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Self-Retaining Retractor in Obese Patients Undergoing Cesarean Section

NCT01826604 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2016-10-03

Study results available
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Summary

The purpose of this study is to investigate the effects of the Alexis O C-section retractor in obese patients (BMI ≥30 kg/m2) who undergo Cesarean sections. Patients will be randomized to the use of the Alexis retractor during Cesarean section (treatment group) or the use of traditional hand-held retractors (control group). We will determine if there is any difference in surgical site infection or wound disruption rates. We will also determine if there is a difference in the duration of surgery or length of time from skin incision to delivery of the infant, change in hemoglobin, estimated blood loss, and postoperative length of stay, intra-operative or postoperative anti-emetic requirements, need for hospital readmission or emergency room visits, or other complication rate between the two groups.

Conditions

Interventions

DEVICE

Alexis O C-Section Retractor

The Alexis O C-section retractor will be used.

OTHER

Control- Conventional retractors

Conventional hand-held retractors will be used. A self-retaining barrier retractor will not be used.

Sponsors & Collaborators

  • St. Louis University

    lead OTHER

Principal Investigators

  • Katherine Scolari Childress, M.D. · St. Louis University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01826604 on ClinicalTrials.gov