Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000110482
Ethics application status
Not yet submitted
Date submitted
30/01/2007
Date registered
7/02/2007
Date last updated
7/02/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Should face-masks be worn by non-scrubbed operating room staff?
Scientific title
P: non-scrubbed operating room staff
I: no masks during procedures
C: wearing masks during procedures
O: Primary - Surgical site infection
Secondary - Cost, compliance rate
Universal Trial Number (UTN)
Trial acronym
(the MASK trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical site infection 1604 0
Condition category
Condition code
Surgery 1708 1708 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Operating theatres will be randomly assigned to be either MASK or NO-MASK areas. Allocation of the theatres, according to the randomisation list, will occur immediately before the commencement of the operation list and will be concealed until then. All non-scrubbed oroperating room staff will be asked to either wear or not wear masks during the operating list. The length of time spent in the theatre by any member of the non-scrubbed team will vary according to their role in the team but may be between minutes to several hours.
Intervention code [1] 1579 0
Treatment: Other
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 2379 0
Surgical site infection: Any surgical site infection occuring before discharge or up to two weeks post discharge.
Timepoint [1] 2379 0
Secondary outcome [1] 4128 0
Cost
Timepoint [1] 4128 0
This will be assessed at the end of the in-patient episode but will include any re-admission related costs.
Secondary outcome [2] 4129 0
Compliance rate
Timepoint [2] 4129 0
On at least one day a week, an observational visit will be made to the operating rooms to monitor compliance with the protocol.

Eligibility
Key inclusion criteria
Non-scrubbed operating room staff (including anaesthists).
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-consenting staff

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 concealment will involve contacting the holder of the allocation schedule at the central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomized list will be produced to ensure allocation is unpredictable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
620
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1853 0
Government body
Name [1] 1853 0
Queensland Health Nursing Research Grant
Country [1] 1853 0
Australia
Primary sponsor type
Individual
Name
Joan Webster
Address
Country
Secondary sponsor category [1] 1668 0
Individual
Name [1] 1668 0
Anndrea Flint
Address [1] 1668 0
Country [1] 1668 0

Ethics approval
Ethics application status
Not yet submitted

Summary
Brief summary
The surgical facemask has been in use in operating theatres to protect patients
from infection since the late 1800s. More recently, the focus has changed from
protecting the patient, to protecting staff from splashes of body fluids. Although the
mask is clearly useful for scrubbed staff for this purpose, it remains unclear
whether wearing face-masks by unscrubbed operating room staff results in any
benefit or harm to the patient undergoing surgery. The objective of the current
study is to use a randomised controlled trial to investigate the effect of wearing a
face mask, by non-scrubbed operating room staff, on surgical site infection
(primary outcome) and cost (secondary outcome). This will be the largest such
trial to be undertaken and results will have broad implications for Queensland
Health across the state.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27513 0
Address 27513 0
Country 27513 0
Phone 27513 0
Fax 27513 0
Email 27513 0
Contact person for public queries
Name 10768 0
Joan Webster
Address 10768 0
Centre for Clinical Nursing
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country 10768 0
Australia
Phone 10768 0
+61 7 36368590
Fax 10768 0
Email 10768 0
[email protected]
Contact person for scientific queries
Name 1696 0
Joan Webster
Address 1696 0
Centre for Clinical Nursing
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country 1696 0
Australia
Phone 1696 0
+61 7 36368590
Fax 1696 0
Email 1696 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.