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

Not Applicable
Withdrawn
Conditions
Obesity
Registration Number
NCT04458415
Lead Sponsor
Geisinger Clinic
Brief Summary

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

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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
Female
Target Recruitment
Not specified
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Time from when a subject lies on the OR table to fascial closureDuring surgery-Time from when a subject lies on the OR table to fascial closure
Secondary Outcome Measures
NameTimeMethod
Time from skin incision to deliveryDuring surgery-skin incision to delivery
Time from hysterotomy to deliveryDuring surgery-hysterotomy to delivery
Time from skin incision to skin closureDuring surgery-skin incision to skin closure
Time from skin incision to closure of fasciaDuring surgery-skin incision to closure of fascia

Trial Locations

Locations (1)

Geisinger Medical Center

🇺🇸

Danville, Pennsylvania, United States

Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States

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