG. The systemic and gonadal toxicity of 3-methylcholanthrene is prevented by daily administration of alpha-naphthoflavone. Toxicology. 2016 Apr 15;353-354:58-69. doi: 10.1016/j.tox.2016.05.005. Epub 2016 May 6.

  PMID: 27163632 BACKGROUND

MeSH Terms

Conditions

Hernia; Hernia, Ventral; Incisional Hernia; Hernia, Inguinal; Hernia, Abdominal; Surgical Wound Infection; Postoperative Complications; Osteogenesis Imperfecta, Type IV; Pain, Postoperative

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Wound Infection; Infections; Pain; Neurologic Manifestations; Signs and Symptoms

Limitations and Caveats

Single-arm design precludes direct comparison with standard mesh repair or suture-only repair. Follow-up duration was limited to eight weeks and does not permit assessment of long-term durability or recurrence. Study was conducted at a single centre, which may limit generalizability.

Results Point of Contact

• Title: Prof Naveen Narayan
• Organization: Adichunchanagiri Institute of Medical Sciences

naveen_uno1@yahoo.co.in

+91-9980023372

Study Officials

• Prema Dhanraj, MS, MCh

  Rajarajeshwari Medical College and Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 22, 2026
• Study Start: January 5, 2026
• Primary Completion: March 8, 2026
• Study Completion: March 12, 2026
• Last Updated: April 23, 2026
• Results First Posted: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

IN (1)