Continuous v Bolus Infusion of Cefazolin During Ventral Hernia Repair

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Surgical Site Infections

Intervention / Treatment
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* Procedure: Bolus infusion of Cefazolin
* Procedure: Continuous infusion of Cefazolin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bolus infusion of Cefazolin<br>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<br>* Subjects in the bolus infusion arm of the study will receive bolus infusions of cefazolin throughout the surgical procedure<br>* Other names: Bolus infusion;|
| Active Comparator: Continuous Infusion of Cefazolin<br>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<br>* Subjects in the continuous infusion arm of the study will receive a continuous infusion of the cefazolin throughout the surgical procedure<br>* Other names: Continuous infusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anesthesia, surgical antimicrobial prophylaxis, surgical site infections