SurgiPerito Trial: High-Purity Type-I Collagen for Peritoneal Reconstruction After Cytoreductive Surgery
NCT ID: NCT07241091
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-10-20
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High Purity Type-I Collagen-based Peritoneal Substitute
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.
High-Purity Type-I Collagen Scaffold
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 Closure
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.
Standard Peritonectomy Closure
Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.
Interventions
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High-Purity Type-I Collagen Scaffold
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 Closure
Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed peritoneal surface malignancy (colorectal, ovarian, appendiceal, mesothelioma, pseudomyxoma)
* Undergoing cytoreductive surgery ± HIPEC requiring peritonectomy
* ECOG 0-2, adequate organ function, informed consent
Exclusion Criteria
* Immunosuppression or chronic steroid use
* Pregnancy/lactation
* Uncontrolled sepsis, bowel perforation, or extensive small bowel resection
18 Years
75 Years
ALL
No
Sponsors
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JSS Medical College Hospital
UNKNOWN
Adichunchanagiri Institute of Medical Sciences, B G Nagara
OTHER
Responsible Party
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Dr Naveen Narayan MS, MCh (Plastic Surgery)
Professor & HoD, Department of Plastic Reconstructive & Aesthetic Surgery
Principal Investigators
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NAVEEN NARAYAN, MS, MCh
Role: STUDY_CHAIR
Adichunchanagiri Institute of Medical Sciences
Locations
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Adichunchanagiri Institute of Medical Sciences
Mandya, Karnataka, India
JSS Medical College Hospital
Mysore, Karnataka, India
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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AIMS/IEC/266/2025
Identifier Type: -
Identifier Source: org_study_id
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