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

August 4, 2021 updated by: Geisinger Clinic
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17821
        • Geisinger Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time from when a subject lies on the OR table to fascial closure
Time Frame: During surgery-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
Time Frame
Time from skin incision to delivery
Time Frame: During surgery-skin incision to delivery
During surgery-skin incision to delivery
Time from hysterotomy to delivery
Time Frame: During surgery-hysterotomy to delivery
During surgery-hysterotomy to delivery
Time from skin incision to closure of fascia
Time Frame: During surgery-skin incision to closure of fascia
During surgery-skin incision to closure of fascia
Time from skin incision to skin closure
Time Frame: During surgery-skin incision to skin closure
During surgery-skin incision to skin closure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geisinger Clinic

Collaborators

Clinical Innovations

Investigators

  • Principal Investigator: Michael J Paglia, MD, Geisinger Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

January 30, 2022

Study Completion (Anticipated)

April 30, 2022

Study Registration Dates

First Submitted

June 11, 2020

First Submitted That Met QC Criteria

June 30, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

August 11, 2021

Last Update Submitted That Met QC Criteria

August 4, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2020-0361

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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