Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY): Pilot Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by McMaster University
Sponsor:
Collaborators:
Orthopaedic Research and Education Foundation
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Michelle Ghert, McMaster University
ClinicalTrials.gov Identifier:
NCT01479283
First received: November 15, 2011
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to determine whether, in patients undergoing primary bone tumor surgery, long-term (5 days)postoperative antibiotic regimens are more effective at decreasing the rate of infection when compared to short-term (24 hours) postoperative antibiotic regimens.


Condition Intervention Phase
Infection
Bone Neoplasms
Procedure: Prophylactic Cefazolin Antibiotic Regimen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY): A Multi-Center Pilot Study Comparing Alternative Antibiotic Regimens in Patients Undergoing Tumor Resections With Endoprosthetic Replacements

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • number of infections [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    the development of deep infection at the surgical site involving the prosthesis


Secondary Outcome Measures:
  • functional outcome and quality of life as measured by the MSTS-93 and TESS questionnaires [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • number of antibiotic-related complications [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    examples of antibiotic-related complications: gastrointestinal infections, fungal infections, etc.

  • rate of re-operation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    re-operation may be required if patients develop a deep surgical site infection


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 24 hours antibiotics
cefazolin standard dosing
Procedure: Prophylactic Cefazolin Antibiotic Regimen
2g of a first-generation cephalosporin administered intravenously, every 8 hours, for 24 hours or 5 days postoperatively
Other Name: ANCEF ®
Experimental: 5 days antibiotics
cefazolin standard dosing
Procedure: Prophylactic Cefazolin Antibiotic Regimen
2g of a first-generation cephalosporin administered intravenously, every 8 hours, for 24 hours or 5 days postoperatively
Other Name: ANCEF ®

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479283

Contacts
Contact: Antonella Racano, M.Sc. (905) 521-2100 ext 43807 racanoa@mcmaster.ca

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Megan Anderson, MD, FACS         
Sub-Investigator: Mark Gebhardt, MD, FACS         
Boston Children's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Megan Anderson, MD, FACS         
Sub-Investigator: Mark Gebhardt, MD, FACS         
United States, New York
Memorial Sloan-Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
Principal Investigator: John Healey, MD, FACS         
United States, Tennessee
Vanderbilt Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232-8774
Principal Investigator: Ginger Holt, MD, FACS         
United States, Utah
Huntsman Cancer Institute Not yet recruiting
Salt Lake City, Utah, United States, 84112
Principal Investigator: Lor Randall, MD, FACS         
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Principal Investigator: Paul Clarkson, MD, FRCSC         
Canada, Ontario
Juravinski Hospital and Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Principal Investigator: Michelle Ghert, MD, FRCSC         
Sub-Investigator: Benjamin Deheshi, MD, FRCSC         
Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Principal Investigator: Joel Werier, MD, FRCSC         
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Principal Investigator: Peter Ferguson, MD, FRCSC         
Sub-Investigator: Jay Wunder, MD, FRCSC         
Canada, Quebec
McGill University Health Centre Not yet recruiting
Montreal, Quebec, Canada, H3G 1A4
Principal Investigator: Robert Turcotte, MD, FRCSC         
Maisonneuve-Rosemont Hospital Recruiting
Montreal, Quebec, Canada, H1T4B3
Principal Investigator: Marc Isler, MD, FRCSC         
Sub-Investigator: Sophie Mottard, MD, FRCSC         
Sponsors and Collaborators
McMaster University
Orthopaedic Research and Education Foundation
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Michelle Ghert, MD, FRCSC McMaster University
  More Information

Publications:
Responsible Party: Michelle Ghert, Associate Professor, McMaster University
ClinicalTrials.gov Identifier: NCT01479283     History of Changes
Other Study ID Numbers: GHRT01
Study First Received: November 15, 2011
Last Updated: January 18, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Infection
Bone Neoplasms
Prosthesis
Anti Bacterial Agents
Randomized

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Neoplasms
Infection
Bone Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Cefazolin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on September 16, 2014