Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717273
• Other study ID #: IRB-HSR#14971
• Secondary ID: T32AI078875
• Status: Completed
• Phase: Phase 3
• Start date: March 2009
• Est. completion date: October 2015

Study information

• Verified date: June 2018
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Liver Transplantation
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• standard
peri-operative antibiotic regimen only
• extended
extended three-day course of antibiotics

Other:
• liver transplant
orthotopic liver transplantation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	National Institute of Allergy and Infectious Diseases (NIAID)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Length of Hospital Stay	days hospitalized after liver transplant	within 30 days from surgery
Secondary	Number of Subjects With Graft Loss	complete loss of liver function in recipient	within 30 days from surgery
Secondary	Number of Subjects With Mortality	death within 30 days of liver transplant	within 30 days from surgery