Actively Recruiting

Age: 18Years +
All Genders
ID05679284

The Prevalence and Predisposing Factors to Retained Drug Needle Fragments in People Who Inject Drugs: a Protocol for a Cross-sectional Observational Study

Led by Tampere University Hospital · Updated on 2023-06-01

100

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

T

Tampere University Hospital

Lead Sponsor

D

Deaconess Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying people who use intravenous drugs (PWIDs) to understand how often needle fragments remain in the body after injecting drugs and what factors contribute to this condition. Retained needle fragments can cause local pain, infections, or serious complications like needle emboli to the heart or lungs. The study aims to be the first large investigation into the frequency and risks of needle fragment retention among PWIDs, focusing on those receiving outpatient care at drug abuse service units. Participants will complete a questionnaire covering their drug use history, injection sites, and any related local symptoms. They will then undergo targeted low-dose X-ray imaging of common injection areas to detect retained needle fragments. Female participants under 50 will have a pregnancy test before imaging. The study includes an initial pilot with 20 participants to refine procedures, followed by recruitment of up to 100 total participants. During the study, researchers will collect information through questionnaires and X-ray imaging to identify needle fragment retention and related risk factors. They will also track how many participants have fragments surgically removed within five years after detection. The study involves outpatient volunteers who are currently in treatment and will last up to five years for follow-up of surgical outcomes and mortality risks associated with retained fragments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • History of intravenous drug use
  • Currently receiving treatment for drug abuse at a local low-threshold service unit or primary health care centre
  • Willingness to complete the questionnaire
  • Willingness to participate in X-ray imaging of injection sites
Not Eligible

You will not qualify if you...

  • No history of intravenous drug use
  • Unwillingness to complete the questionnaire or refusal of X-ray imaging
  • Pregnancy
  • Under 18 years old

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single visit

Participants complete a questionnaire about their drug use and injection history, and undergo targeted low-dose X-ray imaging of injection sites to identify retained needle fragments. Female participants of childbearing potential will have urine pregnancy testing prior to imaging.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Researchers observe participants for up to five years to assess the occurrence of surgical removal of needle fragments and related health outcomes.

Follow-up contacts as needed over 5 years

Trial Site Locations

Total: 1 location

1

Hatanpää Health Center

Tampere, Finland

Actively Recruiting

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Research Team

O

Otso Arponen, Associate Professor, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

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.

Heidi Laukkala, Otso Arponen, Irina Rinta-Kiikka...

https://pubmed.ncbi.nlm.nih.gov/40784774