Obesity
Conditions
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.
Interventions
OTHERTraxi Panniculus Retractor (TPR)
Surgeon uses the Traxi Panniculus Retractor (TPR) surgical retraction device to retract the panniculus during C-Section.
OTHERSilk Tape
Surgeon uses silk tape to retract the panniculus during C-Section.
Sponsors
Clinical Innovations
Geisinger Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
No Masking
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed