Device to Reduce Surgery Site Contamination

Nimbic Systems

Status: Completed

Conditions: Surgery

Treatments: Device: Air Barrier System Device; Device: Sham Air Barrier System device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00972153

ABS001-0912403

Details and patient eligibility

About

The objective of this study is to determine whether the Air Barrier System device reduces airborne particulate and airborne colony forming units present at a surgery site.

Full description

The Air Barrier System is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. This study examines the hypothesis that the Air Barrier System can reduce the presence of airborne colony-forming units (e.g. bacteria colonies) and particulate at the surgery site.

Enrollment: 29 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Candidate for primary total hip arthroplasty

Exclusion criteria

• Prior history of infection
• Revision arthroplasty
• Screens positive for MRSA
• Undergoing hemiarthroplasty or resurfacing

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 3 patient groups

No device used

No Intervention group

Device attached, not activated

Sham Comparator group

Treatment:

Device: Sham Air Barrier System device

Device deployed and activated

Experimental group

Treatment:

Device: Air Barrier System Device