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Trial registered on ANZCTR


Registration number
ACTRN12618000976280
Ethics application status
Approved
Date submitted
6/06/2018
Date registered
8/06/2018
Date last updated
14/11/2018
Date data sharing statement initially provided
14/11/2018
Date results information initially provided
14/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Keeping your Cool: Simple reusable neck cooler for surgeons performing surgery.
Scientific title
Effect of a simple reusable neck cooler on surgeon comfort and perspiration: A pilot randomised control trial.
Secondary ID [1] 295106 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgeon perspiration 308182 0
Surgeon comfort 308183 0
Surgical site infection 308184 0
Condition category
Condition code
Public Health 307216 307216 0 0
Health service research
Infection 307217 307217 0 0
Studies of infection and infectious agents
Surgery 307218 307218 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is a simple reusable neck cooler, to be worn by surgeons and surgical assistants . The neck cooler is applied prior to donning lead gowns in orthopaedic trauma surgery, and worn for the duration of the operation. Device used is Arctic Heat Neck Wrap, more information available here: http://www.arcticheat.com.au/product/neck-wrap/
Neck coolers were kept in theatre refrigerators at four degrees Celsius for a minimum of four hours prior to use. After use they were rinsed in tap water, dried with paper towel, and placed back in the refrigerator.
The researcher is present to ensure correct application of the neck cooler and provides the surgeon and surgical assistant a questionnaire to fill out at the end of the operation.
Intervention code [1] 301443 0
Treatment: Devices
Comparator / control treatment
Comparator is normal practice, donning lead gowns in orthopaedic trauma surgery.
Control group
Active

Outcomes
Primary outcome [1] 306167 0
Surgeon/surgical assistant Perspiration - Subjective measure.
This was recorded using a questionnaire given to surgeon and surgical assistants by the researcher. This was designed specifically for this study. Perspiration was reported on a 10 point Likert-type scale where 0 is no subjective perspiration and 10 is unbearable subjective perspiration.
Timepoint [1] 306167 0
During the operation - recorded at the conclusion of the case.
Primary outcome [2] 306168 0
Surgeon/surgical assistant discomfort caused by atmosphere - subjective.
This was recorded using a questionnaire given to surgeon and surgical assistants by the researcher. This was designed specifically for this study. discomfort was reported on a 10 point Likert-type scale where 0 is no subjective discomfort and 10 is unbearable subjective discomfort.
Timepoint [2] 306168 0
During the case, recorded at the conclusion of the case.
Secondary outcome [1] 347760 0
Surgeon/surgical assistant reported adverse events.
A free text section in the questionnaire was available for concerns and adverse events. Participants were able to report any adverse effect e.g. headaches, loosening of neck cooler, burns.
Timepoint [1] 347760 0
During the operation, up to the point of removing the neck cooler (generally within 15 minutes of case conclusion) - recorded at the conclusion of the case.

Eligibility
Key inclusion criteria
Surgeons and surgical assistants at the study site who scrub into operations meeting the below clinical criteria:
Orthopaedic pathology requiring Image Intensifier use in surgery.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Refusal of participation by either surgeon or surgical assistant, study investigators not present.
Lack of neck cooler availability (i.e. have not been allowed to cool down in fridge between uses).

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)
Allocation was concealed at the time of inclusion into the study. The researcher assessed whether a surgical case was eligible for inclusion into the study.
After inclusion in the study, the researcher would access random.org and generate a random number, which would allocate the surgical case to either intervention or control as per the sequence generation box below.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random.org random number generation was used for each new case, after assessing for eligibility and inclusion in the study. The researcher would access Random.org and generate a number from 1 to 100 using their "true random number generator". An odd number resulted in allocation to the intervention group, whilst an even number resulted in allocation to the control group.
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
Normally distributed continuous variables were presented using mean and standard deviation (SD). Ordinal and skewed data were presented using median and interquartile range (IQR). Statistical analysis was performed using Stata v14.0 (Statacorp, TX, USA). To account for the effect within surgeon and in between surgeons, we performed a multilevel mixed effects linear regression with random effects, adjusting for potential confounders.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11083 0
Sandringham Hospital - Sandringham
Recruitment postcode(s) [1] 22894 0
3191 - Sandringham

Funding & Sponsors
Funding source category [1] 299695 0
Self funded/Unfunded
Name [1] 299695 0
Dr Adam Wertheimer
Address [1] 299695 0
Sandringham Hospital
193 Bluff Rd
Sandringham VIC 3191
Country [1] 299695 0
Australia
Primary sponsor type
Individual
Name
Dr Adam Wertheimer
Address
Sandringham Hospital
193 Bluff Rd
Sandringham VIC 3191
Country
Australia
Secondary sponsor category [1] 299036 0
None
Name [1] 299036 0
Address [1] 299036 0
Country [1] 299036 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300591 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 300591 0
The Alfred Hospital
55 Commercial Rd
Melbourne VIC 3004
Ethics committee country [1] 300591 0
Australia
Date submitted for ethics approval [1] 300591 0
Approval date [1] 300591 0
21/04/2017
Ethics approval number [1] 300591 0
175/17

Summary
Brief summary
Background: Infection in orthopaedic surgery can be catastrophic. Increased perspiration from theatre staff has been associated with higher rates of wound contamination. Wearing lead safety gowns, which is often done during surgery to allow the use of image intensifier, may result in heavy perspiration.
Aim: We aimed to determine feasibility of wearing a neck cooling device during surgery and whether it reduced surgeons’ perspiration levels and decreased the negative impact on surgeons’ comfort levels during orthopaedic procedures requiring the use of lead gowns.
Method: A pilot randomised control trial was conducted. Surgeons were randomised to either wearing the neck cooling device (intervention) or not wearing the device (control). Procedure duration, theatre temperature, humidity and perceived technical difficulty of operation were recorded. After the procedure, surgeons completed a questionnaire documenting how the temperature and humidity had a negative effect on their comfort and perceived level of perspiration. Multilevel mixed effects linear regression with random effects, adjusting for potential confounders was performed.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 84142 0
Dr Adam Wertheimer
Address 84142 0
Department of Orthopaedic Surgery
Sandringham Hospital
193 Bluff Rd
Sandringham VIC 3191
Country 84142 0
Australia
Phone 84142 0
+61 437422038
Fax 84142 0
Email 84142 0
apwertheimer@gmail.com
Contact person for public queries
Name 84143 0
Dr Adam Wertheimer
Address 84143 0
Department of Orthopaedic Surgery
Sandringham Hospital
193 Bluff Rd
Sandringham VIC 3191
Country 84143 0
Australia
Phone 84143 0
+61 437422038
Fax 84143 0
Email 84143 0
apwertheimer@gmail.com
Contact person for scientific queries
Name 84144 0
Dr Adam Wertheimer
Address 84144 0
Department of Orthopaedic Surgery
Sandringham Hospital
193 Bluff Rd
Sandringham VIC 3191
Country 84144 0
Australia
Phone 84144 0
+61 437422038
Fax 84144 0
Email 84144 0
apwertheimer@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This option was added after completion of the trial. We have opted not to make these data available because it was not cleared by our ethics board to do so.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 61 0
Wertheimer, A. , Kirzner, N. , Olaussen, A. , Abetz, J. , Martin, C. and Jones, C. (2018), Keeping your cool – a simple reusable neck cooler in orthopaedic surgery: a pilot randomized controlled trial. ANZ Journal of Surgery. . doi:10.1111/ans.14902
Date of publication: 10th October 2018
Attachments [1] 61 0
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
The use of a neck cooling device appeared to improve surgeon comfort and reduce perspiration, without any serious adverse events.