Chlorhexidine-Alcohol Versus Povidone-Iodine for Cesarean Antisepsis

Patients who are considered likely to need cesarean delivery or who are planning cesarean
will be recruited and consented for study participation during prenatal care and/or at time
of admission to labor and delivery.

Patients undergoing cesarean who meet inclusion/exclusion criteria will be randomized to one
of two surgical preparations as listed above (1. Chlorhexidine Gluconate (CHG)-alcohol, or
2. Povidone Iodine (P-I) scrub and paint. Randomization will be performed by the consenting
surgeon (listed as key personnel) after the patient has arrived into the operating room for
cesarean. Pre-operative surgical site antisepsis will be performed according to
randomization. All other surgical practices will remain at the surgeon's discretion
according to standard of care at Metrohealth.

Patients will be examined daily by the obstetric team and evaluated for signs and symptoms
of surgical site infection, as standard in the investigators institution. The chart will be
reviewed to determine if the patient was diagnosed during admission, or, re-admitted because
of surgical site infection. The patient will also be questioned regarding any treatment or
diagnosis of Surgical Site Infection (SSI) that occured after discharge to home at the
routine six week post-operative visit. If patient does not return for the routine
post-operative visit, the investigator will attempt to contact the patient by telephone to
determine if the patient had been diagnosed or treated for surgical site infection. If
patient is lost to 6 week follow up, subanalysis will be performed on available data derived
from hospitalization and hospital Electronic Medical Record (EMR).

Data will be captured in Red CAP database.

Additional data will be captured that may affect patient likelihood of surgical site
infection to ensure that both groups are statistically equal in risk factors for SSI: labor
or rupture of membranes prior to cesarean, maternal age, estimated gestational age, Body
Mass Index (BMI), gravity, parity, race, smoking status, hypertensive morbidity, diabetes,
estimated blood loss, operative time, race, insurance type, general versus regional
anesthesia, appropriate antibiotic prophylaxis given, skin closure (sutures v. staples).

Power analysis was performed: assuming 7.5% risk of cesarean site infection and a 50%
reduction with chlorhexidine, 932 individuals will be recruited. Approximately 800 cesareans
are performed at the investigators institution per year and the investigators anticipate
that 80% will be eligible to participate.

Data review will be done every 6 months or every 200 patients and analyzed, whichever is
sooner. Analysis will be performed by the Primary Investigators (PI) for completeness,
accuracy, strict adherence to study protocol, safety, and statistical significance. The
investigators site is also subject to periodic audits by the investigators Institutional
Review Board (IRB).

Inclusion Criteria:

- cesarean delivery

- age 18-65

- ability to consent in English or Spanish

Exclusion Criteria:

- inability or unwillingness to consent to study participation in English or Spanish

- current incarceration

- pre-operative diagnosis of chorioamnionitis

- perceived inability to complete follow up for data collection

- any prior known allergy or adverse reaction to either study preparation