WithdrawnNot Applicable

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

Stopped: Collaborator discontinued at this site to pursue the study with a different site.

United States0Started 2021-06-01

Plain-language 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.

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Time from when a subject lies on the OR table to fascial closure

Timeframe: During surgery-Time from when a subject lies on the OR table to fascial closure

Trial details

NCT IDNCT04458415

SponsorGeisinger Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-30

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