The Role of Antimicrobial Foam Dressing in Prevention of Cesarean Section Wound Complications

Study Overview
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Brief Summary
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Post-cesarean section wound infections are responsible for longer hospital stays, readmissions, and ultimately, increased costs to the healthcare system. Silver-containing dressings may prevent wound infections. The purpose of the current study is to determine if the use of a silver-impregnated dressing decreases the occurence of wound infection following cesarean delivery.

Detailed Description
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A single-centered, single-arm clinical trial was originally designed to investigate the effects of an adherent soft silicone anti-microbial occlusive foam silver-impregnated dressing in preventing surgical site infection (SSI) in women delivered by primary cesarean section (CS). We sought to determine if the incidence of SSIs, would be lower in patients who received a silver-impregnated dressing as compared to those who received a standard dressing, when used as part of the overall hospital protocol for reducing SSIs. Given the addition of adjunctive azithromycin antibiotic prophylaxis for those who labored or had rupture of membranes prior to undergoing a non-elective CS right at the time of initiation of the study to our institution perioperative bundle, we also elected to undertake further analyses of observational data on those with the same study inclusion criteria receiving standard dressing undergoing primary CS with subcuticular skin closure during the same time period, rather than limiting comparisons of our outcomes solely to our historical SSI rates. In order to have this comparison group, patients who declined participation in the experimental groups were selected as our non-randomized control group, given fiscal restraints precluded conducting a randomized clinical trial (RCT). Demographic, labor, delivery, intraoperative and postoperative characteristic data were collected in a de-identified fashion. Medical record review and data entry were conducted by trained research personnel. All study procedures were approved by the Investigational Review Board.

Official Title
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The Role of Adherent Occlusive Antimicrobial Absorbent Foam Dressing in Prevention of Cesarean Section Wound Complications

Conditions
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Cesarean Section; Complications, Wound, Dehiscence

Intervention / Treatment
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* Device: Silver-impregnated antimicrobial dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consent to undergo cesarean delivery Between the ages of 18 and 45 Primary C-section Subcuticular skin closure Able to consent, fill out study documents, and complete all study procedures and follow-up visits Exclusion Criteria: Patients with an allergy to silver Inability to obtain informed consent Staples Repeat C-section Vertical skin incision Intrapartum fever of 100F or >

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silver-impregnated antimicrobial dressing<br>All participants undergoing primary cesarean section will receive a silver impregnated antimicrobial wound dressing (Mepilex Border AG), postoperative. | Device: Silver-impregnated antimicrobial dressing<br>* All participants will receive an adherent soft silicone silver impregnated anti-microbial occlusive foam dressing after cesarean section. The dressing will stay on for up to seven days.<br>* Other names: Mepilex Border AG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Wound Disruption and/or Infection | Rate of wound disruption and /or infection occurring by 6 weeks was compared to a historical control rate of 10%, and to a contemporary group who received a standard dressing | 6 weeks postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound healing, silver-containing dressing, pregnancy, delivery, cesarean section