Prevention of Abdominal Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Total Number of Patients Experiencing a Wound Complication
研究概览
简要总结
Wound complications after Cesarean section (C-section) are common in obese women. Approximately 25% of obese women having a C-section will have a wound complication. This research study is designed to assess whether applying a source of vacuum (suction) to the wound can reduce the risk of wound complications. The investigators plan to enroll 220 women into the study.
Women will be randomly selected to receive standard stitching and stapling of the incision (cut on the abdomen) or closure with stitches, staples and wound suction. Subjects will be seen for follow-up visits in 7-14 days and again at 4-6 weeks after surgery. The number of wound complications in each group will be compared. If the wound suction technique is successful in preventing wound complications, this may substantially reduce pain and suffering in a large number of women undergoing C-section for delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Undergoing Cesarean delivery.
- •Patient at least 18 years of age.
- •Weight greater than 199 pounds.
- •Depth of subcutaneous tissue (measured from fascia to epidermis) of greater than or equal to 4 centimeters.
排除标准
- •Weight less or equal to 199 pounds or less than 4 cm of subcutaneous tissue present.
- •Inability to give proper informed consent.
- •Inability to adhere to follow-up provisions of the study (return for 2 post-operative visits at 7-14 days post-op and between 4-6 weeks post-op).
- •Patient less than 18 years of age.
结局指标
主要结局
Total Number of Patients Experiencing a Wound Complication
时间窗: 6 Weeks post-partum
Superficial or deep space surgical site infection, or any type of wound disruption, including wound hematoma or seroma.
次要结局
未报告次要终点
研究者
Michael Stitely
Adjunct Associate Professor
West Virginia University