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Author Notes:

Center for Evidence-Based Orthopaedics, McMaster University , 293 Wellington Street North, Suite 110, Hamilton, ON L8L 8E7, Canada. Correspondence should be sent to Dr M. Ghert; e-mail: mghert@hhsc.ca

For a full list of contributors, see full article

This study was coordinated by the Center for Evidence-Based Orthopaedics at McMaster University

Conflict of Interest: None declared

Subjects:

Research Funding:

This work was supported by grants from Physicians’ Services Incorporated, Orthopaedic Research and Education Fund/Musculoskeletal Tumor Society, and Canadian Cancer Society Research Institute

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Cell & Tissue Engineering
  • Orthopedics
  • Cell Biology
  • Orthopaedic oncology
  • bone sarcoma
  • randomised controlled trials
  • antibiotics
  • pilot study
  • LIMB-SALVAGE SURGERY
  • QUALITY-OF-LIFE
  • INFECTION
  • OSTEOSARCOMA
  • AMPUTATION
  • REPLACEMENT
  • RISK

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

Tools:

Journal Title:

Bone and Joint Research

Volume:

Volume 4, Number 9

Publisher:

, Pages 154-162

Type of Work:

Article | Final Publisher PDF

Abstract:

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 postoperative 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.

Copyright information:

©2015 The Parity Investigators

This is an Open Access work distributed under the terms of the Creative Commons Attribution 3.0 Unported License (http://creativecommons.org/licenses/by/3.0/).

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