About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
No history of intravenous drug use
Does not adhere to fill in the questionnaire or refuses X-ray imaging
Pregnancy
Underage (18 years old)
Trial population
The population base is the adult IVD users from the drug abuse treatment centres in Tampere, Finland.
Trial design
Case-control
Prospective
Treatments tested in this trial
Low-dose X-ray of subcutaneous tissues
RadiationTo identify needle fragment retentions, the radiologic imaging of all volunteers will be performed with X-ray using radiation doses as low as reasonably achievable (ALARA) and one projection per anatomic site.
Treatment groups
Trial outcomes
Primary outcomes
Prevalence of needle fragment retentions among intravenous drug users.
The prevalence of needle fragment retentions among intravenous drug users. The number of individuals with at least one radiologically confirmed needle fragment in subcutaneous tissue over the total number of participants.
Risk factors for needle fragment retentions in a cross-sectional design
Risk factors for needle fragment retentions in a cross-sectional design. Patient characteristics as risk factors for having subcutaneous needle fragment retentions.
The proportion of patients with surgically removed needle fragment retentions at five years of follow-up.
The proportion of patients with surgically removed needle fragment retentions after five years of follow-up. Patients with needle fragment retentions will be referred to the surgical clinic and will be prospectively followed up through healthcare records.
Sponsors and contacts
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Tampere University Hospital
Lead sponsor
Deaconess Foundation
Collaborator
A-Clinic Foundation
Collaborator