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

July 29, 2026 updated by: University of Zurich

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Switzerland
      • Zurich, Switzerland
        • Recruiting
        • University Hospital Zurich
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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).

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SuperCable®
In the intervention group, sternal closure is performed using the SuperCable® Sternotomy Closure System.
Device: SuperCable®
Initially, CABG procedure is performed in standard fashion. In the intervention group, sternal closure is performed using the SuperCable® Sternotomy Closure System.
Active Comparator: Steel wires
In the control group, sternal closure is performed using conventional USP 7 (United States Pharmacopeia size-designation system) tool steel wires.
Device: Steel Wires
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sternal bone healing
Time Frame: day5, day90, day180 (might be waived depending on outcome on day90)
Sternal bone healing, assessed via multiplanar CT-scans and a validated quantitative scoring algorithm (Stacy et al., 2014).
day5, day90, day180 (might be waived depending on outcome on day90)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay
Time Frame: day90 (Visit 3)
Length of Hospital Stay is reported
day90 (Visit 3)
Postoperative pain assessed by using a 10-point visual analog scale (VAS)
Time Frame: day1, day5, day90, day180
Postoperative pain assessed by using a 10-point visual analog scale (VAS) throughout study. from 0 (no pain) to 10 (most intense pain imaginable)
day1, day5, day90, day180
Total use of opioid-like drugs
Time Frame: day1, day5, day90, day180
Use of opioid-like drugs is reported using a Pain-Medicine conversion tool, throughout study
day1, day5, day90, day180
Upper Extremity Functional Index Score (UEFI)
Time Frame: day90, day180
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)
day90, day180
Postoperative Quality of Recovery Scale (PostopQRS)
Time Frame: day90, day180
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.
day90, day180
Functional Difficulty Questionnaire (FDQ)
Time Frame: day90, day180
Functional Difficulty Questionnaire (FDQ) will be conducted
day90, day180
Composite of all complications related to sternal osteosynthesis (i.e., sternal dehiscence, re-operation due to sternal wound healing, wound infections)
Time Frame: day1, day5, day90, day180
Complications will be collected
day1, day5, day90, day180
Assessment of sternal stability as determined by ultrasound measurement of sternal motion
Time Frame: day5, day90, day180
Assessment of sternal stability as determined by ultrasound
day5, day90, day180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-D0040
  • HumRes67145 (Other Identifier: Human Research Switzerland)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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