None listed
Conditions
Brief summary
This trial is a prospective randomised controlled trial comparing outcomes in patients who have undergone median sternotomy fitted with the QualiBreath sternal brace postoperatively with those who have not. Pain, sternal instability, patient satisfaction and functional activity level will be assessed.
Interventions
Intervention group to wear sternal brace garment (Qualibreath) post median sternotomy, during inpatient hospital stay. A median sternotomy is wear the breastbone is divided with a sternal saw to access the chest cavity and is then reapposed with a series of sternal wires. Chest supports can be grouped in two major types of products: 1. passive, non-elastic (rigid) bands, 2. semi-rigid or elastic bands (abdominal bands). Type 1 helps patients when they cough, sneeze etc, but cannot give any conti
Intervention group to wear sternal brace garment (Qualibreath) post median sternotomy, during inpatient hospital stay. A median sternotomy is wear the breastbone is divided with a sternal saw to access the chest cavity and is then reapposed with a series of sternal wires. Chest supports can be grouped in two major types of products: 1. passive, non-elastic (rigid) bands, 2. semi-rigid or elastic bands (abdominal bands). Type 1 helps patients when they cough, sneeze etc, but cannot give any continuous breathing support. Type 2 may give continuous breathing support but cannot help patients when they need extra help for extra pain. The Qualibreath device combines all advantages in one product: it gives continuous breathing support and it enables patients to get extra tightening support when needed. The sternal brace will be worn continuously and removed temporarily for showering. It will be worn for the duration of the patient's inhospital stay which is approximately 7 days.
Sponsors
Monash Medical Centre Human Research and Ethics Committee
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1)undergoing an operation which involves median sternotomy 2)ability to undertake visual testing and complete questionnaires 3)competence to provide informed consent
Exclusion criteria
1)heart transplant and Ventricular Assist Device patients 2)contraindication to wearing sternal brace 3)irradiation of the thorax
Outcome results
None listed