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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.)
Information provided by (Responsible Party):
Kelly Bennett, Vanderbilt University Identifier:
First received: July 22, 2010
Last updated: April 19, 2017
Last verified: April 2017
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: No masking
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


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

Inclusion Criteria:

  • Cesarean delivery with pfannenstiel incision

Exclusion Criteria:

  • Incision other than pfannenstiel
  • Silver allergy
  • Inability to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01169064

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

Responsible Party: Kelly Bennett, Associate Professor, Vanderbilt University Identifier: NCT01169064     History of Changes
Other Study ID Numbers: VUMFM-100785
Study First Received: July 22, 2010
Results First Received: March 14, 2016
Last Updated: April 19, 2017

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

Additional relevant MeSH terms:
Communicable Diseases
Wounds and Injuries
Wound Infection processed this record on June 23, 2017