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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
86
Initially, CABG procedure is performed in standard fashion. In the intervention group, sternal closure is performed using the SuperCable® Sternotomy Closure System.
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).
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)
Length of Hospital Stay
Length of Hospital Stay is reported
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: day90, day180
Functional Difficulty Questionnaire (FDQ)
Functional Difficulty Questionnaire (FDQ) will be conducted
Time frame: 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
Time frame: day1, day5, day90, day180
Assessment of sternal stability as determined by ultrasound measurement of sternal motion
Assessment of sternal stability as determined by ultrasound
Time frame: day5, day90, day180
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