NCT02666365

Continuous v Bolus Infusion of Cefazolin During Ventral Hernia Repair

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Surgical Site Infections

Interventions

Type	Name	Description
PROCEDURE	Bolus infusion of Cefazolin	Subjects in the bolus infusion arm of the study will receive bolus infusions of cefazolin throughout the surgical procedure
PROCEDURE	Continuous infusion of Cefazolin	Subjects in the continuous infusion arm of the study will receive a continuous infusion of the cefazolin throughout the surgical procedure

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-03-01
• Completion: 2019-06-01
• First posted: 2016-01-28
• Last updated: 2018-05-24

Regulatory

• FDA-regulated drug study