Surgical Site Infections
Conditions
Keywords
anesthesia, surgical antimicrobial prophylaxis, surgical site infections
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)
Interventions
PROCEDUREBolus infusion of Cefazolin
Subjects in the bolus infusion arm of the study will receive bolus infusions of cefazolin throughout the surgical procedure
PROCEDUREContinuous infusion of Cefazolin
Subjects in the continuous infusion arm of the study will receive a continuous infusion of the cefazolin throughout the surgical procedure
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Total dose of cefazolin administered during the first 24 hours | 24 hours after the beginning of surgery | — |
Outcome results
None listed