Clinical trial NCT02717273: Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Transplantation
Surgical Site Infection
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2016-03-23
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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).

Primary outcomes:
measure: Number of Subjects With Development of Surgical Site Infections
timeFrame: within 30 days from surgery
Secondary outcomes:
measure: Number of Subjects With Post-operative Fever
timeFrame: 24 hours from surgery
measure: Number of Subjects With Elevated White Blood Count (WBC)
timeFrame: 24 hours from surgery
measure: Number of Subjects With Nosocomial Infection
timeFrame: within 30 days from surgery
measure: Length of Hospital Stay
timeFrame: within 30 days from surgery
measure: Number of Subjects With Graft Loss
timeFrame: within 30 days from surgery
measure: Number of Subjects With Mortality
timeFrame: within 30 days from surgery
Other outcomes:
Locations:
Study officials:
affiliation: UVA
name: Robert G Sawyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan S, Ng S, Chan HP, Pascoe EM, Playford EG, Wong G, Chapman JR, Lim WH, Francis RS, Isbel NM, Campbell SB, Hawley CM, Johnson DW. Perioperative antibiotics for preventing post-surgical site infections in solid organ transplant recipients. Cochrane Database Syst Rev. 2020 Aug 4;8(8):CD013209. doi: 10.1002/14651858.CD013209.pub2.