Continuous v Bolus Infusion of Cefazolin During Ventral Hernia Repair
NCT ID: NCT02666365
Last Updated: 2018-05-24
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE4
INTERVENTIONAL
2018-03-31
2019-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Insitu Repair Versus Uterine Exeriorization During Cesarean Section
NCT01723605
Risk Factors for Development of Incisional Hernia in Transverse Incisions
NCT03561727
Clinical Evaluation of Cohera Sylys Surgical Sealant as an Adjunct to Standard Bowel Anastomosis Closure
NCT02196519
Prevention of Postoperative Ventral Hernias
NCT04562363
Surgery with Botulinum Toxin a for Incisional Hernia
NCT06499324
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bolus infusion of Cefazolin
Subjects undergoing a ventral hernia repair in this arm of the study will receive the surgical prophylactic, cefazolin, in a bolus infusion
Bolus infusion of Cefazolin
Subjects in the bolus infusion arm of the study will receive bolus infusions of cefazolin throughout the surgical procedure
Continuous Infusion of Cefazolin
Subjects undergoing a ventral hernia repair in this arm of the study will receive the surgical prophylactic, cefazolin, in a continuous infusion
Continuous infusion of Cefazolin
Subjects in the continuous infusion arm of the study will receive a continuous infusion of the cefazolin throughout the surgical procedure
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bolus infusion of Cefazolin
Subjects in the bolus infusion arm of the study will receive bolus infusions of cefazolin throughout the surgical procedure
Continuous infusion of Cefazolin
Subjects in the continuous infusion arm of the study will receive a continuous infusion of the cefazolin throughout the surgical procedure
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Elective open Ventral hernia repair in CDC class one (clean) cases
* Planned operative time greater than 4 Hours
* Planned routine administration of cefazolin for pre-op prophylaxis
* No history of MRSA
Exclusion Criteria
* Allergy to cephalosporins
* Pre-existing documented infection or ostomy (class II-IV wounds)
* Received cefazolin within 24 hours before surgery
* Creatinine clearance \< 30 ml/min
* Upstaging of wound class intra-op that results in the administration of additional antibiotics
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Milton S. Hershey Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kunal Karamchandani
Assistant Professor of Anesthesiology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kunal Karamchandani, MD
Role: PRINCIPAL_INVESTIGATOR
Milton S. Hershey Medical Center
References
Explore related publications, articles, or registry entries linked to this study.
MILES AA, MILES EM, BURKE J. The value and duration of defence reactions of the skin to the primary lodgement of bacteria. Br J Exp Pathol. 1957 Feb;38(1):79-96. No abstract available.
Lee FM, Trevino S, Kent-Street E, Sreeramoju P. Antimicrobial prophylaxis may not be the answer: Surgical site infections among patients receiving care per recommended guidelines. Am J Infect Control. 2013 Sep;41(9):799-802. doi: 10.1016/j.ajic.2012.11.021. Epub 2013 Mar 13.
Hawn MT, Vick CC, Richman J, Holman W, Deierhoi RJ, Graham LA, Henderson WG, Itani KM. Surgical site infection prevention: time to move beyond the surgical care improvement program. Ann Surg. 2011 Sep;254(3):494-9; discussion 499-501. doi: 10.1097/SLA.0b013e31822c6929.
Stulberg JJ, Delaney CP, Neuhauser DV, Aron DC, Fu P, Koroukian SM. Adherence to surgical care improvement project measures and the association with postoperative infections. JAMA. 2010 Jun 23;303(24):2479-85. doi: 10.1001/jama.2010.841.
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 (ASHP); Infectious Diseases Society of America (IDSA); Surgical Infection Society (SIS); Society for Healthcare Epidemiology of America (SHEA). Clinical practice guidelines for antimicrobial prophylaxis in surgery. Surg Infect (Larchmt). 2013 Feb;14(1):73-156. doi: 10.1089/sur.2013.9999. Epub 2013 Mar 5. No abstract available.
Adembri C, Ristori R, Chelazzi C, Arrigucci S, Cassetta MI, De Gaudio AR, Novelli A. Cefazolin bolus and continuous administration for elective cardiac surgery: improved pharmacokinetic and pharmacodynamic parameters. J Thorac Cardiovasc Surg. 2010 Aug;140(2):471-5. doi: 10.1016/j.jtcvs.2010.03.038. Epub 2010 Jun 8.
Trent Magruder J, Grimm JC, Dungan SP, Shah AS, Crow JR, Shoulders BR, Lester L, Barodka V. Continuous Intraoperative Cefazolin Infusion May Reduce Surgical Site Infections During Cardiac Surgical Procedures: A Propensity-Matched Analysis. J Cardiothorac Vasc Anesth. 2015 Dec;29(6):1582-7. doi: 10.1053/j.jvca.2015.03.026. Epub 2015 Mar 31.
Ferraz AA, Siqueira LT, Campos JM, Araujo GC, Martins Filho ED, Ferraz EM. ANTIBIOTIC PROPHYLAXIS IN BARIATRIC SURGERY: a continuous infusion of cefazolin versus ampicillin/sulbactam and ertapenem. Arq Gastroenterol. 2015 Apr-Jun;52(2):83-7. doi: 10.1590/S0004-28032015000200002.
Finan KR, Vick CC, Kiefe CI, Neumayer L, Hawn MT. Predictors of wound infection in ventral hernia repair. Am J Surg. 2005 Nov;190(5):676-81. doi: 10.1016/j.amjsurg.2005.06.041.
Dunne JR, Malone DL, Tracy JK, Napolitano LM. Abdominal wall hernias: risk factors for infection and resource utilization. J Surg Res. 2003 May 1;111(1):78-84. doi: 10.1016/s0022-4804(03)00077-5.
Houck JP, Rypins EB, Sarfeh IJ, Juler GL, Shimoda KJ. Repair of incisional hernia. Surg Gynecol Obstet. 1989 Nov;169(5):397-9.
Kaafarani HM, Kaufman D, Reda D, Itani KM. Predictors of surgical site infection in laparoscopic and open ventral incisional herniorrhaphy. J Surg Res. 2010 Oct;163(2):229-34. doi: 10.1016/j.jss.2010.03.019. Epub 2010 Apr 1.
Blatnik JA, Krpata DM, Novitsky YW, Rosen MJ. Does a history of wound infection predict postoperative surgical site infection after ventral hernia repair? Am J Surg. 2012 Mar;203(3):370-4; discussion 374. doi: 10.1016/j.amjsurg.2011.12.001.
Buijk SE, Gyssens IC, Mouton JW, Metselaar HJ, Groenland TH, Verbrugh HA, Bruining HA. Perioperative pharmacokinetics of cefotaxime in serum and bile during continuous and intermittent infusion in liver transplant patients. J Antimicrob Chemother. 2004 Jul;54(1):199-205. doi: 10.1093/jac/dkh268. Epub 2004 Jun 2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY00003845
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.