A Cross-Sectional Observational Study on Retained Drug Needle Fragments in People Who Use Intravenous Drugs

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTampere University Hospital

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Low-dose X-ray of subcutaneous tissues

    Radiation

    To 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

100 Participants
are divided into 2 treatment groups
Group A: Cases: Intravenous drug users with drug needle fragment retentions1 intervention
Group B: Controls: Intravenous drug users without drug needle fragment retentions1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
An average of 2 years.
2

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.

Time frame
An average of 2 years.
3

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.

Time frame
Up to 5 years.

Secondary outcomes

Other outcomes

Sponsors and contacts

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Tampere University Hospital

Lead sponsor

Deaconess Foundation

Collaborator

A-Clinic Foundation

Collaborator