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

NCT06980610 | Not Yet Recruiting DMC

• 1 other identifier: 2024-A02240-47
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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

Keywords

SURGERY,; digestive stoma closures

Outcome Measures

Primary Outcomes (1)

• Time until complete healing expressed in days

  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

  6 months maximum

Study Arms (2)

COLLATAMP

EXPERIMENTAL

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

Procedure: digestive stoma closures

directed healing

ACTIVE COMPARATOR

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

Procedure: digestive stoma closures

Interventions

digestive stoma closures 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.

COLLATAMP; directed healing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Central Study Contacts

Matthias MHM Hoeffel-Morgenthaler

CONTACT

+33770058922; matt.mhm@sfr.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional research with minimal risks and constraints, not involving a product mentioned in Article L. 5311-1 of the CSP

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 20, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL