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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Soft Tissue Injuries; Substance Dependence; Foreign Bodies; Drug Abuse, Intravenous; Needle Injury
• Intervention / Treatment: Radiation: Low-dose X-ray of subcutaneous tissues

Detailed Description

The clinical significance of retained needle fragments remains unknown. Needle retentions can be asymptomatic, cause local symptoms, and can sometimes even lead to dangerous complications such as needle emboli to the heart or lungs. The most common injection sites are likely the peripheral veins of the arms. However, continuous IVD use leads to vein sclerosis, and patients with long-term use may therefore also use peripheral veins of their lower limbs and even the central veins of the groin or neck. Subcutaneously retained needles can pose a risk of needlestick injury to medical staff during clinical examination and treatment procedures. Unrecognized retained needles can also cause hazards during magnetic resonance imaging.

The study protocol received a positive review from the Tampere University Hospital Ethics Committee (study code: R22037). The researchers subsequently received the organizational permissions necessary to conduct the study. PWIDs will be asked to give written informed consent prior to any study procedures. Participants will be asked to fill in a questionnaire about their basic information, drug use history, previous injection sites, and whether they have had any local complications due to injecting drugs. After the completion of the questionnaire, participants will undergo targeted X-ray imaging of the injection sites. As metallic objects, needle fragments can be visualized with standard X-ray imaging. Female participants of childbearing potential (< 50 years) will undergo urine sample pregnancy testing prior to X-ray imaging. A pilot study with 20 participants will be conducted first. Experiences from the pilot will be used to refine the study protocol if needed. If modifications are made, they will be subjected to ethics review and will be provided on ClinicalTrials.gov. After the pilot study, the researchers aim to recruit an additional 80 patients (totaling up to 100 participants).

Our research questions are 1) What is the prevalence of radiologically confirmed needle retention among PWIDs*? The secondary research questions are

1. Do patient-reported symptoms and the suspicion of a retained needle fragments correspond to radiologically confirmed needle retention?
2. What are the predisposing factors to needle fragmentation?
3. Have PWIDs sought medical attention prior to the study for possible symptoms in the injection sites?
4. How frequently are verified needle fragments surgically removed within five years after their detection, and are verified needle fragments a proxy or a risk factor for mortality? *As only patients in outpatient care will be recruited, the sample is not entirely representative of all PWIDs in the study area (e.g., people who are hospitalized or imprisoned are not recruited).

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Otso Arponen, Associate Professor, MD; Phone Number: +358 50 410 6170; Email: otso.arponen@tuni.fi

Study Locations

• Finland
  • Tampere, Finland
    • Recruiting
    • Hatanpää Health Center
    • Contact: Phone Number: 040 8063649

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Deaconess Foundation; A-Clinic Foundation
• Investigators: Study Chair: 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; Principal Investigator: Markku Sumanen, MD-PhD, Tampere University

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2023
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 15, 2028

Study Registration Dates

• First Submitted: October 22, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Intravenous drug use; needle retention; needle fragment
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Substance Abuse, Intravenous; Wounds and Injuries; Soft Tissue Injuries; Foreign Bodies
• Other Study ID Numbers: Retained drug needles

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans to share individual-level data with other investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No