AzTrials
AzTrials

Peritoneal Surface MalignancyNCT07241091

SurgiPerito Trial: High-Purity Type-I Collagen for Peritoneal Reconstruction After Cytoreductive Surgery

A study testing High-Purity Type-I Collagen Scaffold and Standard Peritonectomy Closure in people with Peritoneal Surface Malignancy and Postoperative Adhesion, run by Adichunchanagiri Institute of Medical Sciences, B G Nagara at 2 sites in India.

Completed

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

Official record
Search all trials

Trial summary

This dual-centre, randomized controlled trial evaluates the safety and efficacy of high-purity Type-I collagen-based biomaterial, as a peritoneal substitute following peritonectomy in patients undergoing cytoreductive surgery (CRS) for peritoneal surface malignancy. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
High-Purity Type-I Collagen Scaffold and Standard Peritonectomy Closure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesIndia
Study dates
20 Oct 2025to 21 Feb 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
  • Diagnosed peritoneal surface malignancy (colorectal, ovarian, appendiceal, mesothelioma, pseudomyxoma)
  • Undergoing cytoreductive surgery ± HIPEC requiring peritonectomy
  • ECOG 0-2, adequate organ function, informed consent

Who cannot join

  • Collagen allergy or active infection
  • Immunosuppression or chronic steroid use
  • Pregnancy/lactation
  • Uncontrolled sepsis, bowel perforation, or extensive small bowel resection

Trial locations and contacts

2 sites in 1 country.

India2 sites

  • Adichunchanagiri Institute of Medical Sciences

    Mandya, Karnataka, 571448

  • JSS Medical College Hospital

    Mysore, Karnataka, 570004

Other trials in India

About this study

Official title: A Randomized Controlled Trial of High-Purity Type-I Collagen-Based Biomaterial (Surgicoll-Mesh®) as a Peritoneal Substitute to Prevent Post-Peritonectomy Complications in Patients Undergoing Cytoreductive Surgery

This dual-centre, randomized controlled trial evaluates the safety and efficacy of high-purity Type-I collagen-based biomaterial, as a peritoneal substitute following peritonectomy in patients undergoing cytoreductive surgery (CRS) for peritoneal surface malignancy. The study tests whether Surgicoll-Mesh can reduce major postoperative intra-abdominal complications compared with standard management.

Read the detailed description

Peritonectomy during CRS often leads to adhesion formation, obstruction, and wound complications. High-purity Type-I collagen-based biomaterial, a resorbable collagen matrix, provides a temporary barrier and scaffold that promotes tissue regeneration and reduces adhesions. This trial will randomize 60 patients (30 per group) to receive standard closure or peritoneal reconstruction with high-purity Type-I collagen-based biomaterial. The primary endpoint is the incidence of major intra-abdominal complications within 2 months. Secondary endpoints include individual complication rates, bowel recovery, hospital stay, mesh-related events, and quality of life

Being tested
High-Purity Type-I Collagen Scaffold, Standard Peritonectomy Closure
Keywords
High-Purity Type-I Collagen, Collagen Biomaterial, Peritonectomy, Cytoreductive Surgery (CRS), Peritoneal Substitute, Adhesion Prevention, Peritoneal Reconstruction, Regenerative Collagen Matrix, HIPEC (Hyperthermic Intraperitoneal Chemotherapy), Intra-abdominal Healing
Medical subject headings
Peritoneal Neoplasms, Intestinal Obstruction, Ovarian Neoplasms

What participants receive

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

  • High-Purity Type-I Collagen ScaffoldDevice

    Peritoneal reconstruction using High-Purity Type-I Collagen Scaffold after peritonectomy. Purpose is to act as a biologic peritoneal substitute promoting tissue regeneration and reducing postoperative adhesions and complications.

  • Standard Peritonectomy ClosureProcedure or surgery

    Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.

Study groups in NCT07241091
Study groupRoleWhat they receive
High Purity Type-I Collagen-based Peritoneal SubstituteActive comparatorPatients undergoing cytoreductive surgery (CRS) with peritonectomy will receive intraoperative peritoneal reconstruction using High Purity Type-I Collagen-based Peritoneal Substitute, a sterile, resorbable, high-purity Type-I collagen biomaterial. The mesh is tailored to the peritonectomy defect and secured with absorbable sutures prior to abdominal closure.
Receives: Device: High-Purity Type-I Collagen Scaffold
Standard Peritonectomy ClosureActive comparatorPatients undergoing cytoreductive surgery with peritonectomy will have standard closure of the peritoneal defect without the use of any biomaterial or mesh substitute. Surgical closure will follow institutional standard of care.
Receives: Procedure: Standard Peritonectomy Closure

What is being measured

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

  1. Incidence of Major Intra-abdominal Complications

    Incidence of major intra-abdominal complications (adhesive SBO, enterocutaneous fistula, reoperation, grade ≥3 wound complication) within 2 months post-surgery

    Measured: 2 months post-surgery

Secondary outcomes (7)

  1. Individual Complication Rates

    Individual complication rates (intraperitoneal adhesions, bowel obstruction, wound infection, hernia, fistula)

    Measured: 2 months

  2. Time to Bowel Function Recovery

    Time to bowel function recovery and diet tolerance

    Measured: 1 month

  3. Length of Intensive Care Unit Stay

    Duration of postoperative intensive care unit stay following cytoreductive surgery.

    Measured: During index hospitalization

  4. Length of Hospital Stay

    Total duration of hospitalization following cytoreductive surgery.

    Measured: During index hospitalization

  5. Device-related Adverse Events

    Any adverse event deemed related to the implanted High-Purity Type-I Collagen biomaterial, including mesh reaction, infection, seroma, rejection, or need for mesh removal, assessed within the 2-month postoperative period.

    Measured: Within 2 months after surgery

  6. MRI-Detected Intra-Abdominal Adhesions

    Number of participants with dense intra-abdominal adhesions detected by postoperative magnetic resonance imaging.

    Measured: Within 2 months after surgery

  7. Change in Quality of Life Domains (EORTC QLQ-C30)

    Change from baseline in quality of life assessed using the EORTC QLQ-C30 questionnaire. Scores are transformed to a 0-100 scale.

    For global health and functional scales, higher scores indicate better outcomes and higher change values represent improvement.

    For pain (symptom scales), higher scores indicate worse symptoms; therefore, reductions from baseline represent improvement

    Measured: Baseline to 2 months after surgery

Timeline

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

  1. First posted21 Nov 2025
  2. Study start20 Oct 2025
  3. Primary completion13 Feb 2026
  4. Study completion21 Feb 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07241091
Sponsor's protocol ID
AIMS/IEC/266/2025
Status last verified
Mar 2026
First submitted
17 Nov 2025
Last updated
30 Mar 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data and statistical code will be available upon reasonable request after publication of results.

Publications

  • Naveen Narayan, KN rajeSh, ChethaN ShivaNNaiah, SuhaS N Gowda. Collagen-based Mesh in the Treatment of Posthernioplasty Mesh Infection in Ventral Hernias: A Case Series. Journal of Clinical and Diagnostic Research. 2024 Sep, Vol-18(9): PR01-PR03

  • Narayan N, Gowda S, Shivannaiah C. A Randomized Controlled Clinical Trial Comparing the Use of High Purity Type-I Collagen-Based Skin Substitute vs. Dehydrated Human Amnion/Chorion Membrane in the Treatment of Diabetic Foot Ulcers. Cureus. 2024 Dec 5;16(12):e75182. doi: 10.7759/cureus.75182. eCollection 2024 Dec.

    PubMed 39649230

  • Narayan N, Shivannaiah C, Gowda S. Evaluating the Efficacy of High-Purity Type I Collagen-Based Skin Substitute Versus Dehydrated Human Amnion/Chorion Membrane in the Treatment of Venous Leg Ulcers: A Randomized Controlled Clinical Trial. Cureus. 2025 Jul 30;17(7):e89031. doi: 10.7759/cureus.89031. eCollection 2025 Jul.

    PubMed 40747200

  • Narayan N, Ramegowda YH, Raghupathi DS, Chethan S, Gowda S. Biological Skin Substitutes in Pressure Ulcers: High-Purity Type I Collagen-Based Versus Amnion/Chorion Membrane. Cureus. 2025 Aug 25;17(8):e90956. doi: 10.7759/cureus.90956. eCollection 2025 Aug.

    PubMed 40862036

  • Dhanraj P, Naveen N, Babu KR, Mahesh M, Hanumanthaiah KS: Healicoll - an alternate to flap cover for bare bones and tendons. Acta Medica International. 2016, 3:146-50.

  • Naveen N, Dharini K, Yashas HR: Multifaceted role of the acellular dermal matrix in novel wound healing: a case series. J Clin Diag Res. 2025, 19:01-05. 10.7860/JCDR/2025/79891.21070

  • Subramanian A, Liang MK. A 60-year literature review of stump appendicitis: the need for a critical view. Am J Surg. 2012 Apr;203(4):503-7. doi: 10.1016/j.amjsurg.2011.04.009. Epub 2011 Dec 6.

    PubMed 22153086

  • Tzivanakis A, Dayal SP, Arnold SJ, Mohamed F, Cecil TD, Venkatasubramaniam AK, Moran BJ. Biological mesh is a safe and effective method of abdominal wall reconstruction in cytoreductive surgery for peritoneal malignancy. BJS Open. 2018 Aug 2;2(6):464-469. doi: 10.1002/bjs5.93. eCollection 2018 Dec.

    PubMed 30511047

Questions about this trial

What is this clinical trial studying?

A study testing High-Purity Type-I Collagen Scaffold and Standard Peritonectomy Closure in people with Peritoneal Surface Malignancy and Postoperative Adhesion, run by Adichunchanagiri Institute of Medical Sciences, B G Nagara at 2 sites 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 4 inclusion and 4 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 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 30 Mar 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?

Incidence of Major Intra-abdominal Complications (time frame: 2 months post-surgery). 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 NCT07241091, which also lists 8 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 30 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in