A Cross-Sectional Observational Study on Retained Drug Needle Fragments in People Who Use Intrave… (NCT05679284) | Clinical Trial Compass
RecruitingNot Applicable
A Cross-Sectional Observational Study on Retained Drug Needle Fragments in People Who Use Intravenous Drugs
Finland100 participantsStarted 2023-05-25
Plain-language summary
In addition to the well-known toxicological harms of intravenous drug (IVD) use, there can also be local tissue complications, including infections, venous sclerosis, tissue necrosis, and drug needle fragment retentions. Drug needle fragments in subcutaneous tissue may cause local symptoms (usually pain and infections), but they have also been identified as causing emboli to organs. The literature has described numerous case reports of people who inject drugs (PWIDs) and have retained needle fragments. The prevalence of the condition is not known, and the researchers therefore aim to perform the first cross-sectional study of PWIDs to estimate how common needle fragment retentions are and what their risk factors are in this population.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of needle fragment retentions among intravenous drug users.
Timeframe: An average of 2 years.
2
Risk factors for needle fragment retentions in a cross-sectional design
Timeframe: An average of 2 years.
3
The proportion of patients with surgically removed needle fragment retentions at five years of follow-up.