Spots Global Cancer Trial Database for Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
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
Study ID: NCT01479283
Study Description
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.
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
Stanford University Hospital and Clinics, Redwood City, California, United States
UC Davis Comprehensive Cancer Center, Sacramento, California, United States
University of California San Francisco Medical Center, San Francisco, California, United States
University of Connecticut Health Center, Farmington, Connecticut, United States
Hartford Hospital, Hartford, Connecticut, United States
University of Florida Health Shands Hospital, Gainesville, Florida, United States
Emory Orthopaedics and Spine Center, Atlanta, Georgia, United States
Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
University of Maryland Medical Center, Baltimore, Maryland, United States
Sinai Hospital of Baltimore, 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
University of Minnesota Medical Center, Minneapolis, Minnesota, United States
Saint Louis University Hospital, Saint Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Albany Medical Center, Albany, New York, United States
Montefiore Medical Center, Bronx, New York, United States
SUNY Upstate University Hospital, East Syracuse, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Long Island Jewish Medical Center | Northwell Health, Queens, New York, United States
Cincinnati Children's Hospital, Cincinnati, Ohio, United States
The Cleveland Clinic - Hillcrest Hospital, Cleveland, Ohio, United States
Wexner Medical Center, Columbus, Ohio, United States
Oregon Health & Science University Hospital, Portland, Oregon, United States
The Rothman Institute at Jefferson, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Vanderbilt Medical Center, Nashville, Tennessee, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Medical College of Wisconsin - Froedtert Hospital, Milwaukee, Wisconsin, United States
Hospital Universitario Austral, Pilar, Buenos Aires, Argentina
Royal Adelaide Hospital, Adelaide, South Australia, Australia
LKH - Universitätsklinikum Graz, Graz, , Austria
Hospital de Clínicas de Porto Alegre, Porto Alegre, , Brazil
Instituto de Ortopedia e Traumatologia, São Paulo, , Brazil
Foothills Medical Centre, Calgary, Alberta, Canada
Vancouver General Hospital, Vancouver, British Columbia, Canada
Juravinski Hospital and Cancer Centre, Hamilton, Ontario, Canada
Ottawa Hospital, Ottawa, Ontario, Canada
Mount Sinai Hospital, Toronto, Ontario, Canada
Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada
McGill University Health Centre, Montreal, Quebec, Canada
Hôtel-Dieu de Québec, Québec City, Quebec, Canada
Children's Cancer Hospital Egypt, Cairo, , Egypt
All India Institute of Medical Sciences, New Delhi, Delhi, India
Leiden University Medical Center, Leiden, South Holland, Netherlands
University Medical Center Groningen, Groningen, , Netherlands
Singapore General Hospital, Singapore, , Singapore
Grey's Hospital, Pietermaritzburg, , South Africa
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Contact Details
Name: Michelle Ghert, MD, FRCSC
Affiliation: McMaster University
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
