The Incidence of Surgical Site Complications in Transverse Versus Longitudinal Groin Incision in Vascular Surgery: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 232
- 试验地点
- 2
- 主要终点
- Incidence of surgical site complications
研究概览
简要总结
The purpose of the study is to examine whether incision type has an influence on the development of groin wound complications after operation in the groin in vascular surgery.
The main questions it aims to answer are:
Does a transverse incision in the groin lead to fewer surgical site complications than a longitudinal incision? Does a transverse incision lead to fewer readmissions, fewer reoperations, shorter length of hospital stay, and a lower amputation rate.
Participants will undergo vascular surgery in the groin with either a transverse or longitudinal incision. The incision type will be selected randomly.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing vascular reconstruction with a groin incision
排除标准
- •Patients previously operated with a groin incision.
- •Patients undergoing operation due to trauma, bleeding, or pseudoaneurysm.
- •Patients operated within the first 24 hours of admission.
- •If it prior to the operation is deemed necessary with a muscleplasty.
结局指标
主要结局
Incidence of surgical site complications
时间窗: 35 days after the operation
The surgical site complications are defined as follows: * Surgical site infection according to the Szilagy classification: * Dehiscence with separation of the wound edges and exposure of the underlying tissue. * Lymhocele defined as the presence of localized swelling in the groin and verified on ultrasound as an anechoic fluid collection. * Hematoma defined as the presence of localized swelling in the groin with discoloration and verified on ultrasound as an echoic fluid collection.
次要结局
- Reoperation(35 days after the operation)
- Readmission(35 days)
- • Length of stay(35 days)
- Mortality(35 days)
- Healing of the groin(35 days)
研究者
Christina Pilgaard Madsen
MD, PhD-student
Kolding Sygehus