Comparison of Surgical Skin Preps During Cesarean Deliveries
Condition: Surgical Site Infection Following Cesarean Delivery
MeSH terms: Surgical Wound Infection
Study type: Interventional

Summary: 
      In women that undergo non-emergency cesarean delivery, we are comparing the skin preparation
      solutions for best outcome of surgical site infection. The three different solutions are:
      Group 1: Iodine povidone based skin preparation solution. Group 2: Chlorhexidine based skin
      preparation solution or Group 3: Combination usage of iodine povidone and chlorhexidine based
      skin preparation solutions. Women are prospectively randomized to one of the three groups and
      followed until thier postpartum visit at 6-8 weeks following delivery.
    

Detailed description: 
      Currently the skin preparation solutions currently in use for cesarean delivery are
      chlorhexidine-alcohol based solutions or iodine povidone solutions There had been no
      recommendations of which surgical skin prep wound be best utilized for cesarean delivery,
      especially if the patient has risk factors for surgical site infection. Chlorhexidine
      solution has been reported to take minimal of 2 minutes after application to decrease the
      bacterial load, and continue to decrease the bacteria load up to 1 hour. Iodine povidone
      solution has been reported to be completely effective within 4 minutes of application.
      Patient's risk factor for surgical site infection, including obesity, history of incision
      complications, maternal diabetes, chorioamnionitis, potentially influence which surgical skin
      prep to be applied. Finally, the majority of postpartum infections manifest after hospital
      discharge and most of these post-discharge infections are diagnosed and treated entirely in
      the ambulatory setting, without the patients' returning to the hospital.

      The purpose of the study is:

        1. To compare chlorhexidine based solution, iodine povidone solution, and combination of
           both agents in cesarean delivery skin preparation solution for prevention of surgical
           site infection (SSI)

        2. To determine if surgical site infection (SSI) risk factors should guide selection of one
           specific surgical skin preparation solution.

      This will be a prospective randomized observational study of the women presenting for care to
      the Montefiore Medical Center. All patients will undergo routine obstetrical care and
      preparation for cesarean delivery as if they were not participating in this research study.
      All patients in the study will receive the pre-operative intravenous antibiotics
      pre-operatively as part of departmental protocol for cesarean delivery.

      The patients will be randomized after informed consent obtained into one of three groups:
      Group 1: Iodine povidone based skin preparation solution. Group 2: Chlorhexidine based skin
      preparation solution or Group 3: Combination usage of iodine povidone and chlorhexidine based
      skin preparation solutions. Sequentially numbered envelopes will contain the group of
      randomization for the patient created by a computer generated program which will occur prior
      to commencement of the study.

      Surgical preparation will follow the departmental protocol as if the patient were not in the
      study with exception of the skin preparation. Once the patient is randomized to the skin
      preparation group, the corresponding skin preparation solution will be used in accordance to
      manufacturer's guidelines for the product and Departmental protocol. If randomized to group 3
      (combination), the iodine based preparation will occur first followed by the chlorhexidine
      based skin preparation. All groups will wait a minimal of 4 minutes prior to skin incision
      after application of skin prep, and all patients will be surgically draped with the standard
      drapes as if not participating in a study. Cesarean delivery will occur following the
      technique of the surgeon, including skin closure method, suture or staples.

      All patients will be followed until the routine postpartum visit occurs at 6-8 weeks
      following delivery. Postpartum visit information will be extracted from the medical record.
      If no postpartum visit occurs, the patient will be contacted by telephone at 8 weeks post
      delivery and asked about any incisional complications which may have occurred and required
      treatment by as physician or healthcare provider in the office or hospital.
    

Intervention name(s): Iodine povidone; Chlorhexidine; Combination iodine and chlorhexidine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Iodine skin preparation solution prior to cesarean delivery; Chlorhexidine skin preparation solution prior to cesarean delivery; Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery
Intervention MeSH terms: Iodine; Chlorhexidine; Chlorhexidine gluconate; Cadexomer iodine; Povidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cesarean delivery; Surgical site infection; Pregnancy; Postpartum