Multiple segmented Purse-string suturing vs Interrupted simple suturing of subcutaneous layer in mastectomy wounds: A Randomized Controlled Trial
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
Rahul Gowda R
Kasturba Medical College, Manipal
