NCT06980610

A Randomized Open Controlled Clinical Trial Comparing the Mean Healing Time With Collatamp Versus Directed Healing in Digestive Stoma Closures

A RANDOMIZEZ OPEN CONTROLLED CLINICAL TRIAL COMPARING THE MEN HEALING TIME WITH COLLATAMP VERSUS DIRECTED HEALING IN DIGESTIVE STOMA CLOSSURES

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The process of directed healing is a slow one, not without any constraints for patients. In contact with the intestinal flora during the stoma time, the tissues harboring digestive bacteria do not allow direct skin closure without the risk of complications during the restoration of digestive continuity after having to perform an ileal or colonic stoma. Collatamp interposition would allow direct wound closure without additional complications. Various studies have compared directed healing and direct skin closure during stoma closure/restoration of continuity. Overall, directed healing reduces the risk of infection, abscesses, and surgical time, but results in greater constraints for the patient, i.e., longer healing time, more pain, and a poorer cosmetic result compared to direct skin closure.

Conditions

• Surgery, Colorectal

Interventions

Type	Name	Description
PROCEDURE	digestive stoma closures	Both surgical techniques (Collatamp interposition and directed healing) are routinely used in the CVMC and Digestive Cancer Surgery departments for stoma closure or restoration of digestive continuity. The choice of technique is at the surgeon\'s discretion. Specific procedures related to the research: Procedures that differ from standard management are randomization and patient completion of a questionnaire.

Timeline

• Start date: 2025-05-15
• Primary completion: 2027-08-30
• Completion: 2027-08-30
• First posted: 2025-05-20
• Last updated: 2025-05-20