Emergency Laparotomy for Peritonitis and Surgical Site Infection: Preventive Subcutaneous NPWT vs Primary Closure - a Randomized Health Services Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time to end of surgical treatment of the wound
研究概览
简要总结
The study aims to evaluate the efficacy of negative pressure wound therapy (NPWT) compared with primary closure (PC) in surgical site infection (SSI) prevention for laparotomy for peritonitis.
详细描述
Surgical site infection is a particularly common morbidity in contaminated surgeries leading to prolonged length of hospital stay, healing time, and a significant financial burden on healthcare systems.
Hence, the objective of PRISTINE trial is to compare the effectiveness of subcutaneous NPWT with PC for SSI prevention in patients who, due to wound contamination, are prone to infection. Moreover, with a further cost analysis, the investigators aim to evaluate the rationale for the implementation of routine preventive NPWT for laparotomy for diffuse peritonitis.
Patients qualified for an emergency laparotomy for peritonitis in University Clinical Centre (UCC) Division of Oncological, Endocrine and General Surgery will be identified. Prior to laparotomy, participants will be randomized in 1:1 ratio to subcutaneous NPWT or PC. The assigned intervention will be performed intraoperatively, after fascia closure.
All participants will receive an empirical antibiotic therapy regimen consisting of tazobactam/piperacillin or ciprofloxacin+ metronidazole. Participants will be followed-up postoperatively for one year.
In case of an SSI all participants, regardless of their initial allocation, will be treated according to the standard of care with prolonged NPWT and targeted antibiotic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •qualified for an emergency laparotomy for peritonitis
- •gave written informed consent
排除标准
- •qualified for open abdomen treatment
研究组 & 干预措施
subcutaneous NPWT
The peritoneum and fascia will be closed as in the PC arm. Subsequently, patients will be treated with commercially available vacuum-assisted closure systems (provided by Smith&Nephew or Hartmann) according to the manufacturer's instructions. Following fascia closure, the NPWT foam will be adjusted to the wound size to fill the wound cavity without causing excessive wound dehiscence. Subsequently, the foam will be placed in the subcutaneous tissue. The foam will not be fixated on the skin with sutures. The wound will be sealed with adhesive film. In case of air leak in problematic areas such as the navel or ostomy, ostomy paste will be used to create a tighter seal. Continuous pressure of 120 mmHg will be applied. On the 3rd day postop, the dressing will be removed and closure by secondary intention will be performed.
干预措施: subcutaneous NPWT (Device)
primary closure
The peritoneum will be closed as a separate layer with a 2-0 multifilament absorbable suture. Subsequently, the fascia will be closed with a continuous suture using absorbable monofilament 0 sutures. Subcutaneous tissue will be rinsed twice with hypochlorite solution following peritoneal closure and fascial closure. Interrupted subcutaneous closure will be performed with absorbable multifilament 2-0 sutures. Following skin disinfection with an alcohol solution, the skin will be closed with non-absorbable monofilament 2-0 or 3-0 sutures using the interrupted mattress technique. Conventional Cosmopor® sterile gauze dressings will be applied. Unless the dressing material will be saturated, the dressing will remain unchanged until 3rd day post-op.
结局指标
主要结局
Time to end of surgical treatment of the wound
时间窗: 1 year
Time of last out-patient visit ending the process of treating surgical wound
Effective wound closure by 30th day post-op
时间窗: 30 days
definitive wound closure, not followed by secondary wound dehiscence
次要结局
- Time of secondary NPWT treatment(60 days)
- SSI presence or absence(30 days)
- Length of stay(90 days)
- Time to heal(120 days)
- Scar quality(1 year)
- Volume of wound drainage(60 days)
- Post-operative morbidity(60 days)
- Pain level(7 days)
- Cost(1 year)