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

NCT ID: NCT06980610

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2027-08-30

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.

Conditions

Surgery, Colorectal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

COLLATAMP

The strategy under research is the surgical technique with Collatamp interposition between the musculoaponeurotic plane and the cutaneous plane during stoma closures.

Group Type: EXPERIMENTAL

digestive stoma closures

Intervention Type: PROCEDURE

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.

directed healing

The strategy used as a reference is the surgical technique of directed healing, with the use of an Algosteril wick.

Group Type: ACTIVE_COMPARATOR

digestive stoma closures

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Matthias MHM Hoeffel-Morgenthaler

Role: CONTACT

matt.mhm@sfr.fr

+33770058922

Other Identifiers

2024-A02240-47

Identifier Type: -

Identifier Source: org_study_id