SternotomySURENCT07251881
SuperCable vs. Conventional Steel Wire for Closure After a Median Sternotomy
A study testing SuperCable® and Steel Wires in people with Sternotomy, run by University of Zurich at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sternotomy
- What is being tested?
- SuperCable® and Steel Wires
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 May 2026to Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 and Sex:
- 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.
- Language Competence: The subject must possess sufficient German language skills to accurately complete the postoperative survey
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- Travel Capability: The subject must have the ability to travel for all planned study visits, including scheduled CT scans
- Surgical Procedure: The subject must be scheduled for elective coronary artery bypass graft (CABG) procedures, as this is the focus of the investigation
- Adherence to Visit Schedule: The subject must be willing to adhere to all scheduled visits and undergo CT scans as outlined in the study protocol
Who cannot join
- Pharmacological Restrictions: Current use of corticosteroids or any immunosuppressive medication
- Prior Treatments and Therapies: History of radiation therapy to the thorax
- Reproductive Considerations:
- Pregnancy, or the intent to become pregnant during the study period
- Lactation or current breastfeeding
- Allergic Reactions: Known allergic reactions to components of the conventional steel wire or SuperCable, specifically any known metal allergies (e.g., nickel or titanium).
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- Example: Patients with a documented history of nickel allergy, including previous adverse reactions to products such as sternal cerclages, will be excluded
- Infectious or Febrile Conditions: Any febrile illness occurring immediately before the scheduled surgery
- Concurrent Investigational Treatments: Treatment with another investigational drug or medical device within two months preceding surgery, as well as during the current investigation
- Surgical History: Subjects who have undergone prior sternotomy and osteosynthesis (i.e., re-do patients) will be excluded
- Anatomical Considerations:
- Known sternal deformities that could compromise the outcome of the investigation
- Off-midline sternotomy approaches, as these do not align with the surgical technique under investigation
- Patient Residence and Follow-Up Feasibility: Subjects residing in remote regions, including those from interstate or overseas, where follow-up and adherence to the scheduled visits might be compromised
- Other Specific Exclusions: Any additional criteria specific to the disease under investigation or identified by the investigator based on medical judgment (e.g., clinically significant concomitant disease states such as renal failure, hepatic dysfunction, or cardiovascular disease, if these conditions are deemed to interfere with study outcomes)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich
Hector Rodriguez, PD Dr. med., +41 43 253 26 87, hector.rodriguez@usz.ch
About this study
Official title: Prospective-randomized Trial to Demonstrate Superiority of SuperCable vs. Conventional Steel Wire for Closure After a Median Sternotomy
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.
- Conditions
- Sternotomy
- Being tested
- SuperCable®, Steel Wires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuperCable®Device
Initially, CABG procedure is performed in standard fashion. In the intervention group, sternal closure is performed using the SuperCable® Sternotomy Closure System.
Steel WiresDevice
Initially, CABG procedure is performed in standard fashion. In the control group, sternal closure is performed using conventional USP 7 (United States Pharmacopeia size-designation system) tool steel wires (Fumedica AG).
| Study group | Role | What they receive |
|---|---|---|
| SuperCable® | Experimental | In the intervention group, sternal closure is performed using the SuperCable® Sternotomy Closure System. Receives: Device: SuperCable® |
| Steel wires | Active comparator | In the control group, sternal closure is performed using conventional USP 7 (United States Pharmacopeia size-designation system) tool steel wires. Receives: Device: Steel Wires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sternal bone healing
Sternal bone healing, assessed via multiplanar CT-scans and a validated quantitative scoring algorithm (Stacy et al., 2014).
Measured: day5, day90, day180 (might be waived depending on outcome on day90)
Secondary outcomes (8)
Length of Hospital Stay
Length of Hospital Stay is reported
Measured: day90 (Visit 3)
Postoperative pain assessed by using a 10-point visual analog scale (VAS)
Postoperative pain assessed by using a 10-point visual analog scale (VAS) throughout study. from 0 (no pain) to 10 (most intense pain imaginable)
Measured: day1, day5, day90, day180
Total use of opioid-like drugs
Use of opioid-like drugs is reported using a Pain-Medicine conversion tool, throughout study
Measured: day1, day5, day90, day180
Upper Extremity Functional Index Score (UEFI)
Upper Extremity Functional Index Score (UEFI) is collected. Several items where patients rate their difficulty performing specific activities on a scale from 0 (extreme difficulty) to 4 (no difficulty)
Measured: day90, day180
Postoperative Quality of Recovery Scale (PostopQRS)
Postoperative Quality of Recovery Scale (PostopQRS) is assessed. It is principally comprised of a number of questions that objectively measure patient recovery, which are clustered into five different domains (physiological, emotive, nociceptive, activities of daily living, and cognitive) and one self-assessment domain.
Measured: day90, day180
Functional Difficulty Questionnaire (FDQ)
Functional Difficulty Questionnaire (FDQ) will be conducted
Measured: day90, day180
Composite of all complications related to sternal osteosynthesis (i.e., sternal dehiscence, re-operation due to sternal wound healing, wound infections)
Complications will be collected
Measured: day1, day5, day90, day180
Assessment of sternal stability as determined by ultrasound measurement of sternal motion
Assessment of sternal stability as determined by ultrasound
Measured: day5, day90, day180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start29 May 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SternotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251881
- Sponsor's protocol ID
- 2025-D0040
- Other IDs
- HumRes67145
- Acronym
- SURE
- Status last verified
- Apr 2026
- First submitted
- 24 Oct 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes