Health TrialsbyHealthPanel

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

ConditionSternotomy
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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 Wires

    Device

    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).

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: SuperCable®Experimental treatment 1 intervention
Group B: Steel wiresActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sternal bone healing

Sternal bone healing, assessed via multiplanar CT-scans and a validated quantitative scoring algorithm (Stacy et al., 2014).

Time frame
day5, day90, day180 (might be waived depending on outcome on day90)

Secondary outcomes

1

Length of Hospital Stay

Length of Hospital Stay is reported

Time frame
day90 (Visit 3)
2

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)

Time frame
day1, day5, day90, day180
3

Total use of opioid-like drugs

Use of opioid-like drugs is reported using a Pain-Medicine conversion tool, throughout study

Time frame
day1, day5, day90, day180
4

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)

Time frame
day90, day180

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Zurich

Lead sponsor

Source ClinicalTrials.gov
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