Prophylactic antibiotic regimens in tumour surgery (PARITY)

Abstract

ObjectiveClinical 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. MethodsWe 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. ResultsWe 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. ConclusionsIt 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

Is there consensus regarding surgical treatment of bone sarcomas?

“…Local variations in factors such as bacterial or fugal prevalence, e.g ., Methicillin-resistant Staphylococcus aureus , Mycobacteria or Candida . Lack of consensus with regard to choice of implant (some manufactures provide silver or gentamycin coating) complicates the study[ 16 ]. Furthermore, cefazolin is not standard practice or available in all countries leading to a reduced number of potential participating centers.…”

The Surveillance After Extremity Tumor Surgery (SAFETY) trial: protocol for a pilot study to determine the feasibility of a multi-centre randomised controlled trial

“…Protocol adherence measure: During the pilot study of the PARITY trial, we were able to maintain an overall protocol adherence rate in excess of 90% 27. Recent reports prepared for the PARITY Data and Safety Monitoring Board (DSMB) indicate a similar protocol adherence rate.…”

“…Maintenance of data quality measure: We obtained a data completeness rate of approximately 90% in the PARITY trial pilot study 27. Therefore, we will consider our data quality strategies feasible if we are able to maintain 95% or greater completeness of participant follow-up data for the definitive primary outcome.…”

Moving forward through consensus: protocol for a modified Delphi approach to determine the top research priorities in the field of orthopaedic oncology

“… 7 The PARITY trial has the potential to significantly impact clinical practice well beyond its primary research objective because it is leading to the development of an international network of committed collaborators. 8 Properly leveraged, this promising collaborative group could facilitate additional high-quality RCTs in the field.…”