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

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: Not yet recruiting
• Conditions: Sternotomy
• Intervention / Treatment: Device: SuperCable®; Device: Steel Wires

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hector Rodriguez, PD Dr. med.; Phone Number: +41432532687; Email: hector.rodriguez@usz.ch

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Sternal bone healing	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

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay	Length of Hospital Stay is reported	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)	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	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)	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.	day90, day180
Functional Difficulty Questionnaire (FDQ)	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)	Complications will be collected	day1, day5, day90, day180
Assessment of sternal stability as determined by ultrasound measurement of sternal motion	Assessment of sternal stability as determined by ultrasound	day5, day90, day180

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: October 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID 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