Phase 3
N=102
Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics
Liver Transplantation · Surgical Site Infection
Bottom Line
View on ClinicalTrials.gov: NCT02717273 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Number of Subjects With Development of Surgical Site Infections — 9; 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- standard (Drug); extended (Drug); liver transplant (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Virginia
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Development of Surgical Site Infections |
9; 13 | — |
| SECONDARY Number of Subjects With Post-operative Fever |
6; 7 | — |
| SECONDARY Number of Subjects With Elevated White Blood Count (WBC) |
42; 41 | — |
| SECONDARY Number of Subjects With Nosocomial Infection |
8; 11 | — |
| SECONDARY Length of Hospital Stay |
7.5; 7.5 | — |
| SECONDARY Number of Subjects With Graft Loss |
7; 6 | — |
| SECONDARY Number of Subjects With Mortality |
1; 1 | — |
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.
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).
Data sourced from ClinicalTrials.gov (NCT02717273). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.