Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01194115
Recruitment Status : Unknown
Verified November 2011 by Rose Maxwell, Ph.D., University of Cincinnati.
Recruitment status was:  Enrolling by invitation
First Posted : September 2, 2010
Last Update Posted : November 11, 2011
Sponsor:
Information provided by (Responsible Party):
Rose Maxwell, Ph.D., University of Cincinnati

Brief Summary:
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 or disease Intervention/treatment Phase
Surgical Site Infection in Obese Women Undergoing C-section Drug: cephalexin & metronidazole Drug: placebo Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 475 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2010
Estimated Primary Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Surgical site infection [ Time Frame: 6weeks post partum ]

Secondary Outcome Measures :
  1. Febrile morbidity; Urinary tract infection; Endometritis [ Time Frame: 6 weeks post partum ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01194115


Locations
Layout table for location information
United States, Ohio
The Univeristy Hospital
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati
Investigators
Layout table for investigator information
Principal Investigator: Carri Warshak, MD University of Cincinnati
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Rose Maxwell, Ph.D., Director of Clinical Research, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01194115    
Other Study ID Numbers: Surgical Site Infection C-Sect
First Posted: September 2, 2010    Key Record Dates
Last Update Posted: November 11, 2011
Last Verified: November 2011
Keywords provided by Rose Maxwell, Ph.D., University of Cincinnati:
surgical site infection
obesity
pregnancy
cesarean section
cesarean delivery
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Communicable Diseases
Surgical Wound Infection
Disease Attributes
Pathologic Processes
Wound Infection
Postoperative Complications
Metronidazole
Cephalexin
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents