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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COLLATAMP | Experimental | The strategy under research is the surgical technique with Collatamp interposition between the musculoaponeurotic plane and the cutaneous plane during stoma closures. |
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| directed healing | Active Comparator | The strategy used as a reference is the surgical technique of directed healing, with the use of an Algosteril wick. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthias MHM Hoeffel-Morgenthaler | Contact | +33770058922 | matt.mhm@sfr.fr |
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Interventional research with minimal risks and constraints, not involving a product mentioned in Article L. 5311-1 of the CSP
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