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Alexis O-Ring Wound Retractor for the Prevention of Post-cesarean Surgical Site Infections

NCT03365219 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 564

Last updated 2018-10-19

No results posted yet for this study

Summary

Post cesarean section surgical site infection (SSI) is a common complication that can affect patient recovery and overall outcome. Several approaches have been studied to improve SSI rates such as timing of antibiotic administration and skin preparation. Alexis retractors have been suggested as a reasonable option to decrease SSI. However, to date there is only one randomized controlled study assessing its efficacy. The aim of this study is to whether Alexis wound retractors are beneficial in preventing cesarean section SSI.

Conditions

  • Surgical Wound Infection

Interventions

DEVICE

Alexis O-Ring Wound Retractor

A flexible self-retaining plastic Alexis retractor was used in place of standard surgical retractors.

OTHER

Standard Surgical Retractors

Routine hand-held metal retractors as needed by the surgical team

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Gayle L Olson, MD · University of Texas Medical Branch in Galveston

  • George Saade, MD · University of Texas Medical Branch in Galveston

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-10-31
Completion
2013-10-31

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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 NCT03365219 on ClinicalTrials.gov