This page is for an ongoing trial. Please do not use unless you are part of the trial.
This trial will measure the effect of “Intra-pocket Vancomycin During INS Replacement Therapy” or “IV-DIRT”
Ethical approval has been granted by the University of British Columbia (UBC) Clinical Research Ethics Board (certificate # H16-01496) and the trial is registered with clinicaltrials.gov (Identifier ?)
This trial is a prospective, randomized, multi-centre study measuring the infection rate following INS replacement with and without intra-pocket Vancomycin. Demographic data will be collected prospectively for patients undergoing elective INS replacement. Patients who consent to participate will be randomized to receive intra-pocket Vancomycin (1g in 5ml) or saline (5ml). Outcome is defined as a wound infection requiring removal of the INS before 6 months. The power calculation has been set to detect a 2% difference in rate (i.e. 3% versus 1%) with a confidence level of 95% and a power of 90%. The total sample size will be 1025 patients. Each arm of the study (Vancomycin or saline) will have 512 patients. Demographic data will be collected to ensure each arm of the study had similar characteristics including well known risk factors for infection (e.g. diabetes, age, body mass index, number of replacements). All data will be entered into a secure REDCAP site for analysis by the Vancouver team.
We will help with your institutions ethics board application.
The REDCAP site to enter data is https://redcap.mobilityandhealth.ca/redcap/surveys/?s=MH4KAAMJNE