A randomised controlled trial comparing sternal wires with sternal cabling for prevention of deep sternal wound infection in patients undergoing cardiac surgery
Phase 4
Completed
- Conditions
- Deep Sternal Wound InfectionSurgery - Surgical techniques
- Registration Number
- ACTRN12615000973516
- Lead Sponsor
- Mr Chris Merry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Our inclusion criteria were any patient of 18 years of age or older, presenting for first time elective, urgent or emergent cardiac surgery via full sternotomy and being able to provide informed consent.
Exclusion Criteria
Redo Sternotomy
Salvage surgery – CPR en route to theatre
Cardiac transplant
Left ventricular assist device insertion
Pregnant women
Patients with cognitive impairment
Intravenous drug users
Patients on opiate analgaesia pre-op
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of Deep Sternal Wound Infection at 30 days post-op. As defined by ANZSCTS (Australian and New Zealand Society of Cardiothoracic Surgeons): DSWI is defined by positive cultures taken from the patient’s sternal tissue or mediastinal biopsy at the time of reoperation.[30 days post-op]
- Secondary Outcome Measures
Name Time Method Requirement for sternal rewiring at 30 days post-op, assessed prospectively as all rewiring procedures were be performed in our unit<br>Furthermore, at routine outpatient follow-up any patients that required rewiring at another institution were recorded (there were none).<br><br><br>[30 days post-op];Pain scores at days 3 and 5 post-op<br>Pain scores were assessed using the Modified Brief Pain Inventory - Short Form (MBPI-SF)[Days 3 and 5 post-op];Analgaesia requirements at day 3, day 5 and on discharge<br>Analgaesia requirement was determined by a specific step-wise analgaesia protocol<br><br>Prospectively recorded on ward round as team reviewed the medication chart the analgaesia requirements for the previous 24 hours were recorded[Day 3 post-op, Day 5 post-op and on day of hospital discharge]