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

Not Applicable

Not yet recruiting

• Conditions: Surgery, Colorectal

• Registration Number: NCT06980610
• Lead Sponsor: Central Hospital, Nancy, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-15
• Study First Submitted: 2025-05-19
• Study First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Primary Completion: 2027-08-30
• Study Completion: 2027-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Person having received full information on the organization of the research and having signed their informed consent
• Patients aged 18 and over
• Patients requiring ileostomy or colostomy closure, or restoration of digestive continuity
• Person affiliated with a social security scheme or beneficiary of such a scheme

Exclusion Criteria

• Patient suffering from an immune deficiency (which would alter the healing process)
• Patient unable to complete the questionnaire
• Patient with a known intolerance, hypersensitivity, or allergy to aminoglycosides or bovine collagen
• Patient suffering from myasthenia gravis
• Woman of childbearing age without effective contraception
• Person referred to in Articles L. 1121-5, L. 1121-7, and L. 1121-8 of the French Public Health Code
• Pregnant woman, woman in labor, or breastfeeding mother
• Minor (non-emancipated)
• Adult subject to a legal protection measure (guardianship, curatorship, or legal protection)
• Adult unable to express consent . Person deprived of liberty by a judicial or administrative decision, person receiving psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time until complete healing expressed in days	6 months maximum	Duration of participation of the person participating in the research (including the follow-up period): 6 months maximum; Duration of statistical analysis and provision of the final report: 12 months