Status:
NOT_YET_RECRUITING
A Randomized Open Controlled Clinical Trial Comparing the Mean Healing Time With Collatamp Versus Directed Healing in Digestive Stoma Closures
Lead Sponsor:
Central Hospital, Nancy, France
Conditions:
Surgery, Colorectal
Eligibility:
All Genders
18+ years
Phase:
NA
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 all...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2027
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06980610
Start Date
May 15 2025
End Date
August 30 2027
Last Update
May 20 2025
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