Plasma and Tissue Concentration of Cefazolin in Preoperative Prophylaxis in Patients Undergoing Bariatric Surgery
NCT ID: NCT07253805
Last Updated: 2025-11-28
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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ACTIVE_NOT_RECRUITING
70 participants
OBSERVATIONAL
2019-04-11
2026-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Clindamycin group/control
A control group of 10 patients undergoing sleeve gastrectomy at the Quebec Heart and Lung Institute, who have not been exposed to cefazolin due to penicillin allergy, will be recruited to validate the analytical method. During surgery, biopsies of adipose and dermal tissue and blood samples will be collected. No other antibiotic or medications will be administered to these patients.
No interventions assigned to this group
Ancef group
Sixty patients will be recruited for the study, with 20 patients assigned to each weight category. Recruitment will take place during the preoperative consultation at the bariatric surgery clinic. All patients expressing interest will be included, provided they do not meet any exclusion criteria (convenience sampling). During surgery, biopsies of adipose and dermal tissue and blood samples, will be collected. No additional antibiotics or medications will be administered to these patients.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Undergo bariatric surgery (sleeve gastrectomy) via laparoscopy
Exclusion Criteria
* Weight over 180 kg
* Penicillin allergy
* Pregnant or breastfeeding women
* Chronic kidney disease (eGFR \< 60 ml/min according to the Cockcroft-Gault equation)
* Liver cirrhosis
* Intraoperative blood loss ≥ 1 liter
18 Years
ALL
No
Sponsors
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Fondation IUCPQ
OTHER
Laval University
OTHER
Responsible Party
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François Julien
General and Bariatric Surgeon, and Clinical Researcher, MD.
Locations
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Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec, Canada
Countries
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References
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Unger NR, Stein BJ. Effectiveness of pre-operative cefazolin in obese patients. Surg Infect (Larchmt). 2014 Aug;15(4):412-6. doi: 10.1089/sur.2012.167. Epub 2014 May 13.
Pories WJ, van Rij AM, Burlingham BT, Fulghum RS, Meelheim D. Prophylactic cefazolin in gastric bypass surgery. Surgery. 1981 Aug;90(2):426-32.
Hites M, Deprez G, Wolff F, Ickx B, Verleije A, Closset J, Loi P, Prevost J, Taccone FS, Racape J, Cotton F, Jacobs F. Evaluation of total body weight and body mass index cut-offs for increased cefazolin dose for surgical prophylaxis. Int J Antimicrob Agents. 2016 Dec;48(6):633-640. doi: 10.1016/j.ijantimicag.2016.08.019. Epub 2016 Oct 5.
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Chen X, Brathwaite CE, Barkan A, Hall K, Chu G, Cherasard P, Wang S, Nicolau DP, Islam S, Cunha BA. Optimal Cefazolin Prophylactic Dosing for Bariatric Surgery: No Need for Higher Doses or Intraoperative Redosing. Obes Surg. 2017 Mar;27(3):626-629. doi: 10.1007/s11695-016-2331-9.
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Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA; American Society of Health-System Pharmacists; Infectious Disease Society of America; Surgical Infection Society; Society for Healthcare Epidemiology of America. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm. 2013 Feb 1;70(3):195-283. doi: 10.2146/ajhp120568. No abstract available.
Shabanzadeh DM, Sorensen LT. Laparoscopic surgery compared with open surgery decreases surgical site infection in obese patients: a systematic review and meta-analysis. Ann Surg. 2012 Dec;256(6):934-45. doi: 10.1097/SLA.0b013e318269a46b.
Peppard WJ, Eberle DG, Kugler NW, Mabrey DM, Weigelt JA. Association between Pre-Operative Cefazolin Dose and Surgical Site Infection in Obese Patients. Surg Infect (Larchmt). 2017 May/Jun;18(4):485-490. doi: 10.1089/sur.2016.182. Epub 2016 Dec 1.
Chopra T, Zhao JJ, Alangaden G, Wood MH, Kaye KS. Preventing surgical site infections after bariatric surgery: value of perioperative antibiotic regimens. Expert Rev Pharmacoecon Outcomes Res. 2010 Jun;10(3):317-28. doi: 10.1586/erp.10.26.
Freeman JT, Anderson DJ, Hartwig MG, Sexton DJ. Surgical site infections following bariatric surgery in community hospitals: a weighty concern? Obes Surg. 2011 Jul;21(7):836-40. doi: 10.1007/s11695-010-0105-3.
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Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2011. Obes Surg. 2013 Apr;23(4):427-36. doi: 10.1007/s11695-012-0864-0.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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WHO- Obesity and overweight- May, 7, 2025
Other Identifiers
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CER 21626, 2019-3053
Identifier Type: -
Identifier Source: org_study_id
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