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NCT Number: NCT06980610

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

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.

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Key information

Conditions

Surgery, Colorectal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Time until complete healing expressed in days

    Time frame: 6 months maximum

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Matthias MHM Hoeffel-Morgenthaler

CONTACT

[email protected]

+33770058922

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

A RANDOMIZEZ OPEN CONTROLLED CLINICAL TRIAL COMPARING THE MEN HEALING TIME WITH COLLATAMP VERSUS DIRECTED HEALING IN DIGESTIVE STOMA CLOSSURES

Acronym: CLvsCD

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 20, 2025
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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