Suturing Smarter: Closure of Midline Laparotomy Using Barbed Polydioxanone Versus Conventional Polydioxanone – A Randomized Controlled Study
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of wound dehiscence or SSI within 10 postoperative days
研究概览
简要总结
Midline laparotomy is widely used in abdominal surgeries, and proper abdominal wall closure is essential to prevent complications like surgical site infections, wound dehiscence, incisional hernias, and prolonged hospital stays. Traditionally, absorbable mnofilament sutures like polydioxanone (PDS) have been used for closure. Barbed sutures, which self-anchor without knots, offer potential benefits such as even tension distribution and reduced closure time. However, despite growing use, especially in laparoscopic and open procedures, there is limited high-quality evidence comparing barbed and traditional sutures—particularly in the Indian population. Concerns persist about barbed sutures’ long-term durability, cost-effectiveness, and risk of tissue trauma. This study seeks to fill these gaps through a rigorous randomized controlled trial
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •Previous midline incision, ventral hernia- now planned only herniorrhaphy Written informed consent.
排除标准
- •Emergency laparotomy Immunocompromised states Diabetes with poor glycemic control HbA1c over 8.5 Pregnant patients.
结局指标
主要结局
Incidence of wound dehiscence or SSI within 10 postoperative days
时间窗: Incidence of wound dehiscence or SSI within 10 postoperative days
次要结局
- 1) Operative time for fascial closure (minutes) 2) Postoperative pain (VAS score) on POD 1, 3, 5 3) Incisional hernia at 3months, 6 months & 1 year (clinical & ultrasonographic evaluation) 4) Direct cost of suture material(Postoperative pain (VAS score) on POD 1, 3, 5 3))
研究者
DR LAVU JAYANTH
AIIMS MANGALAGIRI
