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

NCT05679284 | Recruiting

• 1 other identifier: Retained drug needles
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Drug Abuse, Intravenous; Substance Dependence; Needle Injury; Soft Tissue Injuries; Foreign Bodies

Keywords

Intravenous drug use; needle retention; needle fragment

Outcome Measures

Primary Outcomes (3)

• 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.

  An average of 2 years.

• 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.

  An average of 2 years.

• 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.

  Up to 5 years.

Study Arms (2)

Cases: Intravenous drug users with drug needle fragment retentions

All intravenous drug users from the service units will be asked to participate. X-ray imaging has the goal to identify patients with needle fragment retentions in subcutaneous tissue.

Radiation: Low-dose X-ray of subcutaneous tissues

Controls: Intravenous drug users without drug needle fragment retentions

All intravenous drug users from the service units will be asked to participate. Control group consists of those with no radiologically confirmed subcutaneous needle fragment retentions.

Radiation: Low-dose X-ray of subcutaneous tissues

Interventions

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.

Cases: Intravenous drug users with drug needle fragment retentions; Controls: Intravenous drug users without drug needle fragment retentions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population base is the adult IVD users from the drug abuse treatment centres in Tampere, Finland.

You may qualify if:

• 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

You may not qualify if:

• No history of intravenous drug use
• Does not adhere to fill in the questionnaire or refuses X-ray imaging
• Pregnancy
• Underage (18 years old)

Sponsors & Collaborators

• Tampere University Hospital: lead
• Deaconess Foundation: collaborator
• A-Clinic Foundation: collaborator

Study Sites (1)

Hatanpää Health Center

Tampere, Finland

RECRUITING

Related Publications (1)

• Laukkala H, Arponen O, Rinta-Kiikka I, Sumanen M, Nevalainen OPO. 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. BMJ Open. 2025 Aug 10;15(8):e099521. doi: 10.1136/bmjopen-2025-099521.

  PMID: 40784774 DERIVED

MeSH Terms

Conditions

Substance Abuse, Intravenous; Substance-Related Disorders; Soft Tissue Injuries; Foreign Bodies

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Wounds and Injuries

Study Officials

• Otso Arponen, MD-PhD

  Pirkanmaa Hospital District (PSHP)

  STUDY CHAIR

• Olli PO Nevalainen, MD-PhD

  City of Tampere; Tampere University; Pirkanmaa Hospital District (PSHP).

  STUDY CHAIR

• Irina Rinta-Kiikka, MD-PhD

  Tampere University Hospital

  STUDY CHAIR

• Heidi Laukkala, MD

  City of Tampere, Tampere University

  STUDY CHAIR

• Markku Sumanen, MD-PhD

  Tampere University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Otso Arponen, Associate Professor, MD

CONTACT

+358 50 410 6170; otso.arponen@tuni.fi

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2022
• First Posted: January 10, 2023
• Study Start: May 25, 2023
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 15, 2028
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)