Neodymium Magnet-Guided Removal of Metallic Soft Tissue Foreign Bodies in the Emergency Department
Efficacy and Safety of Neodymium Magnet-Guided Removal of Metallic Foreign Bodies in Soft Tissue in the Emergency Department
The goal of this clinical trial is to learn if a strong magnet (neodymium magnet) can help doctors remove metal objects stuck under the skin in adults. It will also learn about the safety of this method. The main questions it aims to answer are:
- How often can doctors remove the metal object with the help of the magnet?
- How long does the procedure take?
- How often do doctors need to make a cut in the skin, and how long is the cut?
- What problems do participants have within 15 days after the procedure?
- How satisfied are participants with the procedure?
Participants will:
- Have an X-ray to find the metal object
- Have the metal object removed with the help of the magnet in the emergency department, with or without numbing medicine (local anesthetic)
- Come back for a wound check 15 days after the procedure
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This prospective, single-center, single-arm study is conducted in the Emergency Department of Bursa Uludag University Faculty of Medicine Hospital. Before the procedure, the location of the foreign body and its distance from the skin surface are measured on X-ray, and the entry site is photographed. Before sterile preparation, the magnetic property of the foreign body is confirmed with the neodymium magnet. After sterile preparation, the foreign body is localized with a sterile-draped neodymium magnet. Local anesthesia is applied if needed. The foreign body is removed through the existing wound or, if there is none, through a skin incision. The site is photographed again after removal. Prophylactic antibiotics are given for contaminated wounds. Participants are re-evaluated at suture removal or 15 days after the procedure.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Ziya Uzun, MD
- Telefonnummer: +90 538 737 96 52
- E-Mail: ziyauzun@uludag.edu.tr
Studienorte
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Bursa
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Bursa, Bursa, Türkei (türkiye), 16059
- Rekrutierung
- Bursa Uludag University Faculty of Medicine Hospital, Emergency Department
-
Kontakt:
- Ziya Uzun, MD
- Telefonnummer: +90 538 737 96 52
- E-Mail: ziyauzun@uludag.edu.tr
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Age 18 years or older
- Metallic foreign body in the soft tissue detected on plain radiography
- Foreign body located less than 2 cm from the skin surface
- Foreign body with magnetic properties that interacts with the magnet
- Signed written informed consent
Exclusion Criteria:
- Age under 18 years
- Foreign body located close to structures such as blood vessels, nerves or joint spaces
- Deep location requiring surgical removal
- Inability to cooperate
- Bleeding or coagulation disorder
- Refusal to sign informed consent
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Neodymium Magnet-Guided Removal
Adults with a magnetic metallic foreign body in the soft tissue. The foreign body is removed with the help of a neodymium magnet in the emergency department, with or without local anesthesia. |
After sterile preparation, the foreign body is localized and pulled toward the skin surface with a sterile-draped neodymium (NdFeB) magnet, and removed through the existing wound or a skin incision.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Successful removal of the foreign body
Zeitfenster: During the procedure (Day 0)
|
Number and percentage of foreign bodies successfully removed with the help of the neodymium magnet. |
During the procedure (Day 0)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Complete removal per participant
Zeitfenster: During the procedure (Day 0)
|
Number and percentage of participants in whom all foreign bodies were successfully removed. |
During the procedure (Day 0)
|
|
Procedure time
Zeitfenster: During the procedure (Day 0)
|
Duration of the foreign body removal procedure, in minutes. |
During the procedure (Day 0)
|
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Need for additional incision and its length
Zeitfenster: During the procedure (Day 0)
|
Number and percentage of participants who need a new or additional skin incision, and the length of the incision in millimeters, if required. |
During the procedure (Day 0)
|
|
Volume of local anesthetic
Zeitfenster: During the procedure (Day 0)
|
Volume of local anesthetic used during the procedure, in milliliters, in participants who receive local anesthesia. |
During the procedure (Day 0)
|
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Complications
Zeitfenster: 15 days after the procedure
|
Number and percentage of participants with complications (such as wound infection or bleeding) within 15 days after the procedure. |
15 days after the procedure
|
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Patient satisfaction
Zeitfenster: Immediately after the procedure (Day 0)
|
Participant satisfaction with the procedure on a 5-point Likert scale (1 = not satisfied at all, 5 = very satisfied). Higher scores mean greater satisfaction. |
Immediately after the procedure (Day 0)
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Ziya Uzun, MD, Uludag University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Shvediuk VV, Elin NE, Dzidzava II, Fufayev EE, Barinov OV. Clinical application of neodymium magnetic instruments for the removal of foreign bodies in blind wounds. Russian Military Medical Academy Reports. 2023;42(2):105-114. doi: 10.17816/rmmar346674.
- Sarihan A, Can C. Soft tissue foreign body removal with magnet in ED settings. Am J Emerg Med. 2014 Aug;32(8):952.e3-5. doi: 10.1016/j.ajem.2014.02.009. Epub 2014 Feb 17. No abstract available.
- Radia R, Suffern R, Pepper T, Fan K. A blacksmith's tale: use of a rare earth magnet to facilitate safe removal of a metallic fragment from the face. Br J Oral Maxillofac Surg. 2020 Dec;58(10):e317-e319. doi: 10.1016/j.bjoms.2020.07.029. Epub 2020 Jul 26.
- Lukish JT, Williams K, Shah A, Mon R, Lukish JR. The Novel Use of Rare Earth Magnets for the Extraction of Metallic Soft Tissue Foreign Bodies in Children. Surg Innov. 2023 Oct;30(5):571-575. doi: 10.1177/15533506231158209. Epub 2023 Mar 14.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2025-21/14
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Individual participant data will not be shared because the informed consent form and ethics approval do not cover sharing of individual-level data with third parties. Aggregated results will be published.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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