SuperCable vs. Conventional Steel Wire for Closure After a Median Sternotomy

ConditionSternotomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Zurich

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

Treatment groups

86 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators