Topical Silver for Prevention of Wound Infection After Cesarean Delivery

April 19, 2017 updated by: Kelly Bennett, Vanderbilt University

Topical Silver for Prevention of Wound Infection Post Cesarean Delivery: A Randomized Controlled Trial

A common concern in any surgical procedure is the occurrence of infection. Silver-containing treatments are popular and used in wound treatment; however, there is presently little evidence of the effectiveness of silver-containing treatment for the prevention of obstetrical wound infection. We plan to investigate the rate of infection in women experiencing cesarean sections at Vanderbilt University Medical Center (VUMC) by comparing the infection rate based on a randomized choice of silver-containing wound dressings to soft cloth adhesive wound dressings.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

475

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Cesarean delivery with pfannenstiel incision

Exclusion Criteria:

  • Incision other than pfannenstiel
  • Silver allergy
  • Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Silver-containing surgical dressing
Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver
Device: Silver-containing surgical dressing
Dressing placed over surgical incision and remain for 3-5 days
Other Names:
  • Acticoat
Active Comparator: Cloth adhesive dressing
Soft cloth adhesive wound dressing
Device: Cloth adhesive dressing
Cloth adhesive dressing placed over surgical incision and remains for 3-5 days
Other Names:
  • Medipore

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Silver Treatment Efficacy
Time Frame: 6 weeks postpartum
As measured by number of patients with postop infections at 6 wks
6 weeks postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection Rate Adjusted for Maternal BMI
Time Frame: 6 weeks postpartum
6 weeks postpartum
Patient Dressing Cost
Time Frame: Postoperative
Total cost of dressings per group based on 1 dressing per patient
Postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: Kelly A. Bennett, MD, Vanderbilt University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

July 22, 2010

First Submitted That Met QC Criteria

July 22, 2010

First Posted (Estimate)

July 23, 2010

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VUMFM-100785

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Wound Infection

Clinical Trials on Silver-containing surgical dressing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe