A RANDOMIZEZ OPEN CONTROLLED CLINICAL TRIAL COMPARING THE MEN HEALING TIME WITH COLLATAMP VERSUS DIRECTED HEALING IN DIGESTIVE STOMA CLOSSURES
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 主要终点
- Time until complete healing expressed in days
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
COLLATAMP
The strategy under research is the surgical technique with Collatamp interposition between the musculoaponeurotic plane and the cutaneous plane during stoma closures.
干预措施: digestive stoma closures (Procedure)
directed healing
The strategy used as a reference is the surgical technique of directed healing, with the use of an Algosteril wick.
干预措施: digestive stoma closures (Procedure)
结局指标
主要结局
Time until complete healing expressed in days
时间窗: 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
次要结局
未报告次要终点