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Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery

NCT03887299 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2021-10-05

Study results available
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Summary

This will be an open label pilot randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have standard wound dressing care or chlorohexidine gluconate (CHG) impregnated wound dressing (ReliaTect™ Post-Op Dressing).

Conditions

  • Cesarean Section Complications
  • Wound Breakdown
  • Wound Infection
  • Satisfaction
  • Surgical Wound Infection

Interventions

COMBINATION_PRODUCT

ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG)

Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7

OTHER

Standard Wound Care

Wound care will be administered as standard protocol in our institution

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Antonio F. Saad, MD · UTMB Galveston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-18
Primary Completion
2020-01-18
Completion
2020-02-28
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03887299 on ClinicalTrials.gov