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OpenTrials
Completed

NCT Number: NCT03136159

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

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.

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Key information

Conditions

Cesarean Section; Complications, Wound, Dehiscence Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 >

Treatment and study plan

Silver-impregnated antimicrobial dressing

Device

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.

Other names: Mepilex Border AG

Primary outcomes

  1. Number of Participants With Wound Disruption and/or Infection

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Collaborators

  • Molnlycke Health Care AB

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 2, 2017
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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