The Effect of Traxi Panniculus Retractor on Surgical Time at Non-emergent Cesarean Delivery in Obese Women

Study Overview
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Brief Summary
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This is an unblinded, randomized control trial of obese women to evaluate the impact of the Traxi Panniculus Retractor (TPR) on the cesarean operative time and surgical blood loss when compared to silk tape.

Detailed Description
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The purpose of the study is to assess whether using the Traxi Panniculus Retractor during cesarean section, in obese (BMI greater than or equal to 30kg/m2 at time of delivery) women, can decrease the cesarean operative time compared to using silk tape to retract the panniculus. Operative time is defined as the time from when the patient lies on the operating room table (at completion of the epidural/spinal anesthesia) until fascial closure.

Official Title
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The Effect of Traxi Panniculus Retractor on Surgical Time at Non-emergent Cesarean Delivery in Obese Women

Conditions
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Obesity

Intervention / Treatment
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* Other: Traxi Panniculus Retractor (TPR)
* Other: Silk Tape


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current BMI equal to or greater than 30 kg/m2 at last prenatal visit or on day of admission to L&D Requires panniculus retractor for cesarean delivery, as determined by the surgeon Non-emergent cesarean delivery Spinal or epidural anesthesia Low transverse skin incision Gestational age equal to or more than 32 weeks 0 days Singleton pregnancy Three or less previous cesarean deliveries. English speaking Exclusion Criteria: Use of Alexis or any other retractor General anesthesia Fetal demise Placenta previa History of bariatric surgery Adhesive allergy
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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TPR Arm<br>Surgeon will use the Traxi Panniculus Retractor to retract the panniculus during cesarean section. | Other: Traxi Panniculus Retractor (TPR)<br>* Surgeon uses the Traxi Panniculus Retractor (TPR) surgical retraction device to retract the panniculus during C-Section.<br>|
| Active Comparator: Silk Tape Arm<br>Surgeon will use silk tape to retract the panniculus during cesarean section. | Other: Silk Tape<br>* Surgeon uses silk tape to retract the panniculus during C-Section.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from when a subject lies on the OR table to fascial closure |  | During surgery-Time from when a subject lies on the OR table to fascial closure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from skin incision to delivery |  | During surgery-skin incision to delivery | 
| Time from hysterotomy to delivery |  | During surgery-hysterotomy to delivery | 
| Time from skin incision to closure of fascia |  | During surgery-skin incision to closure of fascia | 
| Time from skin incision to skin closure |  | During surgery-skin incision to skin closure |