Completed

Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Control Trial

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What is being tested

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

+ Standard Wound Care

Combination ProductOther
Who is being recruted

Behavior+6

+ Infections

+ Pathologic Processes

From 18 to 50 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: April 2019
See protocol details

Summary

Principal SponsorThe University of Texas Medical Branch, Galveston
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 18, 2019

Actual date on which the first participant was enrolled.

Subjects requiring cesarean delivery and without exclusion criteria will be informed by the obstetrical team about the study and asked for permission to contact the study personnel. Written informed consent will be obtained by person-to-person contact. The research staff will be responsible for the informed consent. Subjects who agree to participate in the study will be randomized to one of the two groups below in a 1/1 allocation: * Standard Wound Care: Wound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check. * CHG Wound Care: ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions (Appendix A) intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7. The remainder of the subjects' care will be similar for both arms and will follow current standard clinical practice at the University of Texas Medical Branch (UTMB).

Official TitleAntimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Control Trial
NCT03887299
Principal SponsorThe University of Texas Medical Branch, Galveston
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

154 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorInfectionsPathologic ProcessesPersonal SatisfactionPostoperative ComplicationsSurgical Wound DehiscenceSurgical Wound InfectionPathological Conditions, Signs and SymptomsWound Infection

Criteria

4 inclusion criteria required to participate
18-50 years of age.
Women ≥ 24 weeks' viable gestation.
To undergo cesarean delivery.
Admission BMI ≥ 35.
11 exclusion criteria prevent from participating
Patient unwilling or unable to provide consent.
No prenatal care or a non-resident patient who is unlikely to be followed-up after delivery.
Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4 <200, or other.
Decision not to have skin closure (e.g. secondary wound closure, mesh closure).
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7.

Group II

Placebo
Wound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Ashley Salazar

Galveston, United StatesOpen Ashley Salazar in Google Maps
CompletedOne Study Center