Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000755033
Ethics application status
Submitted, not yet approved
Date submitted
9/09/2010
Date registered
13/09/2010
Date last updated
23/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Postoperative Use of a Brace for Sternum Study
Scientific title
Patients undergoing median sternotomy who postoperatively wear a sternal brace garment device compared with patients who don't experience less pain, less sternal instability and functional difficulties.
Secondary ID [1] 252482 0
No secondary ID
Universal Trial Number (UTN)
U1111-1116-6201
Trial acronym
PUBS Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative sternal complications 257983 0
Condition category
Condition code
Physical Medicine / Rehabilitation 258146 258146 0 0
Physiotherapy
Surgery 258147 258147 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 257035 0
Treatment: Devices
Comparator / control treatment
Standard Treatment will be routine sternal precautions post-operatively which includes holding a pillow against the chest when coughing. This will last for the duration of the patient's in-hospital stay which will be approximately 7 days.
Control group
Active

Outcomes
Primary outcome [1] 259194 0
Pain (Visual Anaogue Scale)
Timepoint [1] 259194 0
Day 1 post extubation, Day 3 post extubation, Day of discharge, 6 weeks post sternotomy
Secondary outcome [1] 265558 0
Sternal Instability Scale
Timepoint [1] 265558 0
Day 1 post extubation, Day 3 post extubation, Day of discharge
Secondary outcome [2] 265559 0
Functional Difficulties Questionnaire
Timepoint [2] 265559 0
Day 1 post extubation, Day 3 post extubation, Day of discharge, 6 weeks post sternotomy
Secondary outcome [3] 265560 0
Patient satisfaction and mood survey
Timepoint [3] 265560 0
Day 1 post extubation, Day 3 post extubation, Day of discharge, 6 weeks post sternotomy
Secondary outcome [4] 265561 0
Inspiratory Reserve Volume (as measured by a portable spirometer device)
Timepoint [4] 265561 0
Day 1 post extubation, Day 3 post extubation, Day of discharge

Eligibility
Key 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
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1)heart transplant and Ventricular Assist Device patients
2)contraindication to wearing sternal brace
3)irradiation of the thorax

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be enrolled and assigned a unique study identification number. On the day of the operation they will be allocated according to the treatment arm specified in a sealed, opaque envelope with a unique randomisation number. The investigator who assigns study identification numbers will not be involved in the process of allocating and/or opening sealed, opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation will be obtained by using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5833 0
Monash Medical Centre - Clayton campus - Clayton

Funding & Sponsors
Funding source category [1] 257632 0
Commercial sector/Industry
Name [1] 257632 0
Qualiteam S.R.L
Country [1] 257632 0
Australia
Primary sponsor type
Hospital
Name
Monash Medical Centre Human Research and Ethics Committee
Address
Monash Medical Centre
246 Clayton Rd
Clayton
VIC 3168
Country
Australia
Secondary sponsor category [1] 256868 0
None
Name [1] 256868 0
Address [1] 256868 0
Country [1] 256868 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 259648 0
Ethics committee address [1] 259648 0
Ethics committee country [1] 259648 0
Date submitted for ethics approval [1] 259648 0
17/03/2016
Approval date [1] 259648 0
Ethics approval number [1] 259648 0

Summary
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.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 31536 0
Dr Yi Chen
Address 31536 0
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Country 31536 0
Australia
Phone 31536 0
+61 3 95946666
Fax 31536 0
Email 31536 0
[email protected]
Contact person for public queries
Name 14783 0
Dr Dr Yi Chen
Address 14783 0
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Country 14783 0
Australia
Phone 14783 0
+61 3 95946666
Fax 14783 0
Email 14783 0
[email protected]
Contact person for scientific queries
Name 5711 0
Dr Dr Yi Chen
Address 5711 0
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Country 5711 0
Australia
Phone 5711 0
+61 3 95946666
Fax 5711 0
Email 5711 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.