Trial record 3 of 8 for:    18090752 [PUBMED-IDS]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03136159
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : September 18, 2018
Molnlycke Health Care AB
Information provided by (Responsible Party):
Jean Goodman, 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.

Condition or disease Intervention/treatment Phase
Cesarean Section; Complications, Wound, Dehiscence Device: Silver-impregnated antimicrobial dressing Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 185 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Role of Adherent Occlusive Antimicrobial Absorbent Foam Dressing in Prevention of Cesarean Section Wound Complications
Actual Study Start Date : July 24, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Silver-impregnated antimicrobial dressing
All participants undergoing primary cesarean section will receive a silver impregnated antimicrobial wound dressing (Mepilex Border AG), postoperative.
Device: Silver-impregnated antimicrobial dressing
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 Name: Mepilex Border AG

Primary Outcome Measures :
  1. Wound complication rate [ Time Frame: 6 weeks postoperative ]
    Rate of wound disruption and /or infection occurring by 6 weeks will be compared to a historical control rate of 10%.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No

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 >

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03136159

Contact: Jean Goodman, MD 708-216-4033

United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Jean Goodman, MD    708-216-4033   
Sponsors and Collaborators
Loyola University
Molnlycke Health Care AB
Principal Investigator: Jean Goodman, MD Loyola University Chicago

Publications of Results:

Responsible Party: Jean Goodman, Director of Maternal Fetal Medicine, Loyola University Identifier: NCT03136159     History of Changes
Other Study ID Numbers: 207526
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jean Goodman, Loyola University:
cesarean section
wound healing
silver-containing dressing

Additional relevant MeSH terms:
Wounds and Injuries
Anti-Infective Agents
Anti-Bacterial Agents