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

Not Applicable

Completed

Conditions: Cesarean Section; Complications, Wound, Dehiscence

Interventions: Device: Silver-impregnated antimicrobial dressing

Registration Number: NCT03136159

Lead Sponsor: Loyola University

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 380

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 >

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Silver-impregnated antimicrobial dressing	Silver-impregnated antimicrobial dressing	All participants undergoing primary cesarean section will receive a silver impregnated antimicrobial wound dressing (Mepilex Border AG), postoperative.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Wound Disruption and/or Infection	6 weeks postoperative	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

Secondary Outcome Measures