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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000852550
Enrollment
120
Registered
2015-08-17
Start date
2016-02-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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 the

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.

Sponsors

Alfred Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

The inclusion criteria are: * undergoing an operation involving median sternotomy * age greater than 18 years * competence to provide informed consent * ability to undertake the visual testing and complete questionnaires * redo sternotomy will be included

Exclusion criteria

The exclusion criteria are: * heart transplant and VAD patients

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026