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

Central Hospital, Nancy, France

Status: Not yet enrolling

Conditions: Surgery, Colorectal

Treatments: Procedure: digestive stoma closures

Study type: Interventional

Funder types: Other

Identifiers

NCT06980610

2024-A02240-47

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

COLLATAMP

Experimental group

Description:

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

Treatment:

Procedure: digestive stoma closures

directed healing

Active Comparator group

Description:

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

Treatment:

Procedure: digestive stoma closures