Plasma and Tissue Concentration of Cefazolin in Preoperat... | NCT07253805

Plasma and Tissue Concentration of Cefazolin in Preoperat... | NCT07253805 | Trialant

Sponsor/Collaborators Module

Name	Class
Fondation IUCPQ	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under the Concentration-Time Curve (AUC) of Cefazolin in Plasma, Adipose Tissue, and Dermal Tissue	AUC of cefazolin will be measured in plasma, adipose tissue, and dermal tissue at 0 minutes, 30 minutes, and at the end of surgery following administration according to current dosing guidelines. Unit of Measure: mg·min/L	During surgery

Secondary Outcomes

Measure	Description	Time Frame
Proportion of Patients Achieving Cefazolin Tissue Concentrations ≥ 8 mg/L	Proportion of patients with adipose and dermal tissue concentrations of cefazolin ≥ 8 mg/L at any time point (0 min, 30 min, end of surgery), based on the MIC for Enterobacteriaceae. Unit of Measure: Percentage of patients (%)	During surgery

Other Outcomes

Measure	Description	Time Frame
Screening and Eligibility Verification Through Demographic and Clinical Data	Participants will be evaluated during preoperative consultation by a bariatric surgeon. If eligible, informed consent will be obtained. Demographic and clinical data will be collected to confirm inclusion criteria: Height (cm) Weight at recruitment (kg) BMI at recruitment (kg/m²) Allergy status to penicillin Blood samples will confirm: Absence of liver cirrhosis Absence of chronic kidney disease (eGFR < 60 mL/min based on Cockcroft-Gault equation)

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval		Québec	Quebec	G1V 4G5	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27272580	Result	Flegal KM, Kruszon-Moran D, Carroll MD, Fryar CD, Ogden CL. Trends in Obesity Among Adults in the United States, 2005 to 2014. JAMA. 2016 Jun 7;315(21):2284-91. doi: 10.1001/jama.2016.6458.
16466885	Result	Nicoli S, Santi P. Assay of amikacin in the skin by high-performance liquid chromatography. J Pharm Biomed Anal. 2006 Jun 7;41(3):994-7. doi: 10.1016/j.jpba.2005.12.029. Epub 2006 Feb 8.

Label	URL
WHO- Obesity and overweight- May, 7, 2025	View source

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Apr 8, 2019	Nov 19, 2025	Prot_SAP_000.pdf

23245609

Result

Lim SS, Vos T, Flaxman AD, Danaei G, Shibuya K, Adair-Rohani H, Amann M, Anderson HR, Andrews KG, Aryee M, Atkinson C, Bacchus LJ, Bahalim AN, Balakrishnan K, Balmes J, Barker-Collo S, Baxter A, Bell ML, Blore JD, Blyth F, Bonner C, Borges G, Bourne R, Boussinesq M, Brauer M, Brooks P, Bruce NG, Brunekreef B, Bryan-Hancock C, Bucello C, Buchbinder R, Bull F, Burnett RT, Byers TE, Calabria B, Carapetis J, Carnahan E, Chafe Z, Charlson F, Chen H, Chen JS, Cheng AT, Child JC, Cohen A, Colson KE, Cowie BC, Darby S, Darling S, Davis A, Degenhardt L, Dentener F, Des Jarlais DC, Devries K, Dherani M, Ding EL, Dorsey ER, Driscoll T, Edmond K, Ali SE, Engell RE, Erwin PJ, Fahimi S, Falder G, Farzadfar F, Ferrari A, Finucane MM, Flaxman S, Fowkes FG, Freedman G, Freeman MK, Gakidou E, Ghosh S, Giovannucci E, Gmel G, Graham K, Grainger R, Grant B, Gunnell D, Gutierrez HR, Hall W, Hoek HW, Hogan A, Hosgood HD 3rd, Hoy D, Hu H, Hubbell BJ, Hutchings SJ, Ibeanusi SE, Jacklyn GL, Jasrasaria R, Jonas JB, Kan H, Kanis JA, Kassebaum N, Kawakami N, Khang YH, Khatibzadeh S, Khoo JP, Kok C, Laden F, Lalloo R, Lan Q, Lathlean T, Leasher JL, Leigh J, Li Y, Lin JK, Lipshultz SE, London S, Lozano R, Lu Y, Mak J, Malekzadeh R, Mallinger L, Marcenes W, March L, Marks R, Martin R, McGale P, McGrath J, Mehta S, Mensah GA, Merriman TR, Micha R, Michaud C, Mishra V, Mohd Hanafiah K, Mokdad AA, Morawska L, Mozaffarian D, Murphy T, Naghavi M, Neal B, Nelson PK, Nolla JM, Norman R, Olives C, Omer SB, Orchard J, Osborne R, Ostro B, Page A, Pandey KD, Parry CD, Passmore E, Patra J, Pearce N, Pelizzari PM, Petzold M, Phillips MR, Pope D, Pope CA 3rd, Powles J, Rao M, Razavi H, Rehfuess EA, Rehm JT, Ritz B, Rivara FP, Roberts T, Robinson C, Rodriguez-Portales JA, Romieu I, Room R, Rosenfeld LC, Roy A, Rushton L, Salomon JA, Sampson U, Sanchez-Riera L, Sanman E, Sapkota A, Seedat S, Shi P, Shield K, Shivakoti R, Singh GM, Sleet DA, Smith E, Smith KR, Stapelberg NJ, Steenland K, Stockl H, Stovner LJ, Straif K, Straney L, Thurston GD, Tran JH, Van Dingenen R, van Donkelaar A, Veerman JL, Vijayakumar L, Weintraub R, Weissman MM, White RA, Whiteford H, Wiersma ST, Wilkinson JD, Williams HC, Williams W, Wilson N, Woolf AD, Yip P, Zielinski JM, Lopez AD, Murray CJ, Ezzati M, AlMazroa MA, Memish ZA. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2224-60. doi: 10.1016/S0140-6736(12)61766-8.