Use of 48 Hour Course of Antibiotics to Prevent Surgical Site Infection in Obese Patients Undergoing Cesarean Delivery
NCT ID: NCT01194115
Last Updated: 2011-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
475 participants
INTERVENTIONAL
2010-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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
cephalexin & metronidazole
cephalexin at 500 mg per oral every 8 hours for a total of 6 doses
Placebo/standard of care
Placebo pills per oral every 8 hours for total of 6 doses
placebo
placebo representing standard of care
Interventions
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cephalexin & metronidazole
cephalexin at 500 mg per oral every 8 hours for a total of 6 doses
placebo
placebo representing standard of care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Delivery via cesarean section
* consent to participate
* age 13 or older
Exclusion Criteria
* non-English speaking
* known allergy to cephalosporins or metronidazole
13 Years
FEMALE
No
Sponsors
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University of Cincinnati
OTHER
Responsible Party
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Rose Maxwell, Ph.D.
Director of Clinical Research
Principal Investigators
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Carri Warshak, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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The Univeristy Hospital
Cincinnati, Ohio, United States
Countries
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References
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Hofmeyr GJ, Smaill FM. WITHDRAWAN. Antibiotic prophylaxis for cesarean section. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD000933. doi: 10.1002/14651858.CD000933.pub2.
Meyer NL, Hosier KV, Scott K, Lipscomb GH. Cefazolin versus cefazolin plus metronidazole for antibiotic prophylaxis at cesarean section. South Med J. 2003 Oct;96(10):992-5. doi: 10.1097/01.SMJ.0000060570.51934.14.
Robinson HE, O'Connell CM, Joseph KS, McLeod NL. Maternal outcomes in pregnancies complicated by obesity. Obstet Gynecol. 2005 Dec;106(6):1357-64. doi: 10.1097/01.AOG.0000188387.88032.41.
Elyan A, Mahran M, el-Maraghy M, Abou-Seeda M. Prophylactic intravenous metronidazole in cesarean section. Chemioterapia. 1984 Feb;3(1):67-70.
Tita AT, Owen J, Stamm AM, Grimes A, Hauth JC, Andrews WW. Impact of extended-spectrum antibiotic prophylaxis on incidence of postcesarean surgical wound infection. Am J Obstet Gynecol. 2008 Sep;199(3):303.e1-3. doi: 10.1016/j.ajog.2008.06.068.
Valent AM, DeArmond C, Houston JM, Reddy S, Masters HR, Gold A, Boldt M, DeFranco E, Evans AT, Warshak CR. Effect of Post-Cesarean Delivery Oral Cephalexin and Metronidazole on Surgical Site Infection Among Obese Women: A Randomized Clinical Trial. JAMA. 2017 Sep 19;318(11):1026-1034. doi: 10.1001/jama.2017.10567.
Other Identifiers
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Surgical Site Infection C-Sect
Identifier Type: -
Identifier Source: org_study_id