Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY): A Multi-Center Pilot Study Comparing Alternative Antibiotic Regimens in Patients Undergoing Tumor Resections With Endoprosthetic Replacements
15 Years
N/A
Both
Infection, Bone Neoplasms
Trial Information
Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY): A Multi-Center Pilot Study Comparing Alternative Antibiotic Regimens in Patients Undergoing Tumor Resections With Endoprosthetic Replacements
Deep infection following endoprosthetic limb reconstruction for sarcoma of the long bones is
a devastating complication. The most effective antibiotic regimen in preventing
postoperative deep infections remains controversial. Moreover, the current state of practice
varies widely, particularly with respect to duration of antibiotics. Our multicenter pilot
trial will compare the effect of administering 24 hours versus 5 days of prophylactic
antibiotics on the development of deep endoprosthetic infection in patients undergoing bone
tumor surgery.
Inclusion Criteria:
- primary malignant or aggressive benign bone tumors of the lower extremity
- treated by surgical excision and endoprosthetic replacement
Exclusion Criteria:
- current known Methicillin-resistant Staphylococcus Aureus (MRSA)colonization
- current known Vancomycin Resistant Enterococcus (VRE)colonization
- documented anaphylaxis or angioedema to penicillin or cefazolin (Ancef)
- prior surgery within the surgical field of the affected limb
- prior local infection within the surgical field of the affected limb
- current known immunologically-deficient disease conditions (not including recent
chemotherapy)
- known renal insufficiency with estimated creatinine clearance (eGRF) of less than 54
mL/min
- reconstruction to include allograft
- enrolled in a competing study
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
number of infections
Outcome Description:
the development of deep infection at the surgical site involving the prosthesis
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Michelle Ghert, MD, FRCSC
Investigator Role:
Principal Investigator
Investigator Affiliation:
McMaster University
Authority:
Canada: Ethics Review Committee
Study ID:
GHRT01
NCT ID:
NCT01479283
Start Date:
January 2013
Completion Date:
December 2014
Related Keywords:
- Infection
- Bone Neoplasms
- Infection
- Bone Neoplasms
- Prosthesis
- Anti Bacterial Agents
- Randomized
- Bone Neoplasms
- Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| Vanderbilt Medical Center | Nashville, Tennessee 37232-2765 |
| Boston Children's Hospital | Boston, Massachusetts 02115 |
