Randomized Controlled Trial of Panniculus Retraction Methods for Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 142
- 试验地点
- 4
- 主要终点
- Cesarean delivery operative time
研究概览
简要总结
This prospective, open-label, randomized-controlled trial is designed to evaluate the use of the Traxi panniculus retractor-- a commercially available Class I FDA-exempt device will improve surgical outcomes, cardiopulmonary function, and provider/patient satisfaction in morbidly obese women undergoing cesarean delivery.
详细描述
Morbidly obese women (BMI >/= 40) undergoing non-emergent cesarean delivery will be recruited and randomized to Traxi panniculus retraction or standard of care for panniculus retraction.
The primary outcome evaluated will be operating time (incision to closure). Other secondary outcomes related to surgery including estimated blood loss, surgical site infection, and number of scrubbed personnel.
A secondary aim of the study is to evaluate the hypothesis that the Traxi retraction device reduces chestwall compression panniculus retraction and will improve intraoperative pulmonary function. To do this, the investigators will measure the difference in individual participant pulmonary function tests (forced vital capacity, forced expiratory volume) before and after panniculus retraction using a bedside spirometer.
A tertiary aim of the study is to evaluate the hypothesis that the Traxi retraction device will improve patient and provider satisfaction due to improved delivery experience and maintaining patient dignity. Patient and provider-reported outcomes will be evaluated using surveys.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BMI greater than or equal to 40 kg/m^2
- •Undergoing non-emergent cesarean delivery
- •Able and willing to provide written, informed consent
- •Singleton gestation
排除标准
- •Fetal demise
- •Disruption of abdominal skin (infection, rash, abrasion, laceration)
- •Known adhesive allergy
研究组 & 干预措施
Traxi panniculus retraction group
The method of panniculus retraction will be the Traxi panniculus retraction (Clinical Innovations, LLC) by the provider.
干预措施: Traxi panniculus retraction (Clinical Innovations, LLC) (Device)
Standard of care
Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction)
结局指标
主要结局
Cesarean delivery operative time
时间窗: through study completion, approximately 6 to 8 weeks
time from skin incision to closure during cesarean delivery
次要结局
- Change in pulmonary function (forced vital capacity)(through study completion, approximately 6 to 8 weeks)
- Provider satisfaction with a survey(through study completion, approximately 6 to 8 weeks)
- Patient satisfaction assessed by a questionnaire(through study completion, approximately 6 to 8 weeks)
- Change in pulmonary function (forced expiratory volume)(through study completion, approximately 6 to 8 weeks)
研究者
Ai-ris Collier
Principal Investigator
Beth Israel Deaconess Medical Center