Surgical Site Infection in Obese Women Undergoing C-section Clinical Trial
Official title:
Use of 48 Hour Course of Antibiotics to Prevent Surgical Site Infection in Obese Patients Undergoing Cesarean Delivery
The purpose of this study is to evaluate if preoperative antibiotics, followed by 48 hour course of broad spectrum antibiotics prevents wound infection complications in patients that are obese who undergo cesarean section. Standard antibiotic prophylaxis in all weight women undergoing cesarean section is cefazolin prior to skin incision. It is the hypothesis that a prolonged, 48 hour course of broad spectrum antibiotics that are suited to prevent growth of normal vaginal flora will decrease the rate of surgical site infection in obese patients that are at a greatly increased risk of postoperative infections complications.
We propose the conduction of a prospective, randomized, double-blinded clinical trial to
evaluate an alternative prophylactic regimen for the prevention of surgical site infection.
This study is to be conducted by the Department of Obstetrics at University Hospital. The
intervention being studied will be the continuation of cephalexin and metronidazole for 48
hours. The primary outcome measure will be the development of infectious morbidity,
including wound infection and endometritis, in the postoperative 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 filtration 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 antimicrobial, adhesive drape will be used.
Prior to skin incision, cefazolin will be administered.
All patients to be considered for recruitment to this study will be undergoing delivery at
University Hospital. Patients with an elevated BMI > 30 kg/m2 who undergo cesarean section
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention