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Completed

NCT Number: NCT02717273

Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics

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.

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Key information

Conditions

Liver Transplantation Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Site Infection Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Standard

Drug

peri-operative antibiotic regimen only

Other names: Peri-operative only antibiotics

extended

Drug

extended three-day course of antibiotics

Other names: Extended, three-day antibiotics

liver transplant

Other

orthotopic liver transplantation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Mar 23, 2016
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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