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NCT01169064 Clinical Trial

Topical Silver for Prevention of Wound Infection After Cesarean Delivery

Wound Infection Clinical Trial

Official title:
Topical Silver for Prevention of Wound Infection Post Cesarean Delivery: A Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01169064
Other study ID # VUMFM-100785
Secondary ID
Status Terminated
Phase N/A
First received July 22, 2010
Last updated February 5, 2013
Start date July 2010
Est. completion date July 2012

Study information
Verified date February 2013
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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 VUMC by comparing the infection rate based on a randomized choice of silver-containing wound dressings to soft cloth adhesive wound dressings.

Recruitment information / eligibility
Status Terminated
Enrollment 524
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Cesarean delivery with pfannenstiel incision

Exclusion Criteria:

- Incision other than pfannenstiel

- Silver allergy

- Inability to provide informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• Silver-containing surgical dressing
Dressing placed over surgical incision and remain for 3-5 days
• Cloth adhesive dressing
Dressing placed over surgical incision and remains for 3-5 days

Locations
Country Name City State
United States Vanderbilt University Hospital Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Silver treatment efficacy 6 weeks postpartum No
Secondary Infection/complication variables 6 weeks postpartum Yes
See also
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Completed NCT00576745 - A Comparison Of The 3M TM S Surgical Skin Closure System To The Standard Vicryl Suture Closure of Sternotomy Incisions During Cardiac Surgery Phase 1
Terminated NCT00654641 - Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy N/A
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Active, not recruiting NCT04584957 - Prophylactic Negative Pressure Wound Therapy (VAC) in Gynecologic Oncology (G.O.) N/A
Recruiting NCT03960970 - Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries Phase 2
Enrolling by invitation NCT03880188 - Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Completed NCT02018094 - The Amputation Surgical Site Infection Trial (ASSIT) Phase 4
Terminated NCT03269968 - Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery N/A
Enrolling by invitation NCT02945761 - High Concentration of Sugar Solution Irrigation Promotes the Healing of Infected Wound N/A
Not yet recruiting NCT02882360 - Kerlix for Pregnant Women With Elevated BMI to Prevent Wound Infection by 6 Weeks Post Partum Phase 4