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Prophylactic antibiotic regimens in tumour surgery (PARITY): a pilot multicentre randomised controlled trial

OBJECTIVE: Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a five-d...

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Autor principal: Investigators, The PARITY
Formato: Online Artículo Texto
Lenguaje:English
Publicado: British Editorial Society of Bone and Joint Surgery 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4602191/
https://www.ncbi.nlm.nih.gov/pubmed/26423584
http://dx.doi.org/10.1302/2046-3758.49.2000482
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author Investigators, The PARITY
author_facet Investigators, The PARITY
author_sort Investigators, The PARITY
collection PubMed
description OBJECTIVE: Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a five-day regimen of post-operative antibiotics, in comparison to a 24-hour regimen, decreases surgical site infections in patients undergoing endoprosthetic reconstruction for lower extremity primary bone tumours. METHODS: We performed a pilot international multi-centre RCT. We used central randomisation to conceal treatment allocation and sham antibiotics to blind participants, surgeons, and data collectors. We determined feasibility by measuring patient enrolment, completeness of follow-up, and protocol deviations for the antibiotic regimens. RESULTS: We screened 96 patients and enrolled 60 participants (44 men and 16 women) across 21 sites from four countries over 24 months (mean 2.13 participants per site per year, standard deviation 2.14). One participant was lost to follow-up and one withdrew consent. Complete data were obtained for 98% of eligible patients at two weeks, 83% at six months, and 73% at one year (the remainder with partial data or pending queries). In total, 18 participants missed at least one dose of antibiotics or placebo post-operatively, but 93% of all post-operative doses were administered per protocol. CONCLUSIONS: It is feasible to conduct a definitive multi-centre RCT of post-operative antibiotic regimens in patients with bone sarcomas, but further expansion of our collaborative network will be critical. We have demonstrated an ability to coordinate in multiple countries, enrol participants, maintain protocol adherence, and minimise losses to follow-up. Cite this article: Bone Joint Res;4:154–162
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spelling pubmed-46021912015-11-04 Prophylactic antibiotic regimens in tumour surgery (PARITY): a pilot multicentre randomised controlled trial Investigators, The PARITY Bone Joint Res Oncology OBJECTIVE: Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a five-day regimen of post-operative antibiotics, in comparison to a 24-hour regimen, decreases surgical site infections in patients undergoing endoprosthetic reconstruction for lower extremity primary bone tumours. METHODS: We performed a pilot international multi-centre RCT. We used central randomisation to conceal treatment allocation and sham antibiotics to blind participants, surgeons, and data collectors. We determined feasibility by measuring patient enrolment, completeness of follow-up, and protocol deviations for the antibiotic regimens. RESULTS: We screened 96 patients and enrolled 60 participants (44 men and 16 women) across 21 sites from four countries over 24 months (mean 2.13 participants per site per year, standard deviation 2.14). One participant was lost to follow-up and one withdrew consent. Complete data were obtained for 98% of eligible patients at two weeks, 83% at six months, and 73% at one year (the remainder with partial data or pending queries). In total, 18 participants missed at least one dose of antibiotics or placebo post-operatively, but 93% of all post-operative doses were administered per protocol. CONCLUSIONS: It is feasible to conduct a definitive multi-centre RCT of post-operative antibiotic regimens in patients with bone sarcomas, but further expansion of our collaborative network will be critical. We have demonstrated an ability to coordinate in multiple countries, enrol participants, maintain protocol adherence, and minimise losses to follow-up. Cite this article: Bone Joint Res;4:154–162 British Editorial Society of Bone and Joint Surgery 2015-09-01 /pmc/articles/PMC4602191/ /pubmed/26423584 http://dx.doi.org/10.1302/2046-3758.49.2000482 Text en ©2015 The Parity Investigators ©2015 The Parity Investigators. This is an open-access article distributed under the terms of the Creative Commons Attributions licence, which permits unrestricted use, distribution, and reproduction in any medium, but not for commercial gain, provided the original author and source are credited.
spellingShingle Oncology
Investigators, The PARITY
Prophylactic antibiotic regimens in tumour surgery (PARITY): a pilot multicentre randomised controlled trial
title Prophylactic antibiotic regimens in tumour surgery (PARITY): a pilot multicentre randomised controlled trial
title_full Prophylactic antibiotic regimens in tumour surgery (PARITY): a pilot multicentre randomised controlled trial
title_fullStr Prophylactic antibiotic regimens in tumour surgery (PARITY): a pilot multicentre randomised controlled trial
title_full_unstemmed Prophylactic antibiotic regimens in tumour surgery (PARITY): a pilot multicentre randomised controlled trial
title_short Prophylactic antibiotic regimens in tumour surgery (PARITY): a pilot multicentre randomised controlled trial
title_sort prophylactic antibiotic regimens in tumour surgery (parity): a pilot multicentre randomised controlled trial
topic Oncology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4602191/
https://www.ncbi.nlm.nih.gov/pubmed/26423584
http://dx.doi.org/10.1302/2046-3758.49.2000482
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