Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000546257
Ethics application status
Not yet submitted
Date submitted
3/07/2009
Date registered
7/07/2009
Date last updated
7/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of pre-operative clothing on body temperature before, during and after breast surgery
Scientific title
In patients having breast surgery does the use of a merino wool over-garment compared to a standard hospital gown reduce perioperative hypothermia
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perioperative hypothermia 237147 0
Condition category
Condition code
Other 237474 237474 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Merino wool over-garment, worn for at least 30 minutes prior to surgery. This would be given to the patient when they change out of their outdoor clothes and would be worn over the traditional hospital gown. The over-garment will be removed just prior to the transfer of the patient to the operating table.
Intervention code [1] 236862 0
Prevention
Comparator / control treatment
Traditional hospital gown only, also worn for at least 30 minutes prior to surgery.
Control group
Active

Outcomes
Primary outcome [1] 238275 0
Reduction in core to peripheral temperature gradients. Core measurements will be done with a tympanic thermometer and peripheral temperautres with skin surface electrodes. The measurements will be done on arrival to the surgical unit, prior to anaesthesia every 30 minutes thereafter until discharge from recovery.
Timepoint [1] 238275 0
During surgery and in recovery
Secondary outcome [1] 244648 0
Post-operative hypothermia and shivering
Timepoint [1] 244648 0
Measured in recovery
Secondary outcome [2] 244649 0
Recovery and hospital stay duration
Timepoint [2] 244649 0
Measured after discharge from hosptial notes
Secondary outcome [3] 244650 0
Post-operative complications eg wound infections, post-operative myocardial infarction. These will be assessed by review of patient notes after discharge.
Timepoint [3] 244650 0
Measured just after discharge from hospital notes
Secondary outcome [4] 244651 0
Subjective measures of comfort. This will be measured using a standardised questionnaire given to the patient the day after surgery.
Timepoint [4] 244651 0
Measured the day after surgery

Eligibility
Key inclusion criteria
Elective mastectomy or wide local excision with or without axillary node clearance

American Society of Anesthesiologists (ASA) grade I-III
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Body mass index >35kg/m2
Endocrine disease
Febrile pre-operatively
Vasoactive drugs

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 1867 0
New Zealand
State/province [1] 1867 0

Funding & Sponsors
Funding source category [1] 237248 0
Self funded/Unfunded
Name [1] 237248 0
Russell Clarke
Country [1] 237248 0
New Zealand
Primary sponsor type
Hospital
Name
Christchurch Hospital
Address
Riccarton Avenue
Private Bag 4710
Christchurch
Country
New Zealand
Secondary sponsor category [1] 236734 0
None
Name [1] 236734 0
Address [1] 236734 0
Country [1] 236734 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239350 0
Ethics committee address [1] 239350 0
Ethics committee country [1] 239350 0
Date submitted for ethics approval [1] 239350 0
10/07/2009
Approval date [1] 239350 0
Ethics approval number [1] 239350 0

Summary
Brief summary
The purpose of this study is to assess whether wearing a wool over-garment, that has been proven to be a good insulator in the laboratory, helps reduce post-operative hypothermia. The garment is renewable, recyclable and cheap to produce.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29837 0
Address 29837 0
Country 29837 0
Phone 29837 0
Fax 29837 0
Email 29837 0
Contact person for public queries
Name 13084 0
Russell Clarke
Address 13084 0
Christchurch Hospital
Riccarton Avenue
Private Bag 4710
Christchurch
Country 13084 0
New Zealand
Phone 13084 0
+64 210 706 254
Fax 13084 0
Email 13084 0
[email protected]
Contact person for scientific queries
Name 4012 0
Russell Clarke
Address 4012 0
Christchurch Hospital
Riccarton Avenue
Private Bag 4710
Christchurch
Country 4012 0
New Zealand
Phone 4012 0
+64 210 706 254
Fax 4012 0
Email 4012 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.