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

Loyola University

Status: Completed

Conditions: Cesarean Section; Complications, Wound, Dehiscence

Treatments: Device: Silver-impregnated antimicrobial dressing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03136159

207526

Details and patient eligibility

About

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.

Full 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.

Enrollment: 380 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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 >

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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380 participants in 1 patient group

Silver-impregnated antimicrobial dressing

Experimental group

Description:

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

Treatment:

Device: Silver-impregnated antimicrobial dressing