Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)
- Conditions
- Bone NeoplasmsInfection
- Interventions
- Drug: 24-Hour Prophylactic Cefazolin* Antibiotic RegimenDrug: 5-Days Prophylactic Cefazolin* Antibiotic Regimen
- Registration Number
- NCT01479283
- Lead Sponsor
- McMaster University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 602
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Short-Arm Antibiotic Regimen 24-Hour Prophylactic Cefazolin* 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 Long-Arm Antibiotic Regimen 5-Days Prophylactic Cefazolin* 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
- Primary Outcome Measures
Name Time Method Surgical Site Infections 1 year the development of a surgical site infection according to the criteria established by the Center for Disease Control (CDC)
- Secondary Outcome Measures
Name Time Method Oncologic Recurrence and/or Metastases 1 year Mortality 1 year Rate of Re-Operation 1 year re-operation may be required if patients develop a surgical site infection
Antibiotic-Related Complications 1 year examples of antibiotic-related complications include gastrointestinal infections, fungal infections, etc.
Functional Outcome and Quality of Life 1 year as measured by the Musculoskeletal Tumor Society (MSTS) functional score (1987 and 1993 versions) and the Toronto Extremity Salvage Score (TESS) questionnaires
Trial Locations
- Locations (54)
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
Stanford University Hospital and Clinics
🇺🇸Redwood City, California, United States
Emory Orthopaedics and Spine Center
🇺🇸Atlanta, Georgia, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
SUNY Upstate University Hospital
🇺🇸East Syracuse, New York, United States
The Cleveland Clinic - Hillcrest Hospital
🇺🇸Cleveland, Ohio, United States
Wexner Medical Center
🇺🇸Columbus, Ohio, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Franklin Square Medical Center
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Instituto de Ortopedia e Traumatologia
🇧🇷São Paulo, Brazil
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Maisonneuve-Rosemont Hospital
🇨🇦Montreal, Quebec, Canada
Children's Cancer Hospital Egypt
🇪🇬Cairo, Egypt
Leiden University Medical Center
🇳🇱Leiden, South Holland, Netherlands
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
University of California San Francisco Medical Center
🇺🇸San Francisco, California, United States
University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Vanderbilt Medical Center
🇺🇸Nashville, Tennessee, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Hôtel-Dieu de Québec
🇨🇦Québec City, Quebec, Canada
Oregon Health & Science University Hospital
🇺🇸Portland, Oregon, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
Albany Medical Center
🇺🇸Albany, New York, United States
The Rothman Institute at Jefferson
🇺🇸Philadelphia, Pennsylvania, United States
Saint Louis University Hospital
🇺🇸Saint Louis, Missouri, United States
Long Island Jewish Medical Center | Northwell Health
🇺🇸Queens, New York, United States
LKH - Universitätsklinikum Graz
🇦🇹Graz, Austria
Hospital Universitario Austral
🇦🇷Pilar, Buenos Aires, Argentina
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Hospital de ClÃnicas de Porto Alegre
🇧🇷Porto Alegre, Brazil
Juravinski Hospital and Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Singapore General Hospital
🇸🇬Singapore, Singapore
All India Institute of Medical Sciences
🇮🇳New Delhi, Delhi, India
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Grey's Hospital
🇿🇦Pietermaritzburg, South Africa
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Medical College of Wisconsin - Froedtert Hospital
🇺🇸Milwaukee, Wisconsin, United States
UC Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
University of Florida Health Shands Hospital
🇺🇸Gainesville, Florida, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States