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Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) (PARITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01479283
Recruitment Status : Active, not recruiting
First Posted : November 24, 2011
Last Update Posted : November 8, 2019
Sponsor:
Collaborators:
Orthopedic Research and Education Foundation
The Physicians' Services Incorporated Foundation
Canadian Cancer Society Research Institute (CCSRI)
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Michelle Ghert, MD, FRCSC, McMaster University

Tracking Information
First Submitted Date  ICMJE November 15, 2011
First Posted Date  ICMJE November 24, 2011
Last Update Posted Date November 8, 2019
Actual Study Start Date  ICMJE January 2013
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2014)
Surgical Site Infections [ Time Frame: 1 year ]
the development of a surgical site infection according to the criteria established by the Center for Disease Control (CDC)
Original Primary Outcome Measures  ICMJE
 (submitted: November 23, 2011)
number of infections [ Time Frame: 1 year ]
the development of deep infection at the surgical site involving the prosthesis
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2014)
  • Functional Outcome and Quality of Life [ Time Frame: 1 year ]
    as measured by the Musculoskeletal Tumor Society (MSTS) functional score (1987 and 1993 versions) and the Toronto Extremity Salvage Score (TESS) questionnaires
  • Antibiotic-Related Complications [ Time Frame: 1 year ]
    examples of antibiotic-related complications include gastrointestinal infections, fungal infections, etc.
  • Rate of Re-Operation [ Time Frame: 1 year ]
    re-operation may be required if patients develop a surgical site infection
  • Oncologic Recurrence and/or Metastases [ Time Frame: 1 year ]
  • Mortality [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2011)
  • functional outcome and quality of life as measured by the MSTS-93 and TESS questionnaires [ Time Frame: 1 year ]
  • number of antibiotic-related complications [ Time Frame: 1 year ]
    examples of antibiotic-related complications: gastrointestinal infections, fungal infections, etc.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)
Official Title  ICMJE 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
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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Infection
  • Bone Neoplasms
Intervention  ICMJE
  • 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.

    Other Name: ANCEF ®
  • Drug: 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.

    Other Name: ANCEF ®
Study Arms  ICMJE
  • 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

    Intervention: Drug: 24-Hour Prophylactic Cefazolin* Antibiotic Regimen
  • 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

    Intervention: Drug: 5-Days Prophylactic Cefazolin* Antibiotic Regimen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 7, 2019)
602
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2011)
100
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Brazil,   Canada,   Egypt,   India,   Netherlands,   Singapore,   South Africa,   Spain,   United States
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT01479283
Other Study ID Numbers  ICMJE GHRT01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Michelle Ghert, MD, FRCSC, McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE
  • Orthopedic Research and Education Foundation
  • The Physicians' Services Incorporated Foundation
  • Canadian Cancer Society Research Institute (CCSRI)
  • Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Michelle Ghert, MD, FRCSC McMaster University
PRS Account McMaster University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP