跳至主要内容
临床试验/CTRI/2025/08/093507
CTRI/2025/08/093507已完成Unknown

Suturing Smarter: Closure of Midline Laparotomy Using Barbed Polydioxanone Versus Conventional Polydioxanone – A Randomized Controlled Study

DR LAVU JAYANTH1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月26日最近更新:

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

发起方
DR LAVU JAYANTH
申办方类型
Other [SELF FUNDED]
责任方
Principal Investigator
主要研究者

DR LAVU JAYANTH

AIIMS MANGALAGIRI

研究点 (1)

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