Traxi Panniculus Retractor for Cesarean Delivery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trial of Panniculus Retraction Methods for Cesarean Delivery

Conditions
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Obesity, Morbid, Cesarean Section Complications

Intervention / Treatment
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* Device: Traxi panniculus retraction (Clinical Innovations, LLC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Fetal demise Disruption of abdominal skin (infection, rash, abrasion, laceration) Known adhesive allergy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traxi panniculus retraction group<br>The method of panniculus retraction will be the Traxi panniculus retraction (Clinical Innovations, LLC) by the provider. | Device: Traxi panniculus retraction (Clinical Innovations, LLC)<br>* class I, FDA-exempt, commercially available for use in panniculus retraction during cesarean delivery or other laparotomy<br>|
| No Intervention: Standard of care<br>Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarean delivery operative time | time from skin incision to closure during cesarean delivery | through study completion, approximately 6 to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | through study completion, approximately 6 to 8 weeks |