NCT07241091

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

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

Interventions

Type	Name	Description
DEVICE	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.
PROCEDURE	Standard Peritonectomy Closure	Conventional Closure, to serve as the comparator arm for evaluating complication rates, adhesion formation, and recovery outcomes.

Timeline

• Start date: 2025-10-20
• Primary completion: 2026-02-13
• Completion: 2026-02-21
• First posted: 2025-11-21
• Last updated: 2026-03-30
• Results posted: 2026-03-30

Locations

2 sites across 1 country: India