Comparative Analysis of Quilting Sutures With a Single Axillary Drain Versus Double Drains in the Axillary and Pectoral Regions for the Prevention of Seroma After Modified Radical Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Seroma Formation
研究概览
简要总结
Normally, after this surgery, skin is stitched in the usual simple way, with no quilting, and two drains are put in to remove serosa, one under the arm and one on the chest. In this study, the investigator will use a different type of stitch called a quilting stitch, which helps stick the skin to the chest muscle so there is less serosa collection. The investigator will compare two groups:
- Group A: Quilting stitches with two drains (one under the arm and one on the chest).
- Group B: Quilting stitches with one drain only (under the arm).
详细描述
All surgeries in this study will be performed by a consultant surgeon with at least 2 years of experience in breast surgery. This ensures uniformity and minimizes variation in outcomes related to surgical expertise Patients undergoing MRM will be divided into two groups, A & B. Flap quilting (skin flaps are sutured to the pectoralis muscle in interrupted fashion) will be done in both the groups using a Vicryl 2/0 suture, & skin will be closed using skin staplers.
Participants will be randomly assigned to one of the two study groups (Group A or Group B) using computer-based randomisation software. This ensures that the allocation is unbiased and purely by chance.
In group A double drains will be placed, one in pectoral region and the other in axillary region, while in group B single drain will be placed in axillary region; a 20 Fr JP drain would be used in both the groups Participants will be informed about the study's purpose, confidentiality will be ensured, and written informed consent will be obtained in the language of their preference (English/Urdu).
Observation will be made on the seroma formation, drain outputs, duration of drain placement & pain using the Visual Analogue Score (VAS) & incidence of surgical site infection.
The patient would be followed for drain output from postoperative day 1 to 30 (depending upon the removal of the drain), POD 7 & POD 14 and the subsequent next follow-up, & the patients will be assessed for seroma formation & surgical site infection & pain score. Seroma formation will be detected on clinical evaluation & will be confirmed on ultrasound imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients older than 18 years but less than 70 years of age,
- •Diagnosed with breast carcinoma.
- •All the patients undergoing upfront MRM,
- •All patients undergoing MRM post-neoadjuvant chemotherapy.
排除标准
- •Mastectomy & sentinel lymph node biopsy
- •Breast reconstruction surgery
- •Defect covering flaps
研究组 & 干预措施
Group A (Double Drain)
In group A double drains will be placed, one in pectoral region and the other in axillary region.
干预措施: Double drains will be placed (Procedure)
Group B (Single Drain)
while in group B, a single drain will be placed in axillary region; a 20 Fr JP drain would be used in both the groups
干预措施: A single drain will be placed (Procedure)
结局指标
主要结局
Seroma Formation
时间窗: Post-operative day 1 to day 30
Collection of fluid at the surgical bed, under the skin, confirmed by ultrasonography
次要结局
- Infection(Post-operative day 1 to day 30)
- Duration of drains(Post-operative day 1 to day 30)
- Post-operative pain(Post-operative day 1 to day 30)
研究者
Bushra shirazi
Professor
Sindh Institute of Urology and Transplantation