Prophylactic antibiotic regimens in tumour surgery (PARITY): A pilot multicenter randomized controlled trial Journal Article

Author: The PARITY Investigators
Contributors: Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.
Article Title: Prophylactic antibiotic regimens in tumour surgery (PARITY): A pilot multicenter randomized controlled trial
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.
Keywords: osteosarcoma; infection; risk; pilot study; amputation; quality-of-life; limb-salvage surgery; replacement; antibiotics; bone sarcoma; orthopaedic oncology; randomised controlled trials
Journal Title: Bone & Joint Research
Volume: 4
Issue: 9
ISSN: 2046-3758
Publisher: British Editorial Society of Bone and Joint Surgery  
Date Published: 2015-09-01
Start Page: 154
End Page: 162
Language: English
ACCESSION: WOS:000364596500002
DOI: 10.1302/2046-3758.49.2000482
PMCID: PMC4602191
PUBMED: 26423584
Notes: Article -- Source: Wos
Citation Impact
MSK Authors
  1. John H Healey
    440 Healey
  2. Jesse   Galle
    5 Galle
  3. Sarina   Lopez
    1 Lopez