CLOSM Trial: Groin Closure Using Layered Option for Suture Material
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 259
- 试验地点
- 1
- 主要终点
- Rate of groin complication
研究概览
简要总结
This is a randomized controlled trial comparing groin closure after vascular intervention with Vicryl suture versus PDS (polydioxanone) suture. This will be a single center trail performed at CCF main campus. Patients will be enrolled in a prospective fashion and will be randomized 1:1 to either PDS or Vicryl closure. Patients undergoing bilateral groin exposure will be randomized to receive both closure types to either groin.
详细描述
Previous research has provided insights into the properties of various suture materials, yet there remains a gap in our understanding of their relative effectiveness in groin closure specifically within the context of vascular surgery. The lack of definitive evidence on whether Vicryl or PDS (polydioxanone) sutures offer superior outcomes necessitates further investigation. This study aims to address this gap by conducting a head-to-head comparison of these sutures, focusing on their impact on postoperative groin complications.
This is a randomized controlled trial comparing groin closure after vascular intervention with Vicryl versus PDS. This will be a single center trail performed at CCF main campus. Patients will be enrolled in a prospective fashion and will be randomized 1:1 to either PDS or Vicryl closure. Patients undergoing bilateral groin exposure will be randomized to receive both closure types to either groin.
The primary objective of this randomized controlled trial (RCT) is to evaluate the effectiveness of Vicryl versus PDS sutures in reducing groin complications following vascular surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients > 18 years who undergo ELECTIVE vascular surgery that would require groin incisions
- •Patients with to undergo ELECTIVE bilateral groin incisions will be matched to receive closure with PDS in one groin and Vicryl in the other groin
排除标准
- •Age 17 or younger
- •Pregnant patients
- •Emergent cases
- •Active groin infection prior to intervention
- •History of prior surgical groin access (re-operative groin)
- •Groin closure after extracorporeal membrane oxygenation (ECMO)
研究组 & 干预措施
Groin closure after vascular intervention with PDS suture
Vascular intervention access site closed with PDS suture
干预措施: Groin closure with PDS suture (Procedure)
Groin closure after vascular intervention with Vicryl suture
Vascular intervention access site closure with Vicryl suture
干预措施: Groin closure suture material (Procedure)
结局指标
主要结局
Rate of groin complication
时间窗: 30 days and 1 year
Number of occurrence of the access site complication
次要结局
未报告次要终点
研究者
Francis Caputo, MD
Principal Investigator
The Cleveland Clinic