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临床试验/NCT04986111
NCT04986111Unknown不适用

The Efficacy of Purse-string Skin Closure With Negative Pressure Wound Therapy (NPWT) on Wound Recovery After Ileostomy Reversal: A Prospective Randomized Clinical Trial

Seoul National University Bundang Hospital2 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2021年1月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
138
试验地点
2
主要终点
Unsuccessful wound recovery rate

研究概览

简要总结

Evaluating the effectiveness of the existing 'linear suture + wound drain placement' and 'purse-string suture + negative pressure wound therapy' through a prospective comparative study

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • Patients experiencing ileostomy repair at multicenter

排除标准

  • Active bacterial infection needing antibiotics before surgery
  • parastomal infection before surgery
  • uncontrolled diabetes mellitus
  • Emergency repair of stoma (ex. stoma prolapse, high output stoma etc...)
  • Inflammatory bowel disease

结局指标

主要结局

Unsuccessful wound recovery rate

时间窗: Check at postoperative 30th day and report through study completion, an average of 1 year

(patients with unsuccessful wound recovery / all enrolled patients) x 100 \*\*Unsuccessful wound recovery definition: 1) Occurrence of Surgical Site Infection (SSI) or 2) reoperation due to wound complication or 3) delayed healing over 30 days or 4) Out patient department follow up more than 5 times

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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