Study Comparing SuperCable and Conventional Steel Wires for Sternum Closure After Heart Surgery.
Descrizione riassuntiva dello studio
During heart surgery, the sternum is opened and must be securely closed afterward. This is typically done with steel wires, but a new system, SuperCable, could improve healing. The study compares these two methods in terms of stability, healing, and patient satisfaction. 86 patients are participating and are randomly assigned to one of the two groups – like flipping a coin. Neither the patients nor the doctors who will later care for them know which method was used. After the surgery, pain, healing, and possible complications are assessed. Patients will be examined 3 and 6 months after the surgery. All side effects will be documented, and serious events reported. The study follows strict ethical guidelines and has been approved. The results will be published to determine the best method for patients.
(BASEC)
Intervento studiato
Sternum closure after performed bypass surgery.
(BASEC)
Malattie studiate
The study focuses on the closure of the sternum after heart surgery. The patients examined have coronary artery disease that necessitates a bypass surgery via median sternotomy. At the end of the procedure, the severed sternum is either fixed with conventional steel wires or with the medical product SuperCable.
(BASEC)
1) The patient is undergoing an isolated CABG surgery (bypass procedure). 2) The participant is at least 18 years old and willing and able to comply with the study requirements. 3) Language proficiency: The participant has sufficient German language skills to independently and accurately complete the postoperative questionnaire. (BASEC)
Criteri di esclusione
1) Allergic reactions (known allergies, e.g., to nickel or titanium) 2) Pregnancy 3) Surgical history (previous sternotomy) (BASEC)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
Sponsor Investigator & Principal Investigator: Héctor Rodríguez Cetina Biefer Tel: +41 44 416 45 25 Email: hector.rodriguez@usz.ch
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Héctor Rodríguez Cetina Biefer
+41 44 416 45 25
hector.rodriguez@clutterusz.chUniversity Hospital Zurich Clinic for Cardiac Surgery Rämistrasse 100 8091 Zurich
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
19.08.2025
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
Prospective-randomized trial to demonstrate superiority of Super Cable vs. conventional steel wire for closure after a median sternotomy (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
non disponibile
Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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non disponibile
Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
non disponibile
Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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