Prevalence and predisposing factors of retained drug needle fragments in people who inject drugs: a protocol for a preliminary cross-sectional multicentre observational study in Finland.

introductionNumerous published case reports have described retained drug needle fragments in soft tissue as causes of localised pain and infections in persons who inject drugs (PWIDs). Furthermore, there are case reports of PWIDs with lung and heart embolisations caused by needle emboli. Subcutaneously retained needles also pose a risk of needlestick injury to medical staff. There are no previous epidemiological attempts to evaluate how common X-ray-confirmed retained drug needle fragments are among community-dwelling PWIDs. Due to the unclear clinical relevance of needle fragment retentions, there is a need to systematically evaluate the prevalence of retained needles, related complications and risk factors predisposing needle fragmentations. METHODS AND ANALYSIS: We have planned a prospective cross-sectional study covering multiple ambulatory clinics that manage PWIDs in Tampere, Finland. PWIDs will be asked to give their written informed consent prior to any study procedures. Initially, we aim to recruit a sample for a pilot study of 20 adults (≥18 years) who will be asked to fill out a questionnaire related to their drug use history and their suspicions of having retained needle fragments. Subsequently, participants will undergo X-ray imaging of the injection sites as part of the study. Female participants of childbearing age (<50 years) will undergo urine sample pregnancy testing prior to X-ray imaging. If a needle fragment is found, the participant will be referred to a tertiary centre for consultation at their individual discretion. After the pilot study, we aim to recruit 80 more adult participants. ETHICS AND DISSEMINATION: We submitted the study protocol for ethics review to the Tampere University Hospital Ethics Committee and received their favourable opinion (study code: R22037). We subsequently sought organisational permission from the clinics to conduct the study. To be enrolled, PWIDs must provide written informed consent. The study results will be published in international peer-reviewed journals and conference proceedings. TRIAL REGISTRATION NUMBER: NCT05679284.