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临床试验/NCT05684198
NCT05684198已完成不适用

Emergency Laparotomy for Peritonitis and Surgical Site Infection: Preventive Subcutaneous NPWT vs Primary Closure - a Randomized Health Services Study

Medical University of Gdansk2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
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

入选标准

  • qualified for an emergency laparotomy for peritonitis
  • gave written informed consent

排除标准

  • qualified for open abdomen treatment

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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