MedPath

Device to Reduce Surgery Site Contamination

Not Applicable
Completed
Conditions
Surgery
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.

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
Primary Outcome Measures
NameTimeMethod
Surgery Site CFU DensityTen 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
NameTimeMethod
Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic MeterTen 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

Texas Orthopedic Hospital
🇺🇸Houston, Texas, United States

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