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The effect of Space Suits on intraoperative wound contamination in patients undergoing knee replacement surgery.

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612001029886
Enrollment
75
Registered
2012-09-25
Start date
2013-08-03
Completion date
2014-08-10
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

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

Interventions

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.

Sponsors

Northshore Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

All patients under Mr Bayan for an elective primary knee joint replacement, who consent to inclusion in the study.

Exclusion criteria

No exclusion criteria - must be primary elective knee joint replacement

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026