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

@entity1 @entity79 @entity5
OBJECTIVE: Clinical studies of @entity1 with @entity79 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 @entity1 undergoing endoprosthetic reconstruction for lower extremity primary @entity5 . METHODS: We performed a pilot international multi-centre RCT. We used central randomisation to conceal treatment allocation and sham antibiotics to blind @entity1 , surgeons, and data collectors. We determined feasibility by measuring @entity1 enrolment, completeness of follow-up, and protocol deviations for the antibiotic regimens. RESULTS: We screened 96 @entity1 and enrolled 60 @entity1 (44 @entity1 and 16 @entity1 ) across 21 sites from four countries over 24 months (mean 2.13 @entity1 per site per year, standard deviation 2.14). One @entity1 was lost to follow-up and one withdrew consent. Complete data were obtained for 98% of eligible @entity1 at two weeks, 83% at six months, and 73% at one year (the remainder with partial data or pending queries). In total, 18 @entity1 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 @entity1 with @entity79 , but further expansion of our collaborative network will be critical. We have demonstrated an ability to coordinate in multiple countries, enrol @entity1 , maintain protocol adherence, and minimise losses to follow-up. Cite this article: Bone Joint Res;4:154-162.
