Prevention of Surgical Site Infection After Cesarean Delivery

• Status: Withdrawn
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

There are approximately 1.4 million cesarean deliveries in the United States each year, and an average of 1250 elective cesarean deliveries each year at the Brigham and Women's Hospital (BWH) in Boston, Massachusetts. Among cesarean deliveries performed at BWH, approximately 2% of patients are diagnosed with a surgical site infection (SSI). Because SSI is associated with significant morbidity and increased cost of care, numerous guidelines exist to guide preoperative administration of prophylactic antibiotics. However, there are no recommendations for the choice of antiseptic solution for prevention of SSI. Among the currently popular antisepsis preparations, chlorhexidine-alcohol (CA) is known to decrease SSI in non-obstetric surgeries. However, the time required for CA to dry (~ 3 min) to minimize flammability risk is disadvantageous in the setting of emergent cesarean delivery. Many institutions use povidone-iodine, another antisepsis preparation that does not require the mandatory drying time. Our randomized study aims to compare the incidence of SSI in patients receiving either CA or PI during elective cesarean delivery, and we hypothesize that CA would be associated with a lower incidence of SSI.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Cadexomer iodine; Chlorhexidine; Chlorhexidine gluconate; Ethanol; Iodine; Povidone; Povidone-Iodine

Criteria

Inclusion Criteria:

• All patients scheduled for elective cesarean delivery

Exclusion Criteria:

• Allergy to either of the antiseptic preparations

• Ongoing active skin or systemic infection

• Pre-operative antibiotic therapy for non-surgical reasons

• Those unable to receive antibiotic prophylaxis