NCT02666365

Brief Summary

Patients undergoing an elective ventral hernia repair will be randomly assigned to receive either bolus infusion or continuous infusion of the cefazolin as the prophylactic antibiotic. The blood concentrations of unbound cefazolin would be measured in their blood samples and the levels compared within the two groups with respect to their minimal inhibitory concentration (MIC) value.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2018

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
2.1 years until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

May 24, 2018

Status Verified

May 1, 2018

Enrollment Period

1 year

First QC Date

January 25, 2016

Last Update Submit

May 22, 2018

Conditions

Surgical Site Infections

Keywords

anesthesiasurgical antimicrobial prophylaxissurgical site infections

Outcome Measures

Primary Outcomes (1)

  • Difference in Area Under Curve (AUC) of Cefazolin plasma concentration and minimum inhibitory concentration (MIC) in both treatment arms

    After blood sample collection is completed samples will be analyzed for plasma concentrations of cefazolin. This concentration will be compared with the standard minimum inhibitory concentration of Cefazolin. It is expected that the difference between AUC and MIC in the continuous infusion group will be higher than the bolus infusion group during the first four hours of surgery.

    First four hours

Secondary Outcomes (3)

  • Difference in AUC of plasma concentration between the two regimens for the entire duration of surgery

    Duration of surgery

  • Total dose of cefazolin administered during the surgery

    Duration of surgery

  • Total dose of cefazolin administered during the first 24 hours

    24 hours after the beginning of surgery

Study Arms (2)

Bolus infusion of Cefazolin

ACTIVE COMPARATOR

Subjects undergoing a ventral hernia repair in this arm of the study will receive the surgical prophylactic, cefazolin, in a bolus infusion

Procedure: Bolus infusion of Cefazolin

Continuous Infusion of Cefazolin

ACTIVE COMPARATOR

Subjects undergoing a ventral hernia repair in this arm of the study will receive the surgical prophylactic, cefazolin, in a continuous infusion

Procedure: Continuous infusion of Cefazolin

Interventions

Bolus infusion of CefazolinPROCEDURE

Subjects in the bolus infusion arm of the study will receive bolus infusions of cefazolin throughout the surgical procedure

Also known as: Bolus infusion
Bolus infusion of Cefazolin
Continuous infusion of CefazolinPROCEDURE

Subjects in the continuous infusion arm of the study will receive a continuous infusion of the cefazolin throughout the surgical procedure

Also known as: Continuous infusion
Continuous Infusion of Cefazolin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • 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

You may not qualify if:

  • Patients unable to give informed consent
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • 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.

    PMID: 13413084BACKGROUND

  • 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.

    PMID: 23489739BACKGROUND

  • 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.

    PMID: 21817889BACKGROUND

  • 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.

    PMID: 20571014BACKGROUND

  • 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.

    PMID: 23461695BACKGROUND

  • 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.

    PMID: 20570290BACKGROUND

  • 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.

    PMID: 26275516BACKGROUND

  • 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.

    PMID: 26039823BACKGROUND

  • 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.

    PMID: 16226938BACKGROUND

  • 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.

    PMID: 12842451BACKGROUND

  • Houck JP, Rypins EB, Sarfeh IJ, Juler GL, Shimoda KJ. Repair of incisional hernia. Surg Gynecol Obstet. 1989 Nov;169(5):397-9.

    PMID: 2530641BACKGROUND

  • 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.

    PMID: 20605590BACKGROUND

  • 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.

    PMID: 22364903BACKGROUND

  • 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.

    PMID: 15175266BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kunal Karamchandani, MD

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesiology

Study Record Dates

First Submitted

January 25, 2016

First Posted

January 28, 2016

Study Start

March 1, 2018

Primary Completion

March 1, 2019

Study Completion

June 1, 2019

Last Updated

May 24, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share