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临床试验/CTRI/2025/07/089967
CTRI/2025/07/089967招募中4 期

Multiple segmented Purse-string suturing vs Interrupted simple suturing of subcutaneous layer in mastectomy wounds: A Randomized Controlled Trial

Dean DrAnil Bhat K1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年7月14日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
To compare wound dimensions between the two suturing techniques

研究概览

简要总结

After obtaining approval from the IEC, informed consent will be obtained from the participants posted for mastectomy. Patient will be randomly choosing one of the six surgical units and undergo the standard of care suturing technique of that particular unit. Three surgical units form Cluster ISS - interrupted simple subcutaneous suturing and another 3 surgical units form Cluster PSS  - Segmented purse string suturing. After mastectomy is completed and just before the closure, the dimensions of the wound are assessed and is closed using segmented purse string technique or  interrupted simple subcutaneous suturing based on the cluster group. The wound dimensions after closure is then measured. Patients of both clusters are reassessed for wound infection on the day of first post operative wound examination and any subsequent follow-up days up to 30+10 days or commencement of adjuvant therapy, to look for any infection, flap necrosis or delay in wound healing. The results of the two groups will be compared to establish non inferiority.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
Female

入选标准

  • Female patients undergoing Mastectomy.

排除标准

  • Patients with preexisting skin infections at surgical site Immunocompromised patients (HIV, Uncontrolled diabetes mellitus, Long term steroid use) Prior chest radiation Collagen vascular disorders.

结局指标

主要结局

To compare wound dimensions between the two suturing techniques

时间窗: 40 days

次要结局

  • The extent of flap necrosis(40 days)
  • Delayed Wound healing(40 days)
  • Incidence of Wound infection(40 days)
  • Day of suture removal(30 days)

研究者

发起方
Dean DrAnil Bhat K
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Rahul Gowda R

Kasturba Medical College, Manipal

研究点 (1)

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