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

Launched by CENTRAL HOSPITAL, NANCY, FRANCE · May 19, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to close an opening in the abdomen after surgery for conditions like a colostomy or ileostomy. One method, called "directed healing," is slower and can lead to more pain and longer healing times for patients. The other method uses a product called Collatamp, which may allow for quicker and easier closure without the same level of complications. The goal of the trial is to see if using Collatamp can help patients heal faster and with less discomfort compared to the traditional method.

To participate in this trial, individuals must be 18 years or older and need to have had surgery that requires closure of an ileostomy or colostomy. They also need to be able to provide informed consent and be part of a social security scheme. However, people with certain health issues, like immune deficiencies or allergies to specific materials, cannot join. If eligible, participants can expect to be part of a study that aims to improve the healing process and overall experience after surgery. It's important to note that this trial is not yet recruiting participants.

Gender

ALL

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