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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ziya Uzun, MD
- Numéro de téléphone: +90 538 737 96 52
- E-mail: ziyauzun@uludag.edu.tr
Lieux d'étude
-
-
Bursa
-
Bursa, Bursa, Turquie (Türkiye), 16059
- Recrutement
- Bursa Uludag University Faculty of Medicine Hospital, Emergency Department
-
Contact:
- Ziya Uzun, MD
- Numéro de téléphone: +90 538 737 96 52
- E-mail: ziyauzun@uludag.edu.tr
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Successful removal of the foreign body
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Complete removal per participant
Délai: 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
Délai: During the procedure (Day 0)
|
Duration of the foreign body removal procedure, in minutes. |
During the procedure (Day 0)
|
|
Need for additional incision and its length
Délai: 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
Délai: 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)
|
|
Complications
Délai: 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
|
|
Patient satisfaction
Délai: 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)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ziya Uzun, MD, Uludag University
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025-21/14
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .