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.
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
Interventions
Drug | Synonyms | Arms |
---|
24-Hour Prophylactic Cefazolin* Antibiotic Regimen | ANCEF ® | Short-Arm Antibiotic Regimen |
5-Days Prophylactic Cefazolin* Antibiotic Regimen | ANCEF ® | 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
Name | Type | Description | Interventions |
---|
Short-Arm Antibiotic Regimen | Active Comparator | 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 | - 24-Hour Prophylactic Cefazolin* Antibiotic Regimen
|
Long-Arm Antibiotic Regimen | Experimental | 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 | - 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: | Completed |
Lead Sponsor: | McMaster University |
Trial Keywords
- Infection
- Bone Neoplasms
- Prosthesis
- Anti-Bacterial Agents
- Randomized
Last Updated
March 11, 2021