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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
141
class I, FDA-exempt, commercially available for use in panniculus retraction during cesarean delivery or other laparotomy
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Cesarean delivery operative time
time from skin incision to closure during cesarean delivery
Time frame: through study completion, approximately 6 to 8 weeks
Change in pulmonary function (forced vital capacity)
measure difference in pulmonary function tests (FVC=forced vital capacity) before and after application of panniculus retraction method
Time frame: through study completion, approximately 6 to 8 weeks
Change in pulmonary function (forced expiratory volume)
measure difference in pulmonary function tests (FEV1=forced expiratory volume in 1 minute) before and after application of panniculus retraction method
Time frame: through study completion, approximately 6 to 8 weeks
Patient satisfaction assessed by a questionnaire
patient-reported outcomes regarding surgery and delivery will be obtained using a survey made by the research team with a four level likert scale
Time frame: through study completion, approximately 6 to 8 weeks
Provider satisfaction with a survey
provider-reported outcomes regarding surgery will be obtained using survey with an eleven level likert scale
Time frame: through study completion, approximately 6 to 8 weeks
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