Clinical Trial

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

Study acronym: CLvsCD
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT06980610
Lead Sponsor Central Hospital, Nancy, France
Conditions Surgery, Colorectal
Enrollment 64 participants
Start Date 2025-05-15
Primary Completion 2027-08-30 (estimated)
Study Completion 2027-08-30 (estimated)
Updated on ClinicalTrials.gov 2025-05-20