Study Stopped
Interim analysis showed no statistical significance achieved.
Topical Silver for Prevention of Wound Infection After Cesarean Delivery
1 other identifier
interventional
475
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 22, 2010
CompletedFirst Posted
Study publicly available on registry
July 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
May 30, 2017
CompletedMay 30, 2017
April 1, 2017
2 years
July 22, 2010
March 14, 2016
April 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Silver Treatment Efficacy
As measured by number of patients with postop infections at 6 wks
6 weeks postpartum
Secondary Outcomes (2)
Infection Rate Adjusted for Maternal BMI
6 weeks postpartum
Patient Dressing Cost
Postoperative
Study Arms (2)
Silver-containing surgical dressing
ACTIVE COMPARATORSelf adhesive 4 x 10 dressing impregnated with nanocrystalline silver
Cloth adhesive dressing
ACTIVE COMPARATORSoft cloth adhesive wound dressing
Interventions
Dressing placed over surgical incision and remain for 3-5 days
Cloth adhesive dressing placed over surgical incision and remains for 3-5 days
Eligibility Criteria
You may qualify if:
- Cesarean delivery with pfannenstiel incision
You may not qualify if:
- Incision other than pfannenstiel
- Silver allergy
- Inability to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Hospital
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Kelly Bennett; Director of Maternal Fetal Medicine
- Organization
- Vanderbilt University Medical Ctr., Dept OB/GYN
Study Officials
- PRINCIPAL INVESTIGATOR
Kelly A. Bennett, MD
Vanderbilt University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 22, 2010
First Posted
July 23, 2010
Study Start
July 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
May 30, 2017
Results First Posted
May 30, 2017
Record last verified: 2017-04