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Should face-masks be worn by non-scrubbed operating room staff?

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000110482
Acronym
(the MASK trial)
Enrollment
620
Registered
2007-02-07
Start date
2007-03-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 b

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.

Sponsors

Joan Webster
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Non-scrubbed operating room staff (including anaesthists).

Exclusion criteria

Non-consenting staff

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026