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ROSEMONT, Ill., Feb. 10, 2023 /PRNewswire/ -- The 2023 Kappa Delta Ann Doner Vaughn Award was given to Michelle Ghert, MD, FRCSC, on behalf of the Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) investigators for their research on the prevention of surgical site infections (SSIs) through antibiotic prophylaxis following oncologic reconstruction surgery for bone tumors. Their work resulted in the first-ever international, multi-center randomized controlled trial (RCT) in orthopaedic oncology as well as the largest collaborative effort in orthopaedic surgery with regards to the number of countries collaborating. To read more about the award, please click here. Continue Reading The 2023 Kappa Delta Ann Doner Vaughn Award was given to Michelle Ghert, MD, FRCSC, on behalf of the Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) investigators for their research on the prevention of surgical site infections (SSIs) through antibiotic prophylaxis following oncologic reconstruction surgery for bone tumors. "In the field of medicine, conducting a 600-patient randomized study isn't out of the ordinary," said Dr. Ghert, principal investigator, professor, Department of Surgery, McMaster University, Hamilton, Ontario, Canada. "However, in orthopaedic oncology, where we treat rare diseases, it was a shift in our research paradigm. While initially there wasn't much optimism that this study would work, we believed it was time to move forward for our patients and the research question really resonated. I give a lot of credit to the first few clinical sites that joined the study as they took a leap of faith." Bone sarcomas – malignant tumors of long bones in the arms or legs – are treated through limb salvage surgery which involves reconstructing the limb with implants.i While bone sarcomas are rare, making up less than 1% of all cancers, these typically affect younger patients.ii SSIs rates are high following surgery as it is a long and complex procedure, and the patient has a compromised immune system due to chemotherapy.i,iii SSIs can be devastating to patients, requiring revision surgery and long-term intravenous antibiotic therapy. Even so, reinfection and eventual amputation are common,iv greatly affecting patients' quality of life and increasing the overall healthcare costs.v To reduce SSIs in orthopaedic reconstruction surgery, antibiotics are used and typically discontinued after 24 hours as dictated by guidelines for other surgical procedures. However, with no studies examining the role of antibiotic regimens for surgical reconstruction of lower extremity bone tumors, there were no firm conclusions regarding antibiotic duration. The PARITY Steering Committee brought experts together from orthopaedic oncology, infectious diseases, clinical epidemiology, biostatistics and health research methodology to lead research on this issue. PARITY Trial Findings Prior to the PARITY trial, the team conducted several supportive studies that helped inform the design, implementation and feasibility of the PARTIY trial, including: a multinational survey of orthopaedic oncologists to determine standard SSI prevention practices a systematic review to determine a baseline SSI rate a trial protocol publication a qualitative study to understand the barriers and facilitators to collaborative perspective research in orthopaedic oncology a pilot randomized trial an assessment of blinded outcomes assessment for SSIs an a priori statistical analysis plan The PARITY trial was conducted across 55 clinical centers in 12 countries as a parallel, blinded RCT from January 2013 to October 2019. The study was led by Dr. Ghert in collaboration with the study lead in Europe, Roberto Velez, MD, PhD. The trial followed 604 patients with primary bone or soft-tissue sarcoma or oligometastatic (a more treatable form of metastatic cancer) bone disease in the femur or tibia with an expected survival of one year who required surgical resection and implant reconstruction. Patients were randomized to a one- or five-day regimen (311 to one day and 293 to five day) of post-operative intravenous antibiotics (cefazolin or cefuroxime) within eight hours of skin closure and then administered every eight hours after that. Patients, caregivers and outcome assessors were blinded to treatment allocation. The primary outcome focus was a SSI (superficial incisional, deep incisional or organ space) within one year and classified according to the Centers for Disease Control and Prevention (CDC) criteria. Additional secondary outcomes included antibiotic-related complications, unplanned reoperations, oncologic and functional outcomes and mortality. Patients were assessed at two and six weeks, three, six and nine months, and one year after surgery. The findings of the PARITY trial included: Fifteen percent of patients allocated to the five-day regimen and 16.7% on the one-day regimen had a SSI. The most common causes of SSIs were Staphylococcus aureus and coagulase-negative Staphylococci. There was a significant increase in antibiotic-related complications in the five-day regimen group, with the main complication reported to be antibiotic-associated diarrhea caused by Clostridioides difficile which can be severe and may lead to toxic megacolon, organ failure or even death.vi Other secondary outcomes didn't differ significantly between treatment groups. "The risk for SSI was not significantly different for five days or one day, so when surgeons write post-operative orders, they have that information to work with," said Dr. Ghert. "However, one of the secondary outcomes demonstrated you could actually hurt the patient by causing severe antibiotic-related complications that can be life altering. When you have a patient who is already going through a very difficult time, chemotherapy and morbid surgery, surgeons need to weigh the risk before prescribing prolonged antibiotics as they can cause added gastrointestinal issues that can be chronic." The PARITY investigators work resulted in 13 manuscripts published in peer-reviewed journals, including The Journal of the American Medical Association (Oncology). Future Use of PARITY Data The PARITY database represents the highest quality of information on a massive scale on the treatment and outcomes of patients undergoing oncologic reconstruction surgery for bone tumors. PARITY investigators and their research team submitted research questions that could be answered through a secondary analysis of the database and a further 13 manuscripts were developed for a special supplement edition of the Journal of Bone and Joint Surgery. These studies look at such issues as patient and treatment risk factors for SSI and reoperation and the incidence and risk factors for thromboembolic events in lower extremity reconstruction. Additionally, the PARITY Writing Committee worked with the editors of JAMA Oncology to release the PARITY data to the public on Jan. 6, 2023, to further the dissemination of the study data. About the Kappa Delta Awards In 1947, at its golden anniversary, the Kappa Delta Sorority established the Kappa Delta Research Fellowship in Orthopaedics, the first award ever created to honor achievements in the field of orthopaedic research. The first annual award, a single stipend of $1,000, was made available to the AAOS in 1949 and presented at the AAOS meeting in 1950. The Kappa Delta Awards have been presented by the AAOS to persons who have performed research in orthopaedic surgery that is of high significance and impact. The sorority has since added two more awards and increased the award amounts to $20,000 each. Two awards are named for the sorority national past presidents who were instrumental in the creation of the awards: Elizabeth Winston Lanier, and Ann Doner Vaughn. The third is known as the Young Investigator Award. For more information about the manuscript submission process, please visit aaos.org/kappadelta. Learn more about the Kappa Delta Foundation, here. About the AAOS With more than 39,000 members, the American Academy of Orthopaedic Surgeons is the world's largest medical association of musculoskeletal specialists. The AAOS is the trusted leader in advancing musculoskeletal health. It provides the highest quality, most comprehensive education to help orthopaedic surgeons and allied health professionals at every career level to best treat patients in their daily practices. The AAOS is the source for information on bone and joint conditions, treatments and related musculoskeletal healthcare issues and it leads the healthcare discussion on advancing quality. Follow the AAOS on Facebook, Twitter, LinkedIn and Instagram. Disclosure Funding The PARITY Project was funded by the Canadian Institutes of Health Research, the Orthopaedic Research and Education Foundation in partnership with the Musculoskeletal Tumor Society, the Canadian Cancer Society Research Institute, Physicians Services Incorporated, the Canadian Orthopaedic Foundation, the Silverhearts Foundation, and the Hamilton Health Sciences New Investigator Fund. i Jeys L, Grimer R. 2009. The Long-Term Risks of Infection and Amputation with Limb Salvage Surgery Using Endoprostheses. In: Tunn P-U, editor. Treatment of Bone and Soft Tissue Sarcomas. Berlin, Heidelberg: Springer. p 75–84. Available from: . ii Mayo Clinic. Bone Cancer. Accessed 1/5/2023. URL: iii Morii T, Yabe H, Morioka H, et al. 2010. Postoperative deep infection in tumor endoprosthesis reconstruction around the knee. J Orthop Sci 15(3):331–339. iv Jeys LM, Grimer RJ, Carter SR, Tillman RM. 2003. Risk of amputation following limb salvage surgery with endoprosthetic replacement, in a consecutive series of 1261 patients. Int Orthop 27(3):160–163. v Akahane T, Shimizu T, Isobe K, et al. 2007. Evaluation of postoperative general quality of life for patients with osteosarcoma around the knee joint. J Pediatr Orthop B 16(4):269–272. vi Mullish BH, Williams HR. 2018. Clostridium difficile infection and antibiotic-associated diarrhea. Clin Med (Lond) 18(3):237–241. SOURCE American Academy of Orthopaedic Surgeons

It’s been a month since Pfizer was forced to recall bottles of its anti-smoking drug Chantix, but the counter was set back to zero last week as the company recalled all of its lots of 0.5 mg and 1 mg tablets due to increased levels of nitrosamines. Distribution of Chantix was stopped in June, and the company recalled four lots of the drug after finding elevated levels of cancer-causing nitrosamines. Then, in July, the FDA said it would still allow certain manufacturers to distribute batches of the drug that have more than the usual nitrosamine levels, so long as it remains under the interim acceptable limit. Officials at Pfizer originally said the drugmaker believed the benefits of the anti-smoking drug outweigh any potential risk of exposure to nitrosamines, and that those who have been taking it should continue to do so. It stuck by that mantra, but the most recent announcement featured extensive information about how to return the distributed batches and stop further distribution. “Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication,” the press release said. “Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time. “ Lots were distributed in the US, US Virgin Islands and Puerto Rico from May 2019 to September 2021. There’s a nitrosamine problem that goes deeper than just at Pfizer. Last year, the FDA found high levels of NDMA in some versions of generic diabetes drug metformin. Before Pfizer, Viona Pharmaceuticals issued a recall for two lots of its 750 mg extended-release metformin tablets, and since November 2020, there have been two more drugs recalled because of reports of NDMA. In 2018, drug pressure drug valsartan was pulled for the same reason. IntegraDose Compounding Services also announced Wednesday it would voluntarily recall nine lots of cefazolin for injection and two lots of cefazolin for injection, following issues of sterility. The lots all have expiration dates between Sept. 17, 2021, and Sept. 26, 2021.