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
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Ziya Uzun, MD
- Numer telefonu: +90 538 737 96 52
- E-mail: ziyauzun@uludag.edu.tr
Lokalizacje studiów
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-
Bursa
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Bursa, Bursa, Turcja (Türkiye), 16059
- Rekrutacyjny
- Bursa Uludag University Faculty of Medicine Hospital, Emergency Department
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Kontakt:
- Ziya Uzun, MD
- Numer telefonu: +90 538 737 96 52
- E-mail: ziyauzun@uludag.edu.tr
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Successful removal of the foreign body
Ramy czasowe: 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)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Complete removal per participant
Ramy czasowe: During the procedure (Day 0)
|
Number and percentage of participants in whom all foreign bodies were successfully removed. |
During the procedure (Day 0)
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|
Procedure time
Ramy czasowe: 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
Ramy czasowe: 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)
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|
Volume of local anesthetic
Ramy czasowe: 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
Ramy czasowe: 15 days after the procedure
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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
Ramy czasowe: 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)
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Ziya Uzun, MD, Uludag University
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2025-21/14
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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