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Surgical Site InfectionsPhase 4NCT02666365

Continuous v Bolus Infusion of Cefazolin During Ventral Hernia Repair

A Phase 4 study testing Bolus infusion of Cefazolin and Continuous infusion of Cefazolin in people with Surgical Site Infections, run by Milton S. Hershey Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgical Site Infections
What is being tested?
Bolus infusion of Cefazolin and Continuous infusion of Cefazolin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Mar 2018to Jun 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: Pharmacokinetic Comparison of Cefazolin Redosing Strategy for Surgical Prophylaxis. Bolus Dose vs Continuous Infusion

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.

Read the 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)

Being tested
Bolus infusion of Cefazolin, Continuous infusion of Cefazolin
Keywords
anesthesia, surgical antimicrobial prophylaxis, surgical site infections
Medical subject headings
Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bolus infusion of CefazolinProcedure or surgery

    Also called Bolus infusion

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

  • Continuous infusion of CefazolinProcedure or surgery

    Also called Continuous infusion

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

Study groups in NCT02666365
Study groupRoleWhat they receive
Bolus infusion of CefazolinActive comparatorSubjects undergoing a ventral hernia repair in this arm of the study will receive the surgical prophylactic, cefazolin, in a bolus infusion
Receives: Procedure: Bolus infusion of Cefazolin
Continuous Infusion of CefazolinActive comparatorSubjects undergoing a ventral hernia repair in this arm of the study will receive the surgical prophylactic, cefazolin, in a continuous infusion
Receives: Procedure: Continuous infusion of Cefazolin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: First four hours

Secondary outcomes (3)

  1. 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.

    Measured: Duration of surgery

  2. Total dose of cefazolin administered during the surgery

    Measured: Duration of surgery

  3. Total dose of cefazolin administered during the first 24 hours

    Measured: 24 hours after the beginning of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2016 (estimated)
  2. Study startMar 2018 (estimated)
  3. Primary completionMar 2019 (estimated)
  4. Study completionJun 2019 (estimated)

Why it stopped: Investigator decided not to proceed.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02666365
Sponsor's protocol ID
STUDY00003845
Status last verified
May 2018
First submitted
25 Jan 2016
Last updated
24 May 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 13413084

  • 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.

    PubMed 23489739

  • 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.

    PubMed 21817889

  • 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.

    PubMed 20571014

  • 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.

    PubMed 23461695

  • 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.

    PubMed 20570290

  • 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.

    PubMed 26275516

  • 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.

    PubMed 26039823

  • 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.

    PubMed 16226938

  • 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.

    PubMed 12842451

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

    PubMed 2530641

  • 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.

    PubMed 20605590

  • 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.

    PubMed 22364903

  • 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.

    PubMed 15175266

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bolus infusion of Cefazolin and Continuous infusion of Cefazolin in people with Surgical Site Infections, run by Milton S. Hershey Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in Area Under Curve (AUC) of Cefazolin plasma concentration and minimum inhibitory concentration (MIC) in both treatment arms (time frame: First four hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02666365, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2018.

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