Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics

University of Virginia102 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

102

Conditions

Liver Transplantation Surgical Site Infection

Interventions

standardDRUG

peri-operative antibiotic regimen only

extendedDRUG

extended three-day course of antibiotics

liver transplantOTHER

orthotopic liver transplantation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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

Time frame: within 30 days from surgery

Secondary Outcomes

Number of Subjects With Post-operative Fever

fever above 38.5 degrees Celsius 24 hours after the end of the liver transplant

Time frame: 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

Time frame: 24 hours from surgery

Number of Subjects With Nosocomial Infection

diagnosis of any new infection other than an SSI within 30 days from surgery

Time frame: within 30 days from surgery

Length of Hospital Stay

days hospitalized after liver transplant

Time frame: within 30 days from surgery

Number of Subjects With Graft Loss

complete loss of liver function in recipient

Time frame: within 30 days from surgery

Number of Subjects With Mortality

death within 30 days of liver transplant

Time frame: within 30 days from surgery

Data from ClinicalTrials.gov

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