Study Comparing SuperCable and Conventional Steel Wires for Sternum Closure After Heart Surgery.
Summary description of the study
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 under investigation
Sternum closure after performed bypass surgery.
(BASEC)
Disease under 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)
Exclusion criteria
1) Allergic reactions (known allergies, e.g., to nickel or titanium) 2) Pregnancy 3) Surgical history (previous sternotomy) (BASEC)
Trial sites
Zurich
(BASEC)
Sponsor
Sponsor Investigator & Principal Investigator: Héctor Rodríguez Cetina Biefer Tel: +41 44 416 45 25 Email: hector.rodriguez@usz.ch
(BASEC)
Contact
Contact Person Switzerland
Héctor Rodríguez Cetina Biefer
+41 44 416 45 25
hector.rodriguez@clutterusz.chUniversity Hospital Zurich Clinic for Cardiac Surgery Rämistrasse 100 8091 Zurich
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
19.08.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Prospective-randomized trial to demonstrate superiority of Super Cable vs. conventional steel wire for closure after a median sternotomy (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available