Prophylactic antibiotic regimens in tumour surgery (PARITY): Protocol for a multicentre randomised controlled study

Michelle Ghert, Benjamin Deheshi, Ginger Holt, R. Lor Randall, Peter Ferguson, Jay Wunder, Robert Turcotte, Joel Werier, Paul Clarkson, Timothy Damron, Joseph Benevenia, Megan Anderson, Mark Gebhardt, Marc Isler, Sophie Mottard, John Healey, Nathan Evaniew, Antonella Racano, Sheila Sprague, Marilyn SwintonDianne Bryant, Lehana Thabane, Gordon Guyatt, Mohit Bhandari

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

Introduction: Limb salvage with endoprosthetic reconstruction is the standard of care for the management of lower-extremity bone tumours in skeletally mature patients. The risk of deep postoperative infection in these procedures is high and the outcomes can be devastating. The most effective prophylactic antibiotic regimen remains unknown, and current clinical practice is highly varied. This trial will evaluate the effect of varying postoperative prophylactic antibiotic regimens on the incidence of deep infection following surgical excision and endoprosthetic reconstruction of lower-extremity bone tumours. Methods and analysis: This is a multicentre, blinded, randomised controlled trial, using a parallel two-arm design. 920 patients 15 years of age or older from 12 tertiary care centres across Canada and the USA who are undergoing surgical excision and endoprosthetic reconstruction of a primary bone tumour will receive either short (24 h) or long (5 days) duration postoperative antibiotics. Exclusion criteria include prior surgery or infection within the planned operative field, known colonisation with methicillinresistant Staphylococcus aureus or vancomycinresistant Enterococcus at enrolment, or allergy to the study antibiotics. The primary outcome will be rates of deep postoperative infections in each arm. Secondary outcomes will include type and frequency of antibioticrelated adverse events, patient functional outcomes and quality-of-life scores, reoperation and mortality. Randomisation will be blocked, with block sizes known only to the methods centre responsible for randomisation, and stratified by location of tumour and study centre. Patients, care givers and a Central Adjudication Committee will be blinded to treatment allocation. The analysis to compare groups will be performed using Cox regression and log-rank tests to compare survival functions at α=0.05. Ethics and dissemination: This study has ethics approval from the McMaster University/Hamilton Health Sciences Research Ethics Board (REB# 12-009). Successful completion will significantly impact on clinical practice and enhance patients' lives. More broadly, this trial will develop a network of collaboration from which further high-quality trials in Orthopaedic Oncology will follow.

Original languageEnglish (US)
Article numbere002197
JournalBMJ open
Volume2
Issue number6
DOIs
StatePublished - Dec 1 2012

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Bones of Lower Extremity
Anti-Bacterial Agents
Random Allocation
Infection
Ethics
Neoplasms
Research Ethics
Limb Salvage
Enterococcus
Standard of Care
Reoperation
Tertiary Care Centers
Caregivers
Canada
Orthopedics
Staphylococcus aureus
Patient Care
Hypersensitivity
Randomized Controlled Trials
Quality of Life

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Ghert, M., Deheshi, B., Holt, G., Randall, R. L., Ferguson, P., Wunder, J., ... Bhandari, M. (2012). Prophylactic antibiotic regimens in tumour surgery (PARITY): Protocol for a multicentre randomised controlled study. BMJ open, 2(6), [e002197]. https://doi.org/10.1136/bmjopen-2012-002197
Ghert, Michelle ; Deheshi, Benjamin ; Holt, Ginger ; Randall, R. Lor ; Ferguson, Peter ; Wunder, Jay ; Turcotte, Robert ; Werier, Joel ; Clarkson, Paul ; Damron, Timothy ; Benevenia, Joseph ; Anderson, Megan ; Gebhardt, Mark ; Isler, Marc ; Mottard, Sophie ; Healey, John ; Evaniew, Nathan ; Racano, Antonella ; Sprague, Sheila ; Swinton, Marilyn ; Bryant, Dianne ; Thabane, Lehana ; Guyatt, Gordon ; Bhandari, Mohit. / Prophylactic antibiotic regimens in tumour surgery (PARITY) : Protocol for a multicentre randomised controlled study. In: BMJ open. 2012 ; Vol. 2, No. 6.
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abstract = "Introduction: Limb salvage with endoprosthetic reconstruction is the standard of care for the management of lower-extremity bone tumours in skeletally mature patients. The risk of deep postoperative infection in these procedures is high and the outcomes can be devastating. The most effective prophylactic antibiotic regimen remains unknown, and current clinical practice is highly varied. This trial will evaluate the effect of varying postoperative prophylactic antibiotic regimens on the incidence of deep infection following surgical excision and endoprosthetic reconstruction of lower-extremity bone tumours. Methods and analysis: This is a multicentre, blinded, randomised controlled trial, using a parallel two-arm design. 920 patients 15 years of age or older from 12 tertiary care centres across Canada and the USA who are undergoing surgical excision and endoprosthetic reconstruction of a primary bone tumour will receive either short (24 h) or long (5 days) duration postoperative antibiotics. Exclusion criteria include prior surgery or infection within the planned operative field, known colonisation with methicillinresistant Staphylococcus aureus or vancomycinresistant Enterococcus at enrolment, or allergy to the study antibiotics. The primary outcome will be rates of deep postoperative infections in each arm. Secondary outcomes will include type and frequency of antibioticrelated adverse events, patient functional outcomes and quality-of-life scores, reoperation and mortality. Randomisation will be blocked, with block sizes known only to the methods centre responsible for randomisation, and stratified by location of tumour and study centre. Patients, care givers and a Central Adjudication Committee will be blinded to treatment allocation. The analysis to compare groups will be performed using Cox regression and log-rank tests to compare survival functions at α=0.05. Ethics and dissemination: This study has ethics approval from the McMaster University/Hamilton Health Sciences Research Ethics Board (REB# 12-009). Successful completion will significantly impact on clinical practice and enhance patients' lives. More broadly, this trial will develop a network of collaboration from which further high-quality trials in Orthopaedic Oncology will follow.",
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Ghert, M, Deheshi, B, Holt, G, Randall, RL, Ferguson, P, Wunder, J, Turcotte, R, Werier, J, Clarkson, P, Damron, T, Benevenia, J, Anderson, M, Gebhardt, M, Isler, M, Mottard, S, Healey, J, Evaniew, N, Racano, A, Sprague, S, Swinton, M, Bryant, D, Thabane, L, Guyatt, G & Bhandari, M 2012, 'Prophylactic antibiotic regimens in tumour surgery (PARITY): Protocol for a multicentre randomised controlled study', BMJ open, vol. 2, no. 6, e002197. https://doi.org/10.1136/bmjopen-2012-002197

Prophylactic antibiotic regimens in tumour surgery (PARITY) : Protocol for a multicentre randomised controlled study. / Ghert, Michelle; Deheshi, Benjamin; Holt, Ginger; Randall, R. Lor; Ferguson, Peter; Wunder, Jay; Turcotte, Robert; Werier, Joel; Clarkson, Paul; Damron, Timothy; Benevenia, Joseph; Anderson, Megan; Gebhardt, Mark; Isler, Marc; Mottard, Sophie; Healey, John; Evaniew, Nathan; Racano, Antonella; Sprague, Sheila; Swinton, Marilyn; Bryant, Dianne; Thabane, Lehana; Guyatt, Gordon; Bhandari, Mohit.

In: BMJ open, Vol. 2, No. 6, e002197, 01.12.2012.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Prophylactic antibiotic regimens in tumour surgery (PARITY)

T2 - Protocol for a multicentre randomised controlled study

AU - Ghert, Michelle

AU - Deheshi, Benjamin

AU - Holt, Ginger

AU - Randall, R. Lor

AU - Ferguson, Peter

AU - Wunder, Jay

AU - Turcotte, Robert

AU - Werier, Joel

AU - Clarkson, Paul

AU - Damron, Timothy

AU - Benevenia, Joseph

AU - Anderson, Megan

AU - Gebhardt, Mark

AU - Isler, Marc

AU - Mottard, Sophie

AU - Healey, John

AU - Evaniew, Nathan

AU - Racano, Antonella

AU - Sprague, Sheila

AU - Swinton, Marilyn

AU - Bryant, Dianne

AU - Thabane, Lehana

AU - Guyatt, Gordon

AU - Bhandari, Mohit

PY - 2012/12/1

Y1 - 2012/12/1

N2 - Introduction: Limb salvage with endoprosthetic reconstruction is the standard of care for the management of lower-extremity bone tumours in skeletally mature patients. The risk of deep postoperative infection in these procedures is high and the outcomes can be devastating. The most effective prophylactic antibiotic regimen remains unknown, and current clinical practice is highly varied. This trial will evaluate the effect of varying postoperative prophylactic antibiotic regimens on the incidence of deep infection following surgical excision and endoprosthetic reconstruction of lower-extremity bone tumours. Methods and analysis: This is a multicentre, blinded, randomised controlled trial, using a parallel two-arm design. 920 patients 15 years of age or older from 12 tertiary care centres across Canada and the USA who are undergoing surgical excision and endoprosthetic reconstruction of a primary bone tumour will receive either short (24 h) or long (5 days) duration postoperative antibiotics. Exclusion criteria include prior surgery or infection within the planned operative field, known colonisation with methicillinresistant Staphylococcus aureus or vancomycinresistant Enterococcus at enrolment, or allergy to the study antibiotics. The primary outcome will be rates of deep postoperative infections in each arm. Secondary outcomes will include type and frequency of antibioticrelated adverse events, patient functional outcomes and quality-of-life scores, reoperation and mortality. Randomisation will be blocked, with block sizes known only to the methods centre responsible for randomisation, and stratified by location of tumour and study centre. Patients, care givers and a Central Adjudication Committee will be blinded to treatment allocation. The analysis to compare groups will be performed using Cox regression and log-rank tests to compare survival functions at α=0.05. Ethics and dissemination: This study has ethics approval from the McMaster University/Hamilton Health Sciences Research Ethics Board (REB# 12-009). Successful completion will significantly impact on clinical practice and enhance patients' lives. More broadly, this trial will develop a network of collaboration from which further high-quality trials in Orthopaedic Oncology will follow.

AB - Introduction: Limb salvage with endoprosthetic reconstruction is the standard of care for the management of lower-extremity bone tumours in skeletally mature patients. The risk of deep postoperative infection in these procedures is high and the outcomes can be devastating. The most effective prophylactic antibiotic regimen remains unknown, and current clinical practice is highly varied. This trial will evaluate the effect of varying postoperative prophylactic antibiotic regimens on the incidence of deep infection following surgical excision and endoprosthetic reconstruction of lower-extremity bone tumours. Methods and analysis: This is a multicentre, blinded, randomised controlled trial, using a parallel two-arm design. 920 patients 15 years of age or older from 12 tertiary care centres across Canada and the USA who are undergoing surgical excision and endoprosthetic reconstruction of a primary bone tumour will receive either short (24 h) or long (5 days) duration postoperative antibiotics. Exclusion criteria include prior surgery or infection within the planned operative field, known colonisation with methicillinresistant Staphylococcus aureus or vancomycinresistant Enterococcus at enrolment, or allergy to the study antibiotics. The primary outcome will be rates of deep postoperative infections in each arm. Secondary outcomes will include type and frequency of antibioticrelated adverse events, patient functional outcomes and quality-of-life scores, reoperation and mortality. Randomisation will be blocked, with block sizes known only to the methods centre responsible for randomisation, and stratified by location of tumour and study centre. Patients, care givers and a Central Adjudication Committee will be blinded to treatment allocation. The analysis to compare groups will be performed using Cox regression and log-rank tests to compare survival functions at α=0.05. Ethics and dissemination: This study has ethics approval from the McMaster University/Hamilton Health Sciences Research Ethics Board (REB# 12-009). Successful completion will significantly impact on clinical practice and enhance patients' lives. More broadly, this trial will develop a network of collaboration from which further high-quality trials in Orthopaedic Oncology will follow.

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U2 - https://doi.org/10.1136/bmjopen-2012-002197

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