Use of 48 Hour Course of Antibiotics to Prevent Surgical Site Infection in Obese Patients Undergoing Cesarean Delivery (SSI)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Rose Maxwell, Ph.D., University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01194115
First received: September 1, 2010
Last updated: November 10, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Surgical Site Infection in Obese Women Undergoing C-section
Drug: cephalexin & metronidazole
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Use of 48 Hour Course of Antibiotics to Prevent Surgical Site Infection in Obese Patients Undergoing Cesarean Delivery

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Surgical site infection [ Time Frame: 6weeks post partum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Febrile morbidity; Urinary tract infection; Endometritis [ Time Frame: 6 weeks post partum ] [ Designated as safety issue: No ]

Estimated Enrollment: 475
Study Start Date: September 2010
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cephalexin and metronidazole
500 mg cephalexin per oral every 8 hours for total of 6 doses; 500 mg metronidazole per oral every 8 hours for total of 6 doses
Drug: cephalexin & metronidazole
cephalexin at 500 mg per oral every 8 hours for a total of 6 doses
Other Name: Keflex & Flagyl
Placebo Comparator: Placebo/standard of care
Placebo pills per oral every 8 hours for total of 6 doses
Drug: placebo
placebo representing standard of care

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI > 30kg/m*2
  • Delivery via cesarean section
  • consent to participate
  • age 13 or older

Exclusion Criteria:

  • known immunodeficiency syndromes
  • non-English speaking
  • known allergy to cephalosporins or metronidazole
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194115

Locations
United States, Ohio
The Univeristy Hospital
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Carri Warshak, MD University of Cincinnati
  More Information

Publications:
Responsible Party: Rose Maxwell, Ph.D., Director of Clinical Research, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01194115     History of Changes
Other Study ID Numbers: Surgical Site Infection C-Sect
Study First Received: September 1, 2010
Last Updated: November 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
surgical site infection
obesity
pregnancy
cesarean section
cesarean delivery

Additional relevant MeSH terms:
Infection
Communicable Diseases
Metronidazole
Cephalexin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on September 18, 2014