Device to Reduce Surgery Site Contamination

Not Applicable

Completed

• Conditions: Surgery
• Interventions: Device: Sham Air Barrier System device; Device: Air Barrier System Device

• Registration Number: NCT00972153
• Lead Sponsor: Nimbic Systems, LLC

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2009-09-02
• Study First Submitted QC: 2009-09-03
• Study First Posted: 2009-09-04
• Results First Submitted: 2010-04-22
• Results First Submitted QC: 2010-04-22
• Results First Posted: 2010-05-18
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-14
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Candidate for primary total hip arthroplasty

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Device attached, not activated	Sham Air Barrier System device	-
Device deployed and activated	Air Barrier System Device	-

Primary Outcome Measures

Name	Time	Method
Surgery Site CFU Density	Ten minute intervals throughout surgery	Colony forming unit counts were collected from the air within 5 cm of the surgical wound using a bioaerosol "slit" sampling device. Air was drawn through a sterile PVC tubing located at the incision and impacted upon media (TSA 5% sheep's blood) plates located in the sampling device. The plates were exchanged every 10 minutes throughout the procedure. Values are presented as CFU/cubic meter.

Secondary Outcome Measures

Name	Time	Method
Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter	Ten minute intervals throughout surgery	Airborne particulate was measured using a particle analyzer (LASAIR II 310B). The analyzer sampled continuously during surgery at a rate of 28.3 L/min and recorded data at one-minute intervals. The samples were collected through a length of sterile PVC tubing with the end placed adjacent to the CFU sample tubing, within 5 cm of the surgical incision. Particles of various diameters were obtained; particles of size \>10 micrometer had the strongest correlation to the presence of CFUs at the incision site.

Trial Locations

Locations (1)

Texas Orthopedic Hospital; 🇺🇸 Houston, Texas, United States