跳至主要内容
临床试验/NCT02309944
NCT02309944已完成不适用

Negative Pressure Wound Therapy in Obese Gynecologic Oncology Patients: A Randomized Controlled Trial

Masonic Cancer Center, University of Minnesota2 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
2
主要终点
Number of Participants Who Experience Wound Complications (Wound Dehiscence or Infection)

研究概览

简要总结

The purpose of the study is to test whether the use of a new wound closure technique can decrease the rates of wound complications in obese cancer patients.

详细描述

Most gynecologic and many intra-abdominal malignancies are treated with an initial surgical procedure. There has been a dramatic increase in obesity rates in the US with more than one third of US adults being obese (Body Mass Index (BMI) of > 30kg/m2). There is a direct link between obesity and wound complications following surgery with an increasing BMI leading to increasing rates of complications. Negative pressure wound therapy (NPWT) is a system that utilizes sub-atmospheric pressure to improve wound healing by increasing the formation of granulation tissue. NPWT has been shown to improve outcomes in both the orthopedic and cardiothoracic surgery populations. To date, there is no prospective study evaluating the application of prophylactic NPWT in laparotomy patients.

This study will be a randomized clinical trial. Patients will be enrolled at the time of consent for laparotomy for suspected gynecologic malignancy. Participants will be randomized to one of two groups: 1) Standard closure group (control arm): closure of the fascia, subcutaneous tissue and skin per the surgeon's standard method; or 2) NPWT group (study arm): closure of the fascia, subcutaneous tissue and skin per the surgeon's standard method + placement of a negative pressure wound therapy device over the closed incision for 2-3 days, with removal of the device prior to hospital discharge. The rate of wound complications for two groups will be compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • Known or suspected gynecologic or other abdominal malignancy (such as colorectal, liver, pancreatic, kidney and stomach) for which laparotomy is planned
  • Obese - defined as a Body Mass Index (BMI) ≥ 35 kg/m2 as calculated in the Epic computer record

排除标准

  • Known true tape allergy
  • Sensitivity to silver
  • History of intolerance to Negative Pressure Wound Therapy

结局指标

主要结局

Number of Participants Who Experience Wound Complications (Wound Dehiscence or Infection)

时间窗: one month after surgery

次要结局

  • Time From Surgery to Starting Adjuvant Therapy Among Those With Confirmed Malignancies(up to 20 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验