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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01479283
Other study ID # GHRT01
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 2013
Est. completion date March 2021

Study information

Verified date March 2021
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Long-bone sarcomas were historically managed with amputation. In the current era of osteosarcoma management, amputations are generally avoided by complex surgeries in which the malignancy is removed and the limb is reconstructed with advanced surgical techniques. This process of limb salvage is possible with improvements in chemotherapeutic regimens, advanced imaging techniques and surgical innovations such as modular metallic implants. However, the risk for surgical complications is high due to the complexity of the surgeries themselves. The most common and devastating complication is a surgical site infection. Background work and data from our pilot study indicates that infection rates approach 15%. Multiple surgical attempts at eradication of the infection fail in 50% of these cases, resulting in amputation. Published guidelines for post-operative antibiotic prophylaxis following many standard and less complex elective surgical procedures dictate that prophylactic antibiotics be discontinued after 24 hours. However, the most effective duration of treatment in sarcoma surgery has not previously been examined. Given the limitations of the evidence, it has not been possible for orthopaedic oncologists to draw firm conclusions and, therefore, clinical practice is highly varied, particularly with respect to antibiotic duration. Our international, multi-center randomized controlled trial will determine whether a 5-day regimen of post-operative prophylactic antibiotics in comparison to a standard 24-hour regimen decreases the rate of surgical site infections after limb salvage surgery within 1-year follow-up.


Recruitment information / eligibility

Status Completed
Enrollment 602
Est. completion date March 2021
Est. primary completion date March 2021
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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. 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


Related Conditions & MeSH terms


Intervention

Drug:
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.
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.

Locations

Country Name City State
Argentina Hospital Universitario Austral Pilar Buenos Aires
Australia Royal Adelaide Hospital Adelaide South Australia
Austria LKH - Universitätsklinikum Graz Graz
Brazil Hospital de Clínicas de Porto Alegre Porto Alegre
Brazil Instituto de Ortopedia e Traumatologia São Paulo
Canada Foothills Medical Centre Calgary Alberta
Canada Juravinski Hospital and Cancer Centre Hamilton Ontario
Canada Maisonneuve-Rosemont Hospital Montreal Quebec
Canada McGill University Health Centre Montreal Quebec
Canada Ottawa Hospital Ottawa Ontario
Canada Hôtel-Dieu de Québec Québec City Quebec
Canada Mount Sinai Hospital Toronto Ontario
Canada Vancouver General Hospital Vancouver British Columbia
Egypt Children's Cancer Hospital Egypt Cairo
India All India Institute of Medical Sciences New Delhi Delhi
Netherlands University Medical Center Groningen Groningen
Netherlands Leiden University Medical Center Leiden South Holland
Singapore Singapore General Hospital Singapore
South Africa Grey's Hospital Pietermaritzburg
Spain Hospital Universitari Vall d'Hebron Barcelona
United States Albany Medical Center Albany New York
United States Emory Orthopaedics and Spine Center Atlanta Georgia
United States Franklin Square Medical Center Baltimore Maryland
United States Johns Hopkins Hospital Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States University of Maryland Medical Center Baltimore Maryland
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Boston Children's Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States Cincinnati Children's Hospital Cincinnati Ohio
United States The Cleveland Clinic - Hillcrest Hospital Cleveland Ohio
United States Wexner Medical Center Columbus Ohio
United States SUNY Upstate University Hospital East Syracuse New York
United States University of Connecticut Health Center Farmington Connecticut
United States University of Florida Health Shands Hospital Gainesville Florida
United States Hartford Hospital Hartford Connecticut
United States Holden Comprehensive Cancer Center Iowa City Iowa
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Ronald Reagan UCLA Medical Center Los Angeles California
United States Medical College of Wisconsin - Froedtert Hospital Milwaukee Wisconsin
United States University of Minnesota Medical Center Minneapolis Minnesota
United States Vanderbilt Medical Center Nashville Tennessee
United States Memorial Sloan-Kettering Cancer Center New York New York
United States The Rothman Institute at Jefferson Philadelphia Pennsylvania
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Oregon Health & Science University Hospital Portland Oregon
United States Long Island Jewish Medical Center | Northwell Health Queens New York
United States Stanford University Hospital and Clinics Redwood City California
United States UC Davis Comprehensive Cancer Center Sacramento California
United States Saint Louis University Hospital Saint Louis Missouri
United States Huntsman Cancer Institute Salt Lake City Utah
United States University of California San Francisco Medical Center San Francisco California

Sponsors (5)

Lead Sponsor Collaborator
McMaster University Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR), Orthopedic Research and Education Foundation, The Physicians' Services Incorporated Foundation

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Brazil,  Canada,  Egypt,  India,  Netherlands,  Singapore,  South Africa,  Spain, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Surgical Site Infections the development of a surgical site infection according to the criteria established by the Center for Disease Control (CDC) 1 year
Secondary 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 1 year
Secondary Antibiotic-Related Complications examples of antibiotic-related complications include gastrointestinal infections, fungal infections, etc. 1 year
Secondary Rate of Re-Operation re-operation may be required if patients develop a surgical site infection 1 year
Secondary Oncologic Recurrence and/or Metastases 1 year
Secondary Mortality 1 year
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