A Phase III Randomized Controlled Trial of Negative Pressure Wound Therapy in Post-Operative Incision Management
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 583
- 试验地点
- 19
- 主要终点
- Number of Post-op Wound Complications
研究概览
简要总结
The purpose of this study is to compare any good and bad effects of using the Prevena Incision Management System to using the usual standard dry gauze approach. The Prevena Incision Management System is a type of Negative Pressure Wound Therapy (NPWT). NPWT is a portable vacuum device made of a sponge-like foam that is applied over your incision to help draw fluid and debris out 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Criteria for Eligibility Prior to Surgery:
- •Women of any BMI undergoing a laparotomy procedure for a presumed gynecologic malignancy, or morbidly obese (BMI ≥ 40) women undergoing a laparotomy for any indication
- •or women who are morbidly obese (BMI>40) undergoing laparotomy for any indication
- •Criteria for Eligibility During Surgery:
- •Women of any BMI undergoing a laparotomy procedure for a presumed gynecologic malignancy, or morbidly obese (BMI ≥ 40) women undergoing a laparotomy for any indication
- •or women who are morbidly obese (BMI>40) undergoing laparotomy for any indication
排除标准
- •Exclusion prior to Surgery:
- •Women undergoing panniculectomy at the time of laparotomy
- •Women with sensitivity to silver
- •Exclusion during Surgery:
- •Women with laparotomy incisions left open due to case classification as "contaminated" or "dirty"
- •Women with laparotomy incisions unable to be closed primarily due to tissue or fascial damage
结局指标
主要结局
Number of Post-op Wound Complications
时间窗: 30 days +/- 5 days after surgery
Incidence of inpatient post-operative wound complications will be documented through the use of an inpatient data collection sheet. Incidence of outpatient post-operative wound complication will be documented through the use of an outpatient data collection sheet that will be completed by a provider at the time of the routine post-operative follow-up visit, which will occur at 30 days +/- 5 days after the day of surgery as well as through ongoing documentation of events as elicited through the institution's standard reporting system to collect information on enrolled patients.
次要结局
未报告次要终点