Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery



Status:Not yet recruiting
Conditions:Infectious Disease, Hospital, Hospital
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:18 - 50
Updated:3/24/2019
Start Date:April 1, 2019
End Date:July 31, 2020
Contact:Antonio Saad, MD
Email:afsaad@utmb.edu
Phone:409 7772 0982

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

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).

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).

Inclusion Criteria:

- 18-50 years of age.

- Women ≥ 24 weeks' viable gestation.

- To undergo cesarean delivery.

- Admission BMI ≥ 35.

Exclusion Criteria:

- 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).

- Current skin infection.

- Coagulopathy.

- High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled
hysterectomy, bowel or adnexal surgery).

- Known allergy to CHG.

- Incarcerated individuals.

- Chorioamnionitis.

- Subjects participating on other treatment trials or studies that would interfere with
the current study's primary outcome.
We found this trial at
1
site
Galveston, Texas 77555
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Galveston, TX
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