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HerniaNCT07360691

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

A study testing High-Purity Type I Collagen Mesh in people with Hernia and Ventral Hernia, run by Adichunchanagiri Institute of Medical Sciences, B G Nagara at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hernia, Ventral Hernia, Incisional Hernia
What is being tested?
High-Purity Type I Collagen Mesh
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteIndia
Study dates
5 Jan 2026to 12 Mar 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

India1 site

  • Adichunchanagiri Institute of Medical Sciences

    Mandya, Karnataka, 571448

Other trials in India

About this study

Official title: 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.

Read the 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.

Being tested
High-Purity Type I Collagen Mesh
Keywords
Hernia Repair, Ventral Hernia Repair, Incisional Hernia Repair, Inguinal Hernia Repair, Biological Mesh, Type I Collagen, Wound Healing, Postoperative Pain, Hernia Recurrence
Medical subject headings
Hernia, Hernia, Ventral, Incisional Hernia, Hernia, Inguinal, Hernia, Abdominal, Surgical Wound Infection, Postoperative Complications, Osteogenesis Imperfecta, Type IV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07360691
Study groupRoleWhat they receive
HPTC-Reinforced Hernia RepairExperimentalParticipants 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.
Receives: Device: High-Purity Type I Collagen Mesh

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 8 weeks post-operatively

Secondary outcomes (6)

  1. 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.

    Measured: Up to 8 weeks

  2. 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.

    Measured: Baseline (preoperatively) to 8 weeks postoperatively

  3. 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.

    Measured: Up to 8 weeks

  4. Length of Hospital Stay

    Number of postoperative inpatient days

    Measured: From immediately after the surgery until hospital discharge

  5. 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

    Measured: 8 weeks post-operatively

  6. 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)

    Measured: Baseline and 8 weeks post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2026
  2. Study start5 Jan 2026
  3. Primary completion8 Mar 2026
  4. Study completion12 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07360691
Sponsor's protocol ID
AIMS/IEC/298/2026
Status last verified
Apr 2026
First submitted
12 Jan 2026
Last updated
23 Apr 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 39891244

  • 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.

    PubMed 39572811

  • 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.

    PubMed 22913337

  • 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.

    PubMed 27528210

  • 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.

    PubMed 25264647

  • 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.

    PubMed 30138272

  • 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.

    PubMed 27163632

Questions about this trial

What is this clinical trial studying?

A study testing High-Purity Type I Collagen Mesh in people with Hernia and Ventral Hernia, run by Adichunchanagiri Institute of Medical Sciences, B G Nagara at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07360691, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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