Topical Silver for Prevention of Wound Infection After Cesarean Delivery

Vanderbilt University

Status: Terminated

Conditions: Wound Infection

Treatments: Device: Silver-containing surgical dressing; Device: Cloth adhesive dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT01169064

VUMFM-100785

Details and patient eligibility

About

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.

Enrollment: 475 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cesarean delivery with pfannenstiel incision

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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475 participants in 2 patient groups

Silver-containing surgical dressing

Active Comparator group

Description:

Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver

Treatment:

Device: Silver-containing surgical dressing

Cloth adhesive dressing

Active Comparator group

Description:

Soft cloth adhesive wound dressing

Treatment:

Device: Cloth adhesive dressing