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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01479283




Registration number
NCT01479283
Ethics application status
Date submitted
15/11/2011
Date registered
24/11/2011
Date last updated
8/11/2019

Titles & IDs
Public title
Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)
Scientific title
Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY): A Multi-Center International Randomized Controlled Trial Comparing Alternative Antibiotic Regimens in Patients Undergoing Tumor Resections With Endoprosthetic Replacements
Secondary ID [1] 0 0
GHRT01
Universal Trial Number (UTN)
Trial acronym
PARITY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infection 0 0
Bone Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Children's - Other

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 24-Hour Prophylactic Cefazolin* Antibiotic Regimen
Treatment: Drugs - 5-Days Prophylactic Cefazolin* Antibiotic Regimen

Active Comparator: Short-Arm Antibiotic Regimen - Intervention: 24-Hour Prophylactic Cefazolin* Antibiotic Regimen
*or another cephalosporin with equivalent gram-positive coverage in centers where cefazolin is not routinely used or not approved for use

Experimental: Long-Arm Antibiotic Regimen - Intervention: 5-Days Prophylactic Cefazolin* Antibiotic Regimen
*or another cephalosporin with equivalent gram-positive coverage in centers where cefazolin is not routinely used or not approved for use


Treatment: Drugs: 24-Hour Prophylactic Cefazolin* Antibiotic Regimen
Pre-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if < 18 years old) of IV cefazolin within 60 minutes prior to the procedure. No other pre-operative antibiotics will be administered.
Intra-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if < 18 years old) of IV cefazolin every 3-4 hours. No other intra-operative antibiotics will be administered.
Post-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if < 18 years old) of IV cefazolin every 8 hours for 24 hours followed by IV saline for 4 days. No other post-operative antibiotics will be administered.

Treatment: Drugs: 5-Days Prophylactic Cefazolin* Antibiotic Regimen
Pre-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if < 18 years old) of IV cefazolin within 60 minutes prior to the procedure. No other pre-operative antibiotics will be administered.
Intra-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if < 18 years old) of IV cefazolin every 3-4 hours. No other intra-operative antibiotics will be administered.
Post-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if < 18 years old) of IV cefazolin every 8 hours for 5 days. No other post-operative antibiotics will be administered.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Surgical Site Infections - the development of a surgical site infection according to the criteria established by the Center for Disease Control (CDC)
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Functional Outcome and Quality of Life - as measured by the Musculoskeletal Tumor Society (MSTS) functional score (1987 and 1993 versions) and the Toronto Extremity Salvage Score (TESS) questionnaires
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Antibiotic-Related Complications - examples of antibiotic-related complications include gastrointestinal infections, fungal infections, etc.
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Rate of Re-Operation - re-operation may be required if patients develop a surgical site infection
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Oncologic Recurrence and/or Metastases
Timepoint [4] 0 0
1 year
Secondary outcome [5] 0 0
Mortality
Timepoint [5] 0 0
1 year

Eligibility
Key inclusion criteria
- primary bone malignancies or aggressive benign bone tumors of the femur or tibia,
soft-tissue sarcomas which have invaded the femur or tibia, or oligometastatic bone
disease of the femur or tibia in a patient expected to live at least one year
post-operatively; and

- treatment by surgical excision and endoprosthetic replacement of the femur or tibia.
Minimum age
12 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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);

- current surgical procedure is a revision surgery for implant failure or infection;

- 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 structural allograft;

- enrolled in a competing study; and

- weight of less than or equal to 45 kg (for sites using cefuroxime only).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New Hampshire
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
Wisconsin
Country [19] 0 0
Argentina
State/province [19] 0 0
Buenos Aires
Country [20] 0 0
Austria
State/province [20] 0 0
Graz
Country [21] 0 0
Brazil
State/province [21] 0 0
Porto Alegre
Country [22] 0 0
Brazil
State/province [22] 0 0
São Paulo
Country [23] 0 0
Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
Canada
State/province [24] 0 0
British Columbia
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Egypt
State/province [27] 0 0
Cairo
Country [28] 0 0
India
State/province [28] 0 0
Delhi
Country [29] 0 0
Netherlands
State/province [29] 0 0
South Holland
Country [30] 0 0
Netherlands
State/province [30] 0 0
Groningen
Country [31] 0 0
Singapore
State/province [31] 0 0
Singapore
Country [32] 0 0
South Africa
State/province [32] 0 0
Pietermaritzburg
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Other
Name
McMaster University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Orthopedic Research and Education Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The Physicians' Services Incorporated Foundation
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Canadian Cancer Society Research Institute (CCSRI)
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Canadian Institutes of Health Research (CIHR)
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) trial is the first ever
international multi-center randomized controlled trial in bone cancer surgery. In order to
avoid amputation for bone cancer in the leg, complex limb-saving operations are performed.
However, infections with devastating complications following surgery are common. Surgeons
from across the world will randomize patients to receive either short- or long-duration
antibiotic regimens after surgery with the goal of identifying the best regimen to reduce
these infections.
Trial website
https://clinicaltrials.gov/show/NCT01479283
Trial related presentations / publications
Hasan K, Racano A, Deheshi B, Farrokhyar F, Wunder J, Ferguson P, Holt G, Schwartz H, Petrisor B, Bhandari M, Ghert M. Prophylactic antibiotic regimens in tumor surgery (PARITY) survey. BMC Musculoskelet Disord. 2012 Jun 7;13:91. doi: 10.1186/1471-2474-13-91.
Ghert M, Deheshi B, Holt G, Randall RL, Ferguson P, Wunder J, Turcotte R, Werier J, Clarkson P, Damron T, Benevenia J, Anderson M, Gebhardt M, Isler M, Mottard S, Healey J, Evaniew N, Racano A, Sprague S, Swinton M, Bryant D, Thabane L, Guyatt G, Bhandari M; PARITY Investigators. Prophylactic antibiotic regimens in tumour surgery (PARITY): protocol for a multicentre randomised controlled study. BMJ Open. 2012 Nov 28;2(6). pii: e002197. doi: 10.1136/bmjopen-2012-002197. Print 2012.
Racano A, Pazionis T, Farrokhyar F, Deheshi B, Ghert M. High infection rate outcomes in long-bone tumor surgery with endoprosthetic reconstruction in adults: a systematic review. Clin Orthop Relat Res. 2013 Jun;471(6):2017-27. doi: 10.1007/s11999-013-2842-9. Epub 2013 Feb 12. Review.
Evaniew N, Nuttall J, Farrokhyar F, Bhandari M, Ghert M. What are the levels of evidence on which we base decisions for surgical management of lower extremity bone tumors? Clin Orthop Relat Res. 2014 Jan;472(1):8-15. doi: 10.1007/s11999-013-3311-1. Epub 2013 Oct 1. Review.
Public notes

Contacts
Principal investigator
Name 0 0
Michelle Ghert, MD, FRCSC
Address 0 0
McMaster University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications