Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-18

Study Completion Date

2020-02-28

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Cesarean Section Complications Wound Breakdown Wound Infection Satisfaction Surgical Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open label randomized control trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Data analysis will be blinded to assignment including the principal investigator.

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Standard Wound Care

Intervention Type OTHER

Wound care will be administered as standard protocol in our institution

CHG Wound Care

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 Type ACTIVE_COMPARATOR

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

Intervention Type COMBINATION_PRODUCT

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

Interventions

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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

Intervention Type COMBINATION_PRODUCT

Standard Wound Care

Wound care will be administered as standard protocol in our institution

Intervention Type OTHER

Other Intervention Names

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Dressing containing CHG a disinfectant and antiseptic that is used for skin disinfection

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes