Surgery, ColorectalCLvsCDNCT06980610
A Randomized Open Controlled Clinical Trial Comparing the Mean Healing Time With Collatamp Versus Directed Healing in Digestive Stoma Closures
A study testing digestive stoma closures in people with Surgery, Colorectal, run by Central Hospital, Nancy, France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery, Colorectal
- What is being tested?
- digestive stoma closures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2025to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A RANDOMIZEZ OPEN CONTROLLED CLINICAL TRIAL COMPARING THE MEN HEALING TIME WITH COLLATAMP VERSUS DIRECTED HEALING IN DIGESTIVE STOMA CLOSSURES
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
- Being tested
- digestive stoma closures
- Keywords
- SURGERY,, digestive stoma closures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digestive stoma closuresProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| COLLATAMP | Experimental | The strategy under research is the surgical technique with Collatamp interposition between the musculoaponeurotic plane and the cutaneous plane during stoma closures. Receives: 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. Receives: Procedure: digestive stoma closures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start15 May 2025 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery, ColorectalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional research with minimal risks and constraints, not involving a product mentioned in Article L. 5311-1 of the CSP
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980610
- Sponsor's protocol ID
- 2024-A02240-47
- Acronym
- CLvsCD
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMIZEZ OPEN CONTROLLED CLINICAL TRIAL COMPARING THE MEN HEALING TIME WITH COLLATAMP VERSUS DIRECTED HEALING IN DIGESTIVE STOMA CLOSSURES
- ClinicalTrials.gov ID
- NCT06980610
- Acronym / sponsor ID
- CLvsCD / 2024-A02240-47
- Conditions
- Surgery, Colorectal
- Keywords
- SURGERY,, digestive stoma closures
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional research with minimal risks and constraints, not involving a product mentioned in Article L. 5311-1 of the CSP
| Arm | Type | Receives |
|---|---|---|
| COLLATAMP | Experimental | Procedure: digestive stoma closuresThe strategy under research is the surgical technique with Collatamp interposition between the musculoaponeurotic plane and the cutaneous plane during stoma closures. |
| directed healing | Active comparator | Procedure: digestive stoma closuresThe strategy used as a reference is the surgical technique of directed healing, with the use of an Algosteril wick. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digestive stoma closuresBoth 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. | Procedure or surgery | COLLATAMP, directed healing |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing digestive stoma closures in people with Surgery, Colorectal, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthias MHM Hoeffel-Morgenthaler (+33770058922, matt.mhm@sfr.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time until complete healing expressed in days (time frame: 6 months maximum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.