Subcutaneous Suture Versus no Subcutaneous Suture for Abdominal Wound Closure in Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 655
- 试验地点
- 1
研究概览
简要总结
Surgical site infections are among the most frequent complications after abdominal surgery and are associated with impaired wound healing, prolonged hospital stay, additional treatments, and increased healthcare costs. Closure of the subcutaneous tissue before skin closure is commonly performed in abdominal surgery, but the available evidence supporting this practice remains limited and heterogeneous, particularly outside caesarean section surgery.
The SUTURE trial is a prospective, randomized, patient- and assessor-blinded superiority trial evaluating whether subcutaneous tissue closure reduces the incidence of surgical site infections after abdominal surgery. Adult patients undergoing elective open or laparoscopically/robotically assisted abdominal surgery with an abdominal incision of at least 6 cm will be randomized intraoperatively after fascial closure to either subcutaneous tissue closure using interrupted Vicryl® 2-0 sutures or no subcutaneous tissue closure. The primary endpoint is the occurrence of surgical site infection according to CDC criteria grade I-II within 30 days after surgery.
The trial aims to provide high-quality evidence on whether routine subcutaneous tissue closure should be recommended as a standardized wound closure strategy in abdominal surgery.
详细描述
Surgical site infections (SSI) remain a common and clinically relevant complication after abdominal surgery. They may lead to delayed wound healing, postoperative pain, prolonged hospital stay, additional outpatient or inpatient wound care, antibiotic therapy, reoperations, reduced patient satisfaction, and increased healthcare costs. Despite improvements in perioperative care, SSI prevention remains an important target in abdominal surgery.
One potentially modifiable factor is the technique of abdominal wall closure, particularly whether the subcutaneous tissue is closed before skin closure. Subcutaneous suturing is frequently used in clinical practice, especially in patients with thicker subcutaneous tissue layers. However, the available evidence regarding routine subcutaneous tissue closure in non-caesarean abdominal surgery remains limited and heterogeneous. Therefore, high-quality randomized data are needed to clarify whether subcutaneous tissue closure reduces postoperative SSI after abdominal surgery.
The SUTURE trial is a prospective, randomized, patient- and assessor-blinded, single-center superiority trial conducted at the University Hospital Augsburg. Adult patients scheduled for elective abdominal surgery with an abdominal incision of at least 6 cm are eligible for screening. This includes open abdominal surgery as well as laparoscopically or robotically assisted procedures requiring specimen extraction through an abdominal incision of at least 6 cm.
Randomization is performed intraoperatively after fascial closure and before skin closure. Patients are allocated in a 1:1 ratio to either subcutaneous tissue closure or no subcutaneous tissue closure. In the intervention group, the subcutaneous tissue is closed using interrupted Vicryl® 2-0 sutures. In the control group, no subcutaneous sutures are placed before skin closure. Skin closure is performed according to the standardized institutional approach, using skin staples for open laparotomy and continuous intracutaneous Monocryl® 3-0 sutures for laparoscopically or robotically assisted procedures.
Patients and postoperative outcome assessors are blinded to treatment allocation. The operating surgeon cannot be blinded due to the nature of the intervention. Postoperative wound assessments are performed during the inpatient stay and at the predefined 30-day follow-up visit. The primary endpoint is the occurrence of SSI according to CDC criteria grade I-II within 30 days after 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (≥18 years)
- •elective laparotomy (midline laparotomy, transverse laparotomy, subcostal incision, thoracoabdominal incision, or extended Pfannenstiel incision) or laparoscopically assisted abdominal surgery with a specimen extraction incision of at least 6 cm.
排除标准
- •Emergency laparotomy.
- •Anticipated or documented non-compliance with study procedures or follow-up.
- •Patients in whom primary wound closure cannot be achieved at the end of surgery.
- •Patients unable to provide informed consent.
