Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)



Status:Recruiting
Conditions:Cancer, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Oncology
Healthy:No
Age Range:12 - Any
Updated:4/21/2016
Start Date:January 2013
End Date:December 2019
Contact:Tricia Schneider, B.Sc
Email:schnep@mcmaster.ca
Phone:(905) 527-4322

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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

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.

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.

Inclusion Criteria:

- primary malignant or aggressive benign bone tumors of the lower extremity, or
soft-tissue sarcomas which have invaded the bone; and

- treatment by surgical excision and endoprosthetic replacement.

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);

- prior surgery within the surgical field of the affected limb (excluding biopsy);

- 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 allograft;

- enrolled in a competing study; and

- weight of less than or equal to 45 kg (for sites using cefuroxime only).
We found this trial at
23
sites
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: David Geller, MD, FACS
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Joseph Schwab, MD, FACS
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Boston, MA
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Megan Anderson, MD, FACS
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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Albany, New York 12208
Principal Investigator: Matthew R DiCaprio, MD, FACS
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Albany, NY
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Atlanta, Georgia 30329
Principal Investigator: Nickolas Reimer, MD, FACS
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Atlanta, GA
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Baltimore, Maryland 21215
Principal Investigator: Albert Aboulafia, MD, FACS
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Baltimore, MD
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Baltimore, Maryland 21237
Principal Investigator: Albert Aboulafia, MD, FACS
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Baltimore, MD
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Carol Morris, MD, FACS
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Baltimore, MD
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Megan Anderson, MD, FACS
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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4802 10th Ave
Brooklyn, New York 11219
(718) 283-6000
Principal Investigator: Howard Goodman, MD, FACS
Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
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Brooklyn, NY
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Columbus, Ohio 43210
Principal Investigator: Thomas Scharschmidt, MD, FACS
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Columbus, OH
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East Syracuse, New York 13057
Principal Investigator: Timothy A Damron, MD, FACS
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East Syracuse, NY
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263 Farmington Ave
Farmington, Connecticut 06030
(860) 679-2000
Principal Investigator: Tessa Balach, MD, FACS
University of Connecticut Health Center UConn Health is a vibrant, integrated academic medical center that...
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Farmington, CT
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Iowa City, Iowa 52242
Principal Investigator: Benjamin Miller, MD, FACS
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Iowa City, IA
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Minneapolis, Minnesota 55455
Principal Investigator: Edward Cheng, MD, FACS
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Minneapolis, MN
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Nashville, Tennessee 37212
Principal Investigator: Ginger Holt, MD, FACS
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Nashville, TN
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: John Healey, MD, FACS
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Philadelphia, Pennsylvania 19107
Principal Investigator: John Abraham, MD, FACS
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Philadelphia, PA
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Pilar, Buenos Aires
Principal Investigator: Marcos Galli Serra, MD
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Pilar,
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Kurt Weiss, MD, FACS
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Portland, Oregon 97239
Principal Investigator: Yee-Cheen Doung, MD, FACS
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Portland, OR
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Redwood City, California 94063
Principal Investigator: Raffi Avedian, MD, FACS
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Redwood City, CA
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Salt Lake City, Utah 84112
Principal Investigator: Lor Randall, MD, FACS
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Salt Lake City, UT
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