Clinical Trials /

Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)

NCT01479283

Description:

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.

Related Conditions:
  • Bone Neoplasm
  • Bone Sarcoma
  • Metastatic Carcinoma in the Bone
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)
  • Official 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

Clinical Trial IDs

  • ORG STUDY ID: GHRT01
  • NCT ID: NCT01479283

Conditions

  • Infection
  • Bone Neoplasms

Interventions

DrugSynonymsArms
24-Hour Prophylactic Cefazolin* Antibiotic RegimenANCEF ®Short-Arm Antibiotic Regimen
5-Days Prophylactic Cefazolin* Antibiotic RegimenANCEF ®Long-Arm Antibiotic Regimen

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Short-Arm Antibiotic RegimenActive ComparatorIntervention: 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
  • 24-Hour Prophylactic Cefazolin* Antibiotic Regimen
Long-Arm Antibiotic RegimenExperimentalIntervention: 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
  • 5-Days Prophylactic Cefazolin* Antibiotic Regimen

Eligibility Criteria

        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).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:12 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Surgical Site Infections
Time Frame:1 year
Safety Issue:
Description:the development of a surgical site infection according to the criteria established by the Center for Disease Control (CDC)

Secondary Outcome Measures

Measure:Functional Outcome and Quality of Life
Time Frame:1 year
Safety Issue:
Description:as measured by the Musculoskeletal Tumor Society (MSTS) functional score (1987 and 1993 versions) and the Toronto Extremity Salvage Score (TESS) questionnaires
Measure:Antibiotic-Related Complications
Time Frame:1 year
Safety Issue:
Description:examples of antibiotic-related complications include gastrointestinal infections, fungal infections, etc.
Measure:Rate of Re-Operation
Time Frame:1 year
Safety Issue:
Description:re-operation may be required if patients develop a surgical site infection
Measure:Oncologic Recurrence and/or Metastases
Time Frame:1 year
Safety Issue:
Description:
Measure:Mortality
Time Frame:1 year
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:McMaster University

Trial Keywords

  • Infection
  • Bone Neoplasms
  • Prosthesis
  • Anti-Bacterial Agents
  • Randomized

Last Updated

May 23, 2017