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

NCT07241091 | Completed Results

• 1 other identifier: AIMS/IEC/266/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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. The study tests whether Surgicoll-Mesh can reduce major postoperative intra-abdominal complications compared with standard management.

Conditions

Surgical Site Infection After Major Surgery; Ovarian Cancer (OvCa); Peritoneal Surface Malignancy; Postoperative Adhesion; Bowel Obstruction; Wound Complications

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

Outcome Measures

Primary Outcomes (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

  2 months post-surgery

Secondary Outcomes (7)

• Individual Complication Rates

  2 months

• Time to Bowel Function Recovery

  1 month

• Length of Intensive Care Unit Stay

  During index hospitalization

• Length of Hospital Stay

  During index hospitalization

• Device-related Adverse Events

  Within 2 months after surgery

Study Arms (2)

High Purity Type-I Collagen-based Peritoneal Substitute

ACTIVE COMPARATOR

Patients 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.

Device: High-Purity Type-I Collagen Scaffold

Standard Peritonectomy Closure

ACTIVE COMPARATOR

Patients 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.

Procedure: Standard Peritonectomy Closure

Interventions

High-Purity Type-I Collagen Scaffold DEVICE

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.

High Purity Type-I Collagen-based Peritoneal Substitute

Standard Peritonectomy Closure PROCEDURE

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

Standard Peritonectomy Closure

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
• Diagnosed peritoneal surface malignancy (colorectal, ovarian, appendiceal, mesothelioma, pseudomyxoma)
• Undergoing cytoreductive surgery ± HIPEC requiring peritonectomy
• ECOG 0-2, adequate organ function, informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Adichunchanagiri Institute of Medical Sciences, B G Nagara: lead
• JSS Medical College Hospital: collaborator

Study Sites (2)

Adichunchanagiri Institute of Medical Sciences

Mandya, Karnataka, 571448, India

Location

JSS Medical College Hospital

Mysore, Karnataka, 570004, India

Location

Related Publications (8)

• 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

  BACKGROUND

• 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.

  PMID: 39649230 BACKGROUND

• 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.

  PMID: 40747200 BACKGROUND

• 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.

  PMID: 40862036 BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 22153086 BACKGROUND

• 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.

  PMID: 30511047 BACKGROUND

MeSH Terms

Conditions

Peritoneal Neoplasms; Intestinal Obstruction; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Limitations and Caveats

First, although randomized and multicenter, the sample size was modest and powered primarily for short-term postoperative outcomes. Second, the open-label design may introduce performance bias; however, objective endpoints and blinded outcome assessment were employed to mitigate this risk. Third, while MRI provided valuable radiologic insight into adhesion formation, laparoscopy remains the gold standard for adhesion assessment and was not ethically justifiable in this context.

Results Point of Contact

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

naveen_uno1@yahoo.co.in

+91-9980023372

Study Officials

• NAVEEN NARAYAN, MS, MCh

  Adichunchanagiri Institute of Medical Sciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & HoD, Department of Plastic Reconstructive & Aesthetic Surgery

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: October 20, 2025
• Primary Completion: February 13, 2026
• Study Completion: February 21, 2026
• Last Updated: March 30, 2026
• Results First Posted: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 months post-publication
• Access Criteria: De-identified individual participant data will be made available to investigators upon reasonable request beginning 6 months after publication. Access will be granted to researchers who provide a methodologically sound proposal and agree to use the data only for research purposes. Researchers must sign a data access agreement. The Study Protocol and Statistical Analysis Plan (SAP) will also be shared 6 months post-publication.

Locations

IN (2)