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Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717273
Recruitment Status : Completed
First Posted : March 23, 2016
Results First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Robert Sawyer, MD, University of Virginia

Brief 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.

Condition or disease Intervention/treatment Phase
Liver Transplantation Surgical Site Infection Drug: standard Drug: extended Other: liver transplant Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2009
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: standard peri-operative antibiotics
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
peri-operative antibiotic regimen only
Other Name: Peri-operative only antibiotics

Other: liver transplant
orthotopic liver transplantation

Experimental: extended three-day course of antibiotics

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
extended three-day course of antibiotics
Other Name: Extended, three-day antibiotics

Other: liver transplant
orthotopic liver transplantation




Primary Outcome Measures :
  1. Number of Subjects With Development of Surgical Site Infections [ Time Frame: within 30 days from surgery ]
    development of surgical site infection, including superficial and deep incisional and organ space surgical site infections


Secondary Outcome Measures :
  1. Number of Subjects With Post-operative Fever [ Time Frame: 24 hours from surgery ]
    fever above 38.5 degrees Celsius 24 hours after the end of the liver transplant

  2. Number of Subjects With Elevated White Blood Count (WBC) [ Time Frame: 24 hours from surgery ]
    above 15,000 within 24hours after the end of the liver transplant

  3. Number of Subjects With Nosocomial Infection [ Time Frame: within 30 days from surgery ]
    diagnosis of any new infection other than an SSI within 30 days from surgery

  4. Length of Hospital Stay [ Time Frame: within 30 days from surgery ]
    days hospitalized after liver transplant

  5. Number of Subjects With Graft Loss [ Time Frame: within 30 days from surgery ]
    complete loss of liver function in recipient

  6. Number of Subjects With Mortality [ Time Frame: within 30 days from surgery ]
    death within 30 days of liver transplant



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717273


Sponsors and Collaborators
University of Virginia
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Robert G Sawyer, MD UVA
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robert Sawyer, MD, Profesor of Surgery, University of Virginia
ClinicalTrials.gov Identifier: NCT02717273    
Other Study ID Numbers: IRB-HSR#14971
T32AI078875 ( U.S. NIH Grant/Contract )
First Posted: March 23, 2016    Key Record Dates
Results First Posted: July 17, 2018
Last Update Posted: July 17, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents