Randomized Controlled Trial of Panniculus Retraction Methods for Cesarean Delivery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 142
- Locations
- 4
- Primary Endpoint
- Cesarean delivery operative time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Fetal demise
- •Disruption of abdominal skin (infection, rash, abrasion, laceration)
- •Known adhesive allergy
Arms & Interventions
Traxi panniculus retraction group
The method of panniculus retraction will be the Traxi panniculus retraction (Clinical Innovations, LLC) by the provider.
Intervention: 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)
Outcomes
Primary Outcomes
Cesarean delivery operative time
Time Frame: through study completion, approximately 6 to 8 weeks
time from skin incision to closure during cesarean delivery
Secondary Outcomes
- 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)
Investigators
Ai-ris Collier
Principal Investigator
Beth Israel Deaconess Medical Center