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Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY): A Multi-Center Pilot Study Comparing Alternative Antibiotic Regimens in Patients Undergoing Tumor Resections With Endoprosthetic Replacements


Phase 3
15 Years
N/A
Open (Enrolling)
Both
Infection, Bone Neoplasms

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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 CenterNew York, New York  10021
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Vanderbilt Medical CenterNashville, Tennessee  37232-2765
Boston Children's HospitalBoston, Massachusetts  02115