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Continuous v Bolus Infusion of Cefazolin During Ventral Hernia Repair

Primary Purpose

Surgical Site Infections

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bolus infusion of Cefazolin
Continuous infusion of Cefazolin
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infections focused on measuring anesthesia, surgical antimicrobial prophylaxis, surgical site infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Bolus infusion of Cefazolin

    Continuous Infusion of Cefazolin

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Difference in AUC of plasma concentration between the two regimens for the entire duration of surgery
    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 for the entire duration of surgery.
    Total dose of cefazolin administered during the surgery
    Total dose of cefazolin administered during the first 24 hours

    Full Information

    First Posted
    January 25, 2016
    Last Updated
    May 22, 2018
    Sponsor
    Milton S. Hershey Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02666365
    Brief Title
    Continuous v Bolus Infusion of Cefazolin During Ventral Hernia Repair
    Official Title
    Pharmacokinetic Comparison of Cefazolin Redosing Strategy for Surgical Prophylaxis. Bolus Dose vs Continuous Infusion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Investigator decided not to proceed.
    Study Start Date
    March 2018 (Anticipated)
    Primary Completion Date
    March 2019 (Anticipated)
    Study Completion Date
    June 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Milton S. Hershey Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Patients who will be undergoing elective ventral hernia repair will be potential candidates for this study. Once identified, the surgical team will approach the participant for consent and inclusion in the study. On the day of surgery, the subjects will be assigned to either the Bolus Group (CB) or Continuous Infusion Group (CI) according to a randomly generated assignment procedure. During the procedure, the dose of prophylactic Cefazolin will be given an hour before surgery and will be administered in accordance to group assignment. Subjects in the CB will receive bolus infusions of Cefazolin every 4 hours till the end of surgery. Subjects in the CI group will receive an initial bolus injection of Cefazolin followed by a continuous infusion till the closure of skin incision. Blood samples will be taken during surgery at t=0, 15, 30 and 60 minutes and every hour following till the end of surgery or 6 hours (whichever comes sooner)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Surgical Site Infections
    Keywords
    anesthesia, surgical antimicrobial prophylaxis, surgical site infections

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bolus infusion of Cefazolin
    Arm Type
    Active Comparator
    Arm Description
    Subjects undergoing a ventral hernia repair in this arm of the study will receive the surgical prophylactic, cefazolin, in a bolus infusion
    Arm Title
    Continuous Infusion of Cefazolin
    Arm Type
    Active Comparator
    Arm Description
    Subjects undergoing a ventral hernia repair in this arm of the study will receive the surgical prophylactic, cefazolin, in a continuous infusion
    Intervention Type
    Procedure
    Intervention Name(s)
    Bolus infusion of Cefazolin
    Other Intervention Name(s)
    Bolus infusion
    Intervention Description
    Subjects in the bolus infusion arm of the study will receive bolus infusions of cefazolin throughout the surgical procedure
    Intervention Type
    Procedure
    Intervention Name(s)
    Continuous infusion of Cefazolin
    Other Intervention Name(s)
    Continuous infusion
    Intervention Description
    Subjects in the continuous infusion arm of the study will receive a continuous infusion of the cefazolin throughout the surgical procedure
    Primary Outcome Measure Information:
    Title
    Difference in Area Under Curve (AUC) of Cefazolin plasma concentration and minimum inhibitory concentration (MIC) in both treatment arms
    Description
    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.
    Time Frame
    First four hours
    Secondary Outcome Measure Information:
    Title
    Difference in AUC of plasma concentration between the two regimens for the entire duration of surgery
    Description
    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 for the entire duration of surgery.
    Time Frame
    Duration of surgery
    Title
    Total dose of cefazolin administered during the surgery
    Time Frame
    Duration of surgery
    Title
    Total dose of cefazolin administered during the first 24 hours
    Time Frame
    24 hours after the beginning of surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kunal Karamchandani, MD
    Organizational Affiliation
    Milton S. Hershey Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    13413084
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23489739
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21817889
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20571014
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23461695
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20570290
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26275516
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26039823
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16226938
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12842451
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    2530641
    Citation
    Houck JP, Rypins EB, Sarfeh IJ, Juler GL, Shimoda KJ. Repair of incisional hernia. Surg Gynecol Obstet. 1989 Nov;169(5):397-9.
    Results Reference
    background
    PubMed Identifier
    20605590
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22364903
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    15175266
    Citation
    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.
    Results Reference
    background

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    Continuous v Bolus Infusion of Cefazolin During Ventral Hernia Repair

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