Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery

The University of Texas Medical Branch, Galveston154 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

154

Conditions

Cesarean Section Complications Wound Breakdown Wound Infection Satisfaction Surgical Wound Infection

Interventions

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

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

Standard Wound CareOTHER

Wound care will be administered as standard protocol in our institution

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Ashley Salazar

Galveston, Texas, United States

Outcomes

Primary Outcomes

Satisfaction and QoL Questionnaire

We will be assessing through a survey patient satisfaction concerning dressing received and assess the quality of life while receiving either intervention (5 point Richter scale). A maximum score of 5: Strongly agree and a minimum score of 1: Strongly disagree. A higher score means a better outcome.

Time frame: Postpartum wound care visit (up to 10days postpartum)

Secondary Outcomes

Number of Participants With Composite Wound Complication

Defined as presence of any of the following within 30 days from surgery: Wound infection: Presence of either superficial or deep incisional SSI described as cellulitis/erythema and induration around the incision or purulent discharge from the incision site, with or without fever, such as necrotizing fasciitis (diagnosed based on necrotizing wound infection). Wound hematoma, seroma, or breakdown alone. (yes or No)

Time frame: 30 days postpartum

Number of Participants With Wound Breakdown

Opening of wound incision documented in the chart at the provider's discretion(Yes or No)

Time frame: 30 days postpartum

Number of Participants That Resulted in Maternal Death

Death of participant during hospital stay (Yes or No)

Time frame: 4 days postpartum

Number of Participants With Puerperal Fever

Temperature \> 100.4oF after first 24 hours or ≥101 oF any time. (Yes or No)

Time frame: 4 days postpartum

Provider Satisfaction

Assessing health care providers opinion on the dressing care (5 point Richter scale). A maximum score of 5: Strongly agree and a minimum score of 1: Strongly disagree. A higher score means a better outcome.

Data from ClinicalTrials.gov

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