Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics

Study Overview
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Brief Summary
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This study will be to prospectively determine differences in Surgical Site Infection (SSI) if a prolonged course of post-operative antibiotics are used following liver transplantation.

Detailed Description
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This study will be to prospectively determine differences in SSI if a prolonged course of post-operative antibiotics are used following liver transplantation. All adult patients, admitted to the University of Virginia (UVA) Medical Center for first-time liver transplantation will be randomized to the standard of care of peri-operative antibiotics or extended course of three total days. Patients will be evaluated primarily for the presence of post-operative surgical site infections but also for fever, elevated white blood counts, secondary infections (urinary tract, pneumonia, and blood stream), length of hospital stay, graft loss, and mortality for 30 days after liver transplant.

Official Title
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A Randomized, Prospective Study of Surgical Site Infections in Liver Transplant Patients Receiving Three Days of Peri-operative Antibiotic Prophylaxis Versus Intra-operative Antibiotics Only

Conditions
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Liver Transplantation, Surgical Site Infection

Intervention / Treatment
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* Drug: standard
* Drug: extended
* Other: liver transplant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients ≥ 18 years of age. Eligible for liver transplantation by UVA standard protocol. First-time transplantation. No active infections - requiring antibiotics - excluding antifungals. Exclusion Criteria: All patients < 18 years of age. Previous liver transplantation. Active infections - requiring antibiotics. Allergy to all standard peri-operative antibiotics (piperacillin/tazobactam or UVA standard alternatives for Penicillin allergic patients: ciprofloxacin and vancomycin).

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard peri-operative antibiotics<br>The standard of care at the University of Virginia Medical Center for liver transplantation patients is a 3.375 gram dose of piperacillin / tazobactam (Zosyn®) at the time of induction of anesthesia, though this dose may be adjusted for renal insufficiency. This dose is repeated during the operation every six hours. | Drug: standard<br>* peri-operative antibiotic regimen only<br>* Other names: Peri-operative only antibiotics;Other: liver transplant<br>* orthotopic liver transplantation<br>|
| Experimental: extended three-day course of antibiotics<br>For those patients randomized to the study group, antibiotics will be started as per the usual intra-operative dosing regimen, then continued to provide coverage for 72 hours. This is typically provided as additional doses of 3.375 grams of piperacillin / tazobactam (Zosyn®) every 8 hours for 3 total days (giving a total of 72 hours of antibiotic coverage), though this may be altered based on kidney function. | Drug: extended<br>* extended three-day course of antibiotics<br>* Other names: Extended, three-day antibiotics;Other: liver transplant<br>* orthotopic liver transplantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Development of Surgical Site Infections | development of surgical site infection, including superficial and deep incisional and organ space surgical site infections | within 30 days from surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Post-operative Fever | fever above 38.5 degrees Celsius 24 hours after the end of the liver transplant | 24 hours from surgery | 
| Number of Subjects With Elevated White Blood Count (WBC) | above 15,000 within 24hours after the end of the liver transplant | 24 hours from surgery | 
| Number of Subjects With Nosocomial Infection | diagnosis of any new infection other than an SSI within 30 days from surgery | within 30 days from surgery | 
| Length of Hospital Stay | days hospitalized after liver transplant | within 30 days from surgery | 
| Number of Subjects With Graft Loss | complete loss of liver function in recipient | within 30 days from surgery | 
| Number of Subjects With Mortality | death within 30 days of liver transplant | within 30 days from surgery |