Traxi Panniculus Retractor for Cesarean Delivery
- Conditions
- Obesity, MorbidCesarean Section Complications
- Interventions
- Device: Traxi panniculus retraction (Clinical Innovations, LLC)
- Registration Number
- NCT03651076
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 141
- Pregnant
- 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
- Fetal demise
- Disruption of abdominal skin (infection, rash, abrasion, laceration)
- Known adhesive allergy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Traxi panniculus retraction group Traxi panniculus retraction (Clinical Innovations, LLC) The method of panniculus retraction will be the Traxi panniculus retraction (Clinical Innovations, LLC) by the provider.
- Primary Outcome Measures
Name Time Method Cesarean delivery operative time through study completion, approximately 6 to 8 weeks time from skin incision to closure during cesarean delivery
- Secondary Outcome Measures
Name Time Method Change in pulmonary function (forced vital capacity) through study completion, approximately 6 to 8 weeks measure difference in pulmonary function tests (FVC=forced vital capacity) before and after application of panniculus retraction method
Provider satisfaction with a survey through study completion, approximately 6 to 8 weeks provider-reported outcomes regarding surgery will be obtained using survey with an eleven level likert scale
Patient satisfaction assessed by a questionnaire through study completion, approximately 6 to 8 weeks patient-reported outcomes regarding surgery and delivery will be obtained using a survey made by the research team with a four level likert scale
Change in pulmonary function (forced expiratory volume) through study completion, approximately 6 to 8 weeks measure difference in pulmonary function tests (FEV1=forced expiratory volume in 1 minute) before and after application of panniculus retraction method
Trial Locations
- Locations (2)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States