Trial record 5 of 74 for:
Open Studies | "Bone Neoplasms"
Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY): Pilot Study
This study is currently recruiting participants.
Verified January 2013 by McMaster University
Sponsor:
McMaster University
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
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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
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:
|
Bone Neoplasms Neoplasms Neoplasms by Site Bone Diseases Musculoskeletal Diseases |
Anti-Bacterial Agents Cefazolin Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013