Topical Silver for Prevention of Wound Infection After Cesarean Delivery

This study has been terminated.
(Interim analysis showed no statistical significance achieved.)
Sponsor:
Information provided by (Responsible Party):
Kelly Bennett, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01169064
First received: July 22, 2010
Last updated: February 5, 2013
Last verified: February 2013
  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 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Vanderbilt University:

Primary Outcome Measures:
  • Silver treatment efficacy [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Infection/complication variables [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: Yes ]

Enrollment: 524
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 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 wound dressing
Soft cloth adhesive wound dressing
Device: Cloth adhesive dressing
Dressing placed over surgical incision and remains for 3-5 days
Other Name: Medipore

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kelly Bennett, Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01169064     History of Changes
Other Study ID Numbers: VUMFM-100785
Study First Received: July 22, 2010
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 29, 2014