Prophylactic Negative Pressure Wound Therapy in Gynecologic Oncology: a Prospective Controlled Randomized Trial. (GO-VAC)
试验速览
- 阶段
- 不适用
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Change of the rate of surgical site infections at 15 days
研究概览
简要总结
A prospective controlled randomized study aimed to prospectively evaluate, the impact and effectiveness of clean incision prophylactic vacuum negative pressure therapy on wound healing (ciNPWT) in women at high risk of developing wound complications who undergo major gynecologic surgery.
Gynecologic Oncology patients appear to be more at risk of developing wound complications than the general surgery population, reaching infection rates of 36 vs. 24 % that become 40 and 60% for obese and morbidly obese patients, respectively. Data about the use of ciNPWT are few, controversial and are of poor quality. No randomized, controlled trials have yet been reported in support of the use of ciNPWT in the gynecologic population.
详细描述
Wound complications in patients undergoing surgery for malignancies have a negative impact on quality of life and, in addition, are associated with an increase of the duration of hospital stay, imparting a significant socio-economic burden.
Several approaches have been proposed to reduce the wound complications rate without success. Instead, a novel and promising method has been employed which utilizes prophylactic negative pressure wound therapy placed over clean and closed surgical incisions immediately after surgery (ciNPWT).
In a recent meta-analysis across studies including all types of wounds and surgeries, ciNPWT was observed to reduce by 29.4 % the incidence of SSI and the odds of SSI. In the same meta-analysis, while limiting attention to general abdominal surgery alone, the weighted average of the selected studies reported a reduction in wound complications of 10.43% (13.54% vs 23.97%) for the ciNPWT group compared with controls which was a significant benefit.
This study is a prospective multi-centre controlled randomized trial, where after gynecologic oncologic laparotomic surgery and standard abdominal wall closure (if inclusion criteria result satisfied), patient is randomized to one of the two arms of the study: ARM A (sperimental): ciNPWT ARM B ( control): standard dressing.
For women in arm A: prophylactic ciNPWT therapy entails placement of the device over a closed incision immediately post-operatively. The device may be left in place with no additional intervention for up to 7 days. The use of the device does not require specialty care services or continued hospitalization. For women in arm B: standard dressing should be changed every 2 days after sterile medication.
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
- Single (Investigator)
盲法说明
The investigator check the random list only when the patients is enrolled
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients subjected to midline incision (xiphoid-pubic/sub-xiphoid/umbilical-pubic incision) with:
- •Moderate/Severe (Aletti score ≥3) Modified surgical complexity score in:
- •Ovarian cancer: primary debulking surgery (PDS) or interval debulking surgery (IDS) (minimum total hysterectomy+bilateral salpingo-oophorectomy+lymphadenectomy in early ovarian cancer [EOC] should be done to include the patient in the trial) or secondary debulking surgery at recurrence (SCS).
- •Endometrial cancer FIGO stage IV or staging surgery for high risk endometrial cancer
- •Uterine Sarcomas FIGO stage IIB-IV
- •Previous history of pelvic or abdominal radiotherapy (even locally advanced cervical cancer [LACC] post neoadjuvant (NAD) therapies [NAD chemo-radiation or chemotherapy alone])
- •Persistent or recurrent Cervical cancer
- •Obesity (>30 Kg/sqm) in all Aletti score surgery and in all FIGO stage malignancies
- •Controlled diabetes mellitus in all Aletti score surgery and all FIGO stage malignancies
- •Heavy smokers ≥ 20 cigarettes a day in all Aletti score surgery and all FIGO stage malignancies.
排除标准
- •uncontrolled diabetes mellitus
- •severe cardiac dysfunction
- •pregnancy
- •underweight (body mass index [BMI] < 18.5 kg/sqm)
- •long-term steroid use
- •subcutaneous (e.g. Jackson Pratt) drainage positioning
- •post-operative prophylactic use of antibiotics beyond the intraoperative short therapy
- •contaminated (class III) and dirty/infected (class IV) incision [10]
- •allergy to silver
结局指标
主要结局
Change of the rate of surgical site infections at 15 days
时间窗: 15 days
To investigate whether the application of an ciNPWT device (Prevena Incision Management System, KCI, Inc., San Antonio, TX, USA) change the rate of surgical site infections (SSI) within 15 postoperative days in gynecologic oncology patients undergoing surgery, from 35 % to 15 %.
次要结局
- Estimated operative time(1 day)
- Estimated hospital stay(3-30 days)
- Antibiotic therapy estimate(30 days)
- Wound complications at 30 days(30 days)
- Time to start adjuvant therapy(30-50 days)
- Change of the rate of surgical site infections at 7 days(7 days)
研究者
Prof. Giovanni Scambia
Professor
Catholic University of the Sacred Heart