The Efficacy of Purse-string Skin Closure With Negative Pressure Wound Therapy (NPWT) on Wound Recovery After Ileostomy Reversal: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 138
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Linear skin closure with wound drain
Reduce fluid collection and dead space by inserting drain into the subcutaneous layer using the wound closure method previously used in the experimental center. The linear suture has a relatively quick time to stitch out.
干预措施: Linear skin closure with wound drain (Procedure)
Purse-string skin closure with negative pressure wound therapy
Close the wound with a purse-string suture which is better in terms of surgical site infection but known to take a long time for wound healing, and use negative pressure wound therapy to help granulation of tissues and help healing.
干预措施: Purse-string skin closure with negative pressure wound therapy (Procedure)
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