NCT02717273

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

July 17, 2018

Completed
Last Updated

July 17, 2018

Status Verified

June 1, 2018

Enrollment Period

6.6 years

First QC Date

March 2, 2016

Results QC Date

May 18, 2018

Last Update Submit

June 18, 2018

Conditions

Liver TransplantationSurgical Site Infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Number of Subjects With Post-operative Fever

    24 hours from surgery

  • Number of Subjects With Elevated White Blood Count (WBC)

    24 hours from surgery

  • Number of Subjects With Nosocomial Infection

    within 30 days from surgery

  • Length of Hospital Stay

    within 30 days from surgery

  • Number of Subjects With Graft Loss

    within 30 days from surgery

  • +1 more secondary outcomes

Study Arms (2)

standard peri-operative antibiotics

ACTIVE COMPARATOR

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: standardOther: liver transplant

extended three-day course of antibiotics

EXPERIMENTAL

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: extendedOther: liver transplant

Interventions

standardDRUG

peri-operative antibiotic regimen only

Also known as: Peri-operative only antibiotics
standard peri-operative antibiotics
extendedDRUG

extended three-day course of antibiotics

Also known as: Extended, three-day antibiotics
extended three-day course of antibiotics
liver transplantOTHER

orthotopic liver transplantation

extended three-day course of antibioticsstandard peri-operative antibiotics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients ≥ 18 years of age.
  • Eligible for liver transplantation by UVA standard protocol.
  • First-time transplantation.
  • No active infections - requiring antibiotics - excluding antifungals.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32799356DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Anti-Bacterial AgentsLiver Transplantation

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesTissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsDigestive System Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantation

Results Point of Contact

Title
Robert Sawyer
Organization
University of Virginia
rws2k@virginia.edu
4349821632

Study Officials

  • Robert G Sawyer, MD

    UVA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profesor of Surgery

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 23, 2016

Study Start

March 1, 2009

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

July 17, 2018

Results First Posted

July 17, 2018

Record last verified: 2018-06