About this trial
During certain heart surgeries, the sternum is opened and must then be closed securely. The study compares two closure methods - steel wires and SuperCable - in terms of stability, healing, and patient satisfaction. This investigation aims to demonstrate that the iso-elastic properties of the SuperCable Sternal Closure System result in faster sternal bone healing, reduced postoperative pain, shorter hospital stay, and improved physical recovery compared to conventional steel wire sternal closure. Eighty-six patients are participating and are randomly assigned to one of the two groups. After the operation, pain, healing, and possible complications are checked. The patients are examined 3 and 6 months after the operation.
Eligibility criteria
Qualifiers
Provision of Informed Consent: The subject must have signed and dated the informed consent form prior to any study-related procedures.
Willingness and Ability to Comply: The subject must express a stated willingness to comply with all study procedures and be available for the duration of the study.
Age: The subject must be at least 18 years old.
Sex: Both male and female subjects are eligible. In line with the "Sex and Gender in Research Involving Humans" recommendations, data will be stratified and analyzed by sex to identify any potential differences in outcomes.
Disqualifiers
Pharmacological Restrictions: Current use of corticosteroids or any immunosuppressive medication
Prior Treatments and Therapies: History of radiation therapy to the thorax
Pregnancy, or the intent to become pregnant during the study period
Lactation or current breastfeeding
Trial design
Treatments tested in this trial
- SuperCable®
- Steel Wires