Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery

Study Overview
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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).

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).

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

Conditions
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Cesarean Section Complications, Wound Breakdown, Wound Infection, Satisfaction, Surgical Wound Infection

Intervention / Treatment
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* Combination Product: ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG)
* Other: Standard Wound Care


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open label randomized control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard Wound Care<br>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. | Other: Standard Wound Care<br>* Wound care will be administered as standard protocol in our institution<br>|
| Active Comparator: CHG Wound Care<br>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. | Combination Product: ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG)<br>* Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7<br>* Other names: Dressing containing CHG a disinfectant and antiseptic that is used for skin disinfection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Postpartum wound care visit (up to 10days postpartum) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 30 days postpartum | 
| Number of Participants That Resulted in Maternal Death | Death of participant during hospital stay (Yes or No) | 4 days postpartum | 
| Number of Participants With Puerperal Fever | Temperature > 100.4oF after first 24 hours or ≥101 oF any time. (Yes or No) | 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. | Postpartum wound care visit (up to 10days postpartum) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean, Wound care, Wound complication, Surgical site infection