跳至主要内容
临床试验/NCT04042259
NCT04042259进行中(未招募)不适用

Delayed Primary Closure Using Negative Pressure Wound Therapy

Medical College of Wisconsin1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年8月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
30 day wound complication rate

研究概览

简要总结

Surgical site infection rates for contaminated or dirty laparotomy wounds can be as high as 45%. Surgical management of dirty and contaminated wounds has been controversial in the literature and between surgeons. Primary closure (PC) of these wounds can lead to multiple complications including surgical site infection (SSI), necrotizing soft tissue infection, wound and fascial dehiscence, evisceration, sepsis and hernia development. However, an alternative technique of utilizing secondary intention results in prolonged healing time and increased cost and healthcare resource utilization. Delayed primary closure (DPC) was developed to address many of these issues. Bhangu completed a systematic review and meta-analysis comparing primary versus delayed primary skin closure in contaminated and dirty abdominal wounds. They included 8 studies randomizing 623 patients with contaminated or dirty abdominal wounds to either DPC or PC. The most common diagnosis was appendicitis (77.4%), followed by perforated abdominal viscus (11.5%), ileostomy closure (6.5%), trauma (2.7%), and intra-abdominal abscess/other peritonitis (1.9%). The time to first assessment for DPC was between 2 and 5 days postoperatively. In all studies, the DPC group had significantly less SSIs using a fixed-effect model (odds ratio, 0.65; 95%CI, 0.40-0.93; P = .02). However, heterogeneity was high (72%), and using a random-effects model, the effect was no longer significant (odds ratio, 0.65; 95% CI, 0.25-1.64; P = .36). Additionally, all of the studies were found to be at high risk of bias, with marked deficiencies in study design and outcome assessment.

A recent systematic review showed improved fascial closure rates with negative pressure wound therapy (NPWT) Yet, a large national study using NPWT to perform a DPC has been shown to actually decrease the rate of closure. Access to NPWT has increased over the years and innovative wound management techniques including incisional application of negative pressure therapy have allowed clinicians to apply this method to dirty wounds following the principles of delayed primary closure. There are currently no studies available to help determine the safety and efficacy of advanced NPWT techniques to optimize surgical wound management from the open abdomen to skin closure. Within our Division, we have decided to make a practice change and develop a standard closure plan for open abdomens using the negative pressure devices available within our institution.

研究设计

研究类型
Interventional
分配方式
Non 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

入选标准

  • 18 years or older
  • undergone midline laparotomy and managed with an open abdomen for at least one day
  • contaminated or dirty wound classification

排除标准

  • Less than 18 years of age
  • Prisoners
  • Pregnant females
  • Non-surgical patients

研究组 & 干预措施

Negative Pressure Wound Therapy

Active Comparator

Standardized wound closure with negative pressure therapy.

干预措施: Abthera (Device)

Historic Cohort

Other

Historic cohort have undergone a midline laparotomy and managed with an open abdomen for at least one day and have contaminated or dirty wound classification.

干预措施: Open adbdomen for post-laparotomy without NPWT device (Procedure)

结局指标

主要结局

30 day wound complication rate

时间窗: 30 days

Wound infection, dehiscence, evisceration

30 day readmission

时间窗: 30 days

Patient discharged and readmitted to primary care

Cost of care

时间窗: days to wound closure an average of 30 days

Total cost for wound care

Closure of Skin

时间窗: 7 days

Measure of days to closure of skin

Days of Abthera, VERAFLO, and Prevena use

时间窗: through wound closure, an average of 30 days

Use of negative pressure wound therapy

Closure of Fascia

时间窗: 7 days

Measure of days to closure of fascia

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Colleen M Trevino PhD

Assistant Professor

Medical College of Wisconsin

研究点 (1)

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