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Trial registered on ANZCTR


Registration number
ACTRN12612001029886
Ethics application status
Approved
Date submitted
3/09/2012
Date registered
25/09/2012
Date last updated
17/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Space Suits on intraoperative wound contamination in patients undergoing knee replacement surgery.
Scientific title
In patients undergoing primary total knee joint replacement at waitakere hospital, is there a difference between Space Suits, space suits with glove taping and conventional gowns in terms of wound contamination as detected by PCR and TSMI.
Secondary ID [1] 280944 0
Nil known
Universal Trial Number (UTN)
U1111-1133-0771
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound contamination as a marker for deep infection during primary total knee joint replacement 287041 0
Condition category
Condition code
Surgery 287368 287368 0 0
Other surgery
Infection 287637 287637 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Surgical gowns used during total knee joint replacement

(Intervention 1) the operating surgeons and scrub nurse will wear standard Stryker T5 spacesuits.

(Intervention 2) the operating surgeons and scrub nurse will wear standard Stryker T5 spacesuits with tape applied the gown/glove interface on both cuffs.
Intervention code [1] 285380 0
Prevention
Intervention code [2] 285726 0
Treatment: Surgery
Comparator / control treatment
(Control for intervention 1, space suits without tape) the operating surgeons and scrub nurse will wear standard surgical gowns.
(Control for intervention 2, space suits with tape.) the operating surgeons and scrub nurse will wear standard Stryker T5 spacesuits.
Control group
Active

Outcomes
Primary outcome [1] 287641 0
wound contamination as measured by PCR and TSMI analysis of wound samples
Timepoint [1] 287641 0
Control taken at time 0
During surgery taken at 1 hour into the operation
Secondary outcome [1] 298989 0
Nil
Timepoint [1] 298989 0
Nil

Eligibility
Key inclusion criteria
All patients under Mr Bayan for an elective primary knee joint replacement, who consent to inclusion in the study.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria - must be primary elective knee joint replacement

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)
Patients are allocated by numbered, sealed, opaque envelopes opened just prior to the operation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence is generated through a random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Surgical staff can not be blinded in this study. However the investigator reponsible for data processing and analysis is blinded to the patient groups.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

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 outside Australia
Country [1] 4454 0
New Zealand
State/province [1] 4454 0
Auckland

Funding & Sponsors
Funding source category [1] 285734 0
Charities/Societies/Foundations
Name [1] 285734 0
Wishdone trust
Address [1] 285734 0
PO Box 5545
Lambton Quay
Wellington 6145
New Zealand
Country [1] 285734 0
New Zealand
Primary sponsor type
Hospital
Name
Northshore Hospital
Address
124 Shakespeare Road Westlake 0622
Auckland
Country
New Zealand
Secondary sponsor category [1] 284559 0
University
Name [1] 284559 0
University of Auckland, School of biomedical sciences
Address [1] 284559 0
85 Park Road
Grafton
Auckland 1023
Country [1] 284559 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287737 0
Northern Regional A ethics committee
Ethics committee address [1] 287737 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 287737 0
New Zealand
Date submitted for ethics approval [1] 287737 0
Approval date [1] 287737 0
04/09/2012
Ethics approval number [1] 287737 0
12/NTA/11

Summary
Brief summary
Deep infection following total joint replacement remains a devastating complication for both the patient and the health sector. It is estimated that a single deep infection following a THJR incurs a cost of around $150,000. To combat this problem, Charnely pioneered the use of body exhaust suits which were later validated. A large MRC trial reported by Lidwel in the 1980s showed a marked reduction in infection rates with the use of laminar flow ventilation and body exhaust suits (BES), leading to their widespread introduction.

However, modern body suit systems have eschewed the use of the full body exhaust system due to its cumbersome nature and cost. These ‘Space Suit’ systems have not been studied as extensively as the previous BES suits and use a helmet based fan. This fan creates a positive pressure situation inside the gown which is quite distinct from the previous BES suits, and may lead to disruption of the theatre airflow and cause particles shed from the surgical team to be deposited within the sterile field.

The New Zealand Joint Registry data suggests that spacesuit use is linked to an increase in the rate of early joint arthroplasty infections. This runs counter to expectations, and many surgeons have concluded the registry data is flawed. This randomised controlled trial will use real tissue samples during TKJR to investigate whether the use of spacesuits increases the likelihood of wound contamination, and therefore infections. The analysis of wound samples is to be done by PCR and TSMI which has been shown to be a sensitive and specific measure of real wound contamination
Trial website
Trial related presentations / publications
Presented at NZOA Registrar paper day 2015, NZOA ASM 2015 and Ross Nicholson paper day 2016
Public notes

Contacts
Principal investigator
Name 34513 0
Dr Otis Shirley
Address 34513 0
Department of orthopaedics, Northshore hospital, 124 Shakespeare Road Westlake 0622, Auckland
Country 34513 0
New Zealand
Phone 34513 0
+6421979702
Fax 34513 0
Email 34513 0
emailotiss@gmail.com
Contact person for public queries
Name 17760 0
Dr Otis Shirley
Address 17760 0
Department of orthopaedics, Northshore hospital, 124 Shakespeare Road Westlake 0622, Auckland
Country 17760 0
New Zealand
Phone 17760 0
+649486 8900
Fax 17760 0
Email 17760 0
emailotiss@gmail.com
Contact person for scientific queries
Name 8688 0
Dr Otis Shirley
Address 8688 0
Department of orthopaedics, Northshore hospital, 124 Shakespeare Road Westlake 0622, Auckland
Country 8688 0
New Zealand
Phone 8688 0
+649486 8900
Fax 8688 0
Email 8688 0
emailotiss@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary