An official website of the United States government
Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)
Trial Status: complete
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.
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).
Additional locations may be listed on ClinicalTrials.gov for NCT01479283.
Locations matching your search criteria
United States
Maryland
Baltimore
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Status: Active
Name Not Available
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not Available
New York
Bronx
Montefiore Medical Center-Weiler Hospital
Status: Active
Name Not Available
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 PhasePhase III
Trial Typeprevention
Lead OrganizationMcMaster Children's Hospital at Hamilton Health Sciences
