Study Comparing SuperCable and Conventional Steel Wires for Sternum Closure After Heart Surgery.
Résumé de l'étude
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)
Intervention étudiée
Sternum closure after performed bypass surgery.
(BASEC)
Maladie en cours d'investigation
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)
Critères d'exclusion
1) Allergic reactions (known allergies, e.g., to nickel or titanium) 2) Pregnancy 3) Surgical history (previous sternotomy) (BASEC)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
Sponsor Investigator & Principal Investigator: Héctor Rodríguez Cetina Biefer Tel: +41 44 416 45 25 Email: hector.rodriguez@usz.ch
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Héctor Rodríguez Cetina Biefer
+41 44 416 45 25
hector.rodriguez@clutterusz.chUniversity Hospital Zurich Clinic for Cardiac Surgery Rämistrasse 100 8091 Zurich
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
19.08.2025
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
Prospective-randomized trial to demonstrate superiority of Super Cable vs. conventional steel wire for closure after a median sternotomy (BASEC)
Titre académique
non disponible
Titre public
non disponible
Maladie en cours d'investigation
non disponible
Intervention étudiée
non disponible
Type d'essai
non disponible
Plan de l'étude
non disponible
Critères d'inclusion/exclusion
non disponible
non disponible
Critères d'évaluation principaux et secondaires
non disponible
non disponible
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
non disponible
ID secondaires
non disponible
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
non disponible
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible