Back to resultsTopical Silver for Prevention of Wound Infection After Cesarean Delivery
Primary Purpose
Wound Infection
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Silver-containing surgical dressing
Cloth adhesive dressing
Sponsored by
About this trial
This is an interventional prevention trial for Wound Infection focused on measuring Wound infection prevention, Silver-containing surgical dressing, Cesarean delivery infection prevention
Eligibility Criteria
Inclusion Criteria:
- Cesarean delivery with pfannenstiel incision
Exclusion Criteria:
- Incision other than pfannenstiel
- Silver allergy
- Inability to provide informed consent
Sites / Locations
- Vanderbilt University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Silver-containing surgical dressing
Cloth adhesive dressing
Arm Description
Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver
Soft cloth adhesive wound dressing
Outcomes
Primary Outcome Measures
Silver Treatment Efficacy
As measured by number of patients with postop infections at 6 wks
Secondary Outcome Measures
Infection Rate Adjusted for Maternal BMI
Patient Dressing Cost
Total cost of dressings per group based on 1 dressing per patient
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01169064
Brief Title
Topical Silver for Prevention of Wound Infection After Cesarean Delivery
Official Title
Topical Silver for Prevention of Wound Infection Post Cesarean Delivery: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis showed no statistical significance achieved.
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection
Keywords
Wound infection prevention, Silver-containing surgical dressing, Cesarean delivery infection prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
475 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Silver-containing surgical dressing
Arm Type
Active Comparator
Arm Description
Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver
Arm Title
Cloth adhesive dressing
Arm Type
Active Comparator
Arm Description
Soft cloth adhesive wound dressing
Intervention Type
Device
Intervention Name(s)
Silver-containing surgical dressing
Other Intervention Name(s)
Acticoat
Intervention Description
Dressing placed over surgical incision and remain for 3-5 days
Intervention Type
Device
Intervention Name(s)
Cloth adhesive dressing
Other Intervention Name(s)
Medipore
Intervention Description
Cloth adhesive dressing placed over surgical incision and remains for 3-5 days
Primary Outcome Measure Information:
Title
Silver Treatment Efficacy
Description
As measured by number of patients with postop infections at 6 wks
Time Frame
6 weeks postpartum
Secondary Outcome Measure Information:
Title
Infection Rate Adjusted for Maternal BMI
Time Frame
6 weeks postpartum
Title
Patient Dressing Cost
Description
Total cost of dressings per group based on 1 dressing per patient
Time Frame
Postoperative
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cesarean delivery with pfannenstiel incision
Exclusion Criteria:
Incision other than pfannenstiel
Silver allergy
Inability to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly A. Bennett, MD
Organizational Affiliation
Vanderbilt University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
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Topical Silver for Prevention of Wound Infection After Cesarean Delivery
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