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Topical Silver for Prevention of Wound Infection After Cesarean Delivery

This study has been terminated.
(Interim analysis showed no statistical significance achieved.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01169064
First Posted: July 23, 2010
Last Update Posted: May 30, 2017
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Kelly Bennett, Vanderbilt University
  Purpose
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.

Condition Intervention
Wound Infection Device: Silver-containing surgical dressing Device: Cloth adhesive dressing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Topical Silver for Prevention of Wound Infection Post Cesarean Delivery: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Kelly Bennett, Vanderbilt University:

Primary Outcome Measures:
  • Silver Treatment Efficacy [ Time Frame: 6 weeks postpartum ]
    As measured by number of patients with postop infections at 6 wks


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


Enrollment: 475
Study Start Date: July 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Medipore

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cesarean delivery with pfannenstiel incision

Exclusion Criteria:

  • Incision other than pfannenstiel
  • Silver allergy
  • Inability to provide informed consent
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01169064


Locations
United States, Tennessee
Vanderbilt University Hospital
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Kelly A. Bennett, MD Vanderbilt University School of Medicine
  More Information

Responsible Party: Kelly Bennett, Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01169064     History of Changes
Other Study ID Numbers: VUMFM-100785
First Submitted: July 22, 2010
First Posted: July 23, 2010
Results First Submitted: March 14, 2016
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017
Last Verified: April 2017

Keywords provided by Kelly Bennett, Vanderbilt University:
Wound infection prevention
Silver-containing surgical dressing
Cesarean delivery infection prevention

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wounds and Injuries
Wound Infection