Prophylactic Antibiotics After Cesarean
Condition: Surgical Site Infection
MeSH terms: Surgical Wound Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if the addition of a 48-hour course of
      post-operative antibiotics to the recommended course of pre-operative antibiotics improves
      surgical site infection rate in patients who are obese and undergo Cesarean section after
      laboring.
    

Detailed description: 
      The investigators propose the conduction of a prospective, randomized, double-blinded
      clinical trial to evaluate an alternative prophylactic regimen for the prevention of surgical
      site infection in women who are obese and have been laboring prior to their Cesarean section.
      This study is to be conducted by the Department of Obstetrics & Gynecology at John Sealy
      Hospital at the University of Texas Medical Branch in Galveston, Texas. The intervention
      being studied will be the administration of cephalexin and metronidazole post-operatively for
      48 hours. The primary outcome measure will be surgical site infection (including superficial
      or deep incisional surgical site infection, endometritis, and other related infections, such
      as septic pelvic thrombophlebitis and abdominal or pelvic abscess) in the post-operative
      period.

      In order to most effectively and accurately analyze our primary and secondary research
      outcomes, the investigators will standardize our surgical operation techniques in all ways
      feasible. These recommendations will be in concordance with American College of Obstetrics
      and Gynecology recommendations, as those generally accepted in the medical literature. All
      patients will undergo surgery in the same small group of HEPA-filtered and positive
      air-pressure operating rooms. Appropriate limitations on number of surgeons and assistants
      scrubbed for surgery, as well as general OR traffic, will be enforced. Patients will undergo
      hair clipping of the incision site when appropriate. Chlorhexidine skin decontamination will
      be the standard surgical site preparation. An adhesive drape will be used. Prior to skin
      incision, cefazolin and azithromycin will be administered.

      All patients to be considered for recruitment to this study will be undergoing delivery at
      John Sealy Hospital at the University of Texas Medical Branch in Galveston, Texas. Patients
      with an elevated BMI >or =30 kg/m2 who undergo cesarean section after laboring will be
      considered for randomization either prior to delivery or in the first 7 hours after delivery,
      to accommodate the need for the first dose of study medication or placebo 8 hours after
      surgery. Only patients who agree to inclusion after informed consent will be randomized per
      protocol.
    

Intervention name(s): Cephalexin; Placebo; Metronidazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Other name(s): Keflex (cephalexin) Cephalexin at 500 mg per oral every 8 hours for a total of 6 doses; Placebo representing standard of care; Other name(s): Flagyl (metronidazole) Metronidazole at 500 mg per oral every 8 hours for a total of 6 doses
Intervention MeSH terms: Metronidazole; Cephalexin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment