RecruitingACTRN12615000852550

Comparison of two different techniques to close the sternum following cardiac surgery

Comparison of sternal closure methods measuring pain and sternal stability following median sternotomy incision for cardiothoracic surgery


Sponsor

Alfred Health

Enrollment

120 participants

Start Date

Feb 1, 2016

Study Type

Interventional

Conditions

Summary

Current standard practice at The Alfred Hospital involves closing the sternum following cardiac surgery with stainless steel wires. Alternative sternal closing techniques also exist, however to date closure of the sternum using stainless steel wires remains the standard technique because of its low cost. The cable tie method of sternal closure however is a widely used sternal closure technique that is used as a standard method by many surgeons in Australia and around the world, as this method potentially provides better stability of the sternum and less postoperative sternal pain. The aim of this research is to compare the outcomes in patients who have their sternum closed either with the Zipfix cable ties or stainless steel wires. The researchers will investigate whether patients who have their sternum closed with Zipfix cable ties experience less pain compared to patients that have their sternum closed with stainless steel wires. They will also determine whether patients who have their sternum closed with the cable ties have reduced sternal mobility in the early postoperative period. We hypothesize that use of the zipfix system for sternal closure after cardiac surgery improves sternal stability and reduces post operative pain, compared to conventional stainless steel wires.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

After open heart surgery, surgeons close the breastbone (sternum) using either traditional stainless steel wires or a newer cable-tie system. This study compares the two methods to see if the cable-tie system provides a more stable closure and reduces pain after surgery. Patients will be randomly assigned to one of the two methods. You may be eligible if: - You are 18 years old or older - You are scheduled for open heart surgery that involves cutting through the breastbone (sternotomy) - You are able to understand and complete questionnaires You may NOT be eligible if: - You are having a heart transplant or receiving a ventricular assist device (VAD) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The aim of this research is to compare the outcomes in cardiac surgery patients who have sternal fixation using stainless steel wires (current practice at The Alfred) with patients who have sternal f

The aim of this research is to compare the outcomes in cardiac surgery patients who have sternal fixation using stainless steel wires (current practice at The Alfred) with patients who have sternal fixation using Zipfix cable ties (intervention). Applying the Zipfix cable ties involves using 5 biocompatible cable ties looped around both halves of the sternum using a removable needle, then they are tightened to pull the sternal halves back together. The remaining length of the cable tie is then cut using a specialized cutting device. Cardiac surgeons will perform the sternal closure on patients using the Zipfix system.


Locations(1)

The Alfred - Prahran

VIC, Australia

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ACTRN12615000852550