Continuous v Bolus Infusion of Cefazolin During Ventral Hernia Repair

Penn State Health

Status and phase: Withdrawn; Phase 4

Conditions: Surgical Site Infections

Treatments: Procedure: Continuous infusion of Cefazolin; Procedure: Bolus infusion of Cefazolin

Study type: Interventional

Funder types: Other

Identifiers

NCT02666365

STUDY00003845

Details and patient eligibility

About

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.

Full 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)

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Bolus infusion of Cefazolin

Active Comparator group

Description:

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

Treatment:

Procedure: Bolus infusion of Cefazolin

Continuous Infusion of Cefazolin

Active Comparator group

Description:

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

Treatment:

Procedure: Continuous infusion of Cefazolin