Negative Pressure Wound Therapy in High Risk Patients Undergoing Cesarean
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 441
- 试验地点
- 2
- 主要终点
- Number of Participants With Wound Complication
研究概览
简要总结
The investigators propose a prospective, randomized trial evaluating the use of negative pressure wound therapy (NPWT) with high risk obstetrical patients. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators aim to look at all wound complications such as infection and disruption and will be using Prevena incision management system for our NPWT device .
详细描述
This will be a prospective, randomized, controlled trial of pregnant women who present for prenatal care at Parkland Health and Hospital System. The participants will be limited to women undergoing a cesarean section who are high risk for wound complications: all patients with a BMI > 40 undergoing cesarean section.
The primary outcome will be wound complication defined as wound disruption or wound infection. A wound disruption will be defined as the partial or complete opening of the deep subcutaneous space, not to include superficial skin separation. Underlying causes will include seroma, hematoma, abscess, and facial dehiscence. Wound infection will be defined as a physician diagnosis of wound infection with erythema and warmth extending beyond the immediate area adjacent to the incision and requiring treatment with antibiotics.
All patients with a BMI > 40 undergoing scheduled cesarean section and patients with a BMI >40 who are admitted in labor will be approached to participate in the study. If patients meeting this criteria undergo cesarean section, they will be randomized to negative pressure wound therapy or a standard dressing. All labor treatment, pre-operative antibiotics, surgical technique, and post-operative care will not differ from current standard of care. All patients randomized will be included in the study.
All study participants will have the thickness of their subcutaneous tissue measured with a sterile ruler. Patients randomized to NPWT will have a negative pressure wound therapy system placed over her incision per the manufacturer's protocol. All patients randomized to standard dressing will have the customary dressing of gauze and surgical tape placed over her incision.
The investigators will be utilizing a single use negative pressure wound therapy system for the study. Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use.
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
- 10 Years 至 64 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women with BMI > 40 undergoing a cesarean delivery at Parkland Health and Hospital System.
排除标准
- •Any patient not meeting inclusion criteria will be deemed ineligible.
- •All HIV positive patients will be excluded due to the increased risk of infectious complications in these patients.
- •Although patients on anticoagulants can use NPWT, they will be excluded as there may be an increased risk of bleeding in these patients.
- •according to the wound therapy manufacturer's instructions patients with:
- •fragile skin
- •allergy to silver or acrylic adhesives
- •a malignancy in the wound bed or margins of the wound bed
- •non-enteric and unexplored fistulas
- •necrotic tissue with eschar present
- •exposed arteries, veins, nerves or organs, anastomotic sites, or surgical suction are not candidates for usage of the device.
结局指标
主要结局
Number of Participants With Wound Complication
时间窗: Day of surgery to 30 days postoperative
Number of Patients with Wound infection complications: hematoma, seroma, dehiscence, or Surgical Site Infection.
Number of Participants With Classification of Wound Morbidity
时间窗: Day of Surgery to 30 days postoperative
Listing of different types of wound morbidity in the 2 cohorts: dehiscence, cellulitis, superficial SSI, deep SSI, organ space SSI
次要结局
- Number of Patients With Emergency Room Visits After Discharge(Day of surgery to 30 days postoperative)
- Number of Participants With Pfannenstiel Versus Midline Abdominal Incisions for Cesarian Section(Day of Surgery to 30 days postoperative)
- Number of Patients in Labor Versus no Labor Prior to Cesarean Section(Day of Surgery to 30 days postoperative)
- Number of Patients With Hypertension Versus no Hypertension(Day of Surgery to 30 days postoperative)
- Length of Stay After Readmission(After dismissal and readmitted within 30 days for wound morbidity)
- Number of Patients With Ruptured and Unruptured Membranes Prior to Cesarean Section(Day of Surgery to 30 days postoperative)
- Number of Patients With Insulin Requiring Diabetes Versus no Insulin Requiring Diabetes(Day of Surgery to 30 days postoperative)
- Number of Patients With Chorioamnionitis Versus no Chorioamnionitis(Day of Surgery to 30 days postoperative)
- Number of Patients With Number of Clinic Visits(Day of surgery to 30 days postoperative)
- Number of Participants With Morbid Outcomes After Delivery(Day of Surgery to 30 days postoperative)
- Number of Participants With Scheduled and Unscheduled Cesarean Section(Day of Surgery to 30 days postoperative)
- Length of Postoperative Stay(Length of Postoperative Stay)