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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-04-30

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.

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

No Masking

Study Groups

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TPR Arm

Surgeon will use the Traxi Panniculus Retractor to retract the panniculus during cesarean section.

Group Type EXPERIMENTAL

Traxi Panniculus Retractor (TPR)

Intervention Type OTHER

Surgeon uses the Traxi Panniculus Retractor (TPR) surgical retraction device to retract the panniculus during C-Section.

Silk Tape Arm

Surgeon will use silk tape to retract the panniculus during cesarean section.

Group Type ACTIVE_COMPARATOR

Silk Tape

Intervention Type OTHER

Surgeon uses silk tape to retract the panniculus during C-Section.

Interventions

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Traxi Panniculus Retractor (TPR)

Surgeon uses the Traxi Panniculus Retractor (TPR) surgical retraction device to retract the panniculus during C-Section.

Intervention Type OTHER

Silk Tape

Surgeon uses silk tape to retract the panniculus during C-Section.

Intervention Type OTHER

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