Chlorhexidine-Alcohol Versus Povidone-Iodine for Cesarean Antisepsis
Condition: Surgical Site Infection
MeSH terms: Surgical Wound Infection
Study type: Interventional

Summary: 
      Primary Hypothesis: chlorhexidine gluconate alcohol skin antiseptic preparation is superior
      to povidone-iodine scrub and paint skin antiseptic preparation for prevention of cesarean
      related surgical site infection.
    

Detailed description: 
      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 RedCAP 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).
    

Intervention name(s): Chlorhexidine - Isopropyl alcohol; Povidone-Iodine Scrub and Paint
Intervention type(s): Drug; Drug
Intervention description(s): Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA; Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA
Other intervention name(s): Chlora-Prep; Betadine
Intervention MeSH terms: Chlorhexidine; Povidone-Iodine; Povidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Surgical site infection; Surgical site antisepsis; Cesarean Delivery