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The Effect of a Self-Retaining Pannus Retractor in Obese Patients Undergoing Cesarean Section

NCT02865083 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-06-04

Study results available
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Summary

The purpose of this study is to investigate the effects of the Traxi Pannus retractor in obese patients (BMI ≥30 kg/m2) who undergo Cesarean sections compared to routine pannus retraction techniques. Patients will be randomized to the use of the Traxi retractor during Cesarean section (treatment group) or the use of traditional pannus retraction techniques (control group). The primary outcome to be followed is surgical site disruption. The investigators will also assess the duration of surgery or length of time from skin incision to delivery of the infant, change in hemoglobin, estimated blood loss, postoperative length of stay, need for hospital readmission or emergency room visits, or other complication rates between the two groups.

Conditions

  • Obese Patients Undergoing Cesarean Section

Interventions

DEVICE

Traxi Pannus Retractor

traxi® Panniculus Retractor is a retraction device used for retraction of the panniculus during surgical procedures. traxi retracts and holds the panniculus for the duration of the operation, freeing the surgeons hands and those of the staff to better care for the patient.

Sponsors & Collaborators

  • St. Louis University

    lead OTHER

Principal Investigators

  • Jennifer Goldkamp, MD · St. Louis University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2017-01-02
Completion
2017-01-02

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02865083 on ClinicalTrials.gov