Observational study on retained needle fragments in intravenous drug users
The Prevalence and Predisposing Factors to Retained Drug Needle Fragments in People Who Inject Drugs: a Protocol for a Cross-sectional Observational Study
This study is trying to find out how common it is for people who use intravenous drugs to have leftover pieces of needles in their bodies and what factors might increase this risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tampere University Hospital Academic / other |
| Locations | 1 site (Tampere) |
| Trial ID | NCT05679284 on ClinicalTrials.gov |
What this trial studies
This study aims to estimate the prevalence of retained needle fragments in people who use intravenous drugs (PWIDs) and identify associated risk factors. Participants will complete a questionnaire regarding their drug use history and injection practices, followed by targeted low-dose X-ray imaging of their injection sites to detect any retained needle fragments. The study seeks to understand the local tissue complications and potential hazards posed by these fragments, which can lead to serious health issues. The research has received ethical approval and aims to provide valuable insights into a largely unstudied aspect of intravenous drug use.
Who should consider this trial
Good fit: Ideal candidates are individuals with a history of intravenous drug use who are currently receiving treatment for their substance dependence.
Not a fit: Patients who have never used intravenous drugs or those who are underage or pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of the risks associated with intravenous drug use and inform better clinical practices for managing complications.
How similar studies have performed: While there have been case reports on retained needle fragments, this study represents a novel approach to systematically assess the prevalence and risks associated with this condition.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * History of intravenous drug use * Current treatment of the drug abuse problem at a local low-threshold drug abuse service unit or primary health care centre. * Adherence to fill in the questionnaire * Participation to X-ray imaging of injection sites Exclusion Criteria: * No history of intravenous drug use * Does not adhere to fill in the questionnaire or refuses X-ray imaging * Pregnancy * Underage (18 years old)
Where this trial is running
Tampere
- Hatanpää Health Center — Tampere, Finland (Recruiting)
Study contacts
- Principal investigator: Markku Sumanen, MD-PhD — Tampere University
- Study coordinator: Otso Arponen, Associate Professor, MD
- Email: otso.arponen@tuni.fi
- Phone: +358 50 410 6170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.