Topical Silver for Prevention of Wound Infection After Cesarean Delivery

Not Applicable

Terminated

• Conditions: Wound Infection
• Interventions: Device: Cloth adhesive dressing; Device: Silver-containing surgical dressing

• Registration Number: NCT01169064
• Lead Sponsor: Vanderbilt University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-22
• Study First Submitted QC: 2010-07-22
• Study First Posted: 2010-07-23
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2016-03-14
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-19
• Last Update Submitted: 2017-04-19
• Results First Posted: 2017-05-30
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 475

Inclusion Criteria

• Cesarean delivery with pfannenstiel incision

Exclusion Criteria

• Incision other than pfannenstiel
• Silver allergy
• Inability to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cloth adhesive dressing	Cloth adhesive dressing	Soft cloth adhesive wound dressing
Silver-containing surgical dressing	Silver-containing surgical dressing	Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver

Primary Outcome Measures

Name	Time	Method
Silver Treatment Efficacy	6 weeks postpartum	As measured by number of patients with postop infections at 6 wks

Secondary Outcome Measures

Name	Time	Method
Infection Rate Adjusted for Maternal BMI	6 weeks postpartum
Patient Dressing Cost	Postoperative	Total cost of dressings per group based on 1 dressing per patient

Trial Locations

Locations (1)

Vanderbilt University Hospital; 🇺🇸 Nashville, Tennessee, United States