ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Condition category

Condition code

Surgery

Other surgery

Infection

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]

Prevention

Intervention code [2]

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]

wound contamination as measured by PCR and TSMI analysis of wound samples

Timepoint [1]

Control taken at time 0
During surgery taken at 1 hour into the operation

Secondary outcome [1]

Nil

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/10/2012

Actual

3/08/2013

Date of last participant enrolment

Anticipated

Actual

10/08/2014

Date of last data collection

Anticipated

Actual

10/08/2014

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Wishdone trust

Address [1]

PO Box 5545
Lambton Quay
Wellington 6145
New Zealand

Country [1]

New Zealand

Primary sponsor type

Hospital

Name

Northshore Hospital

Address

124 Shakespeare Road Westlake 0622
Auckland

Country

New Zealand

Secondary sponsor category [1]

University

Name [1]

University of Auckland, School of biomedical sciences

Address [1]

85 Park Road
Grafton
Auckland 1023

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Regional A ethics committee

Ethics committee address [1]

Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington  6145

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

04/09/2012

Ethics approval number [1]

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

Dr Otis Shirley

Address

Department of orthopaedics, Northshore hospital, 124 Shakespeare Road Westlake 0622, Auckland

Country

New Zealand

Phone

+6421979702

Fax

emailotiss@gmail.com

Contact person for public queries

Name

Otis Shirley

Address

Department of orthopaedics, Northshore hospital, 124 Shakespeare Road Westlake 0622, Auckland

Country

New Zealand

Phone

+649486 8900

Fax

emailotiss@gmail.com

Contact person for scientific queries

Name

Otis Shirley

Address

Department of orthopaedics, Northshore hospital, 124 Shakespeare Road Westlake 0622, Auckland

Country

New Zealand

Phone

+649486 8900

Fax

emailotiss@gmail.com

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically