Continuous v Bolus Infusion of Cefazolin During Ventral Hernia Repair

Phase 4

Withdrawn

• Conditions: Surgical Site Infections
• Interventions: Procedure: Bolus infusion of Cefazolin; Procedure: Continuous infusion of Cefazolin

• Registration Number: NCT02666365
• Lead Sponsor: Milton S. Hershey Medical Center

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)

Study Timeline

• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-01-25
• Study First Posted: 2016-01-28
• Study Start: 2018-03
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-22
• Last Update Posted: 2018-05-24
• Primary Completion: 2019-03
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bolus infusion of Cefazolin	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
Continuous Infusion of Cefazolin	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

Primary Outcome Measures

Name	Time	Method
Difference in Area Under Curve (AUC) of Cefazolin plasma concentration and minimum inhibitory concentration (MIC) in both treatment arms	First four hours	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

Name	Time	Method
Total dose of cefazolin administered during the first 24 hours	24 hours after the beginning of surgery
Difference in AUC of plasma concentration between the two regimens for the entire duration of surgery	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	Duration of surgery