Device to Reduce Surgery Site Contamination

Nimbic Systems, LLC29 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Surgery

Interventions

Air Barrier System DeviceDEVICE

Device is deployed adjacent to the surgery site and activated so that the filtered air emits over the surgery site.

Sham Air Barrier System deviceDEVICE

Device is deployed to the surgery site, but the airflow is not activated. This intervention is used to determine any effects that the presence of the device alone may have.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Candidate for primary total hip arthroplasty Exclusion Criteria: * Prior history of infection * Revision arthroplasty * Screens positive for MRSA * Undergoing hemiarthroplasty or resurfacing

Locations (1)

Texas Orthopedic Hospital

Houston, Texas, United States

Outcomes

Primary Outcomes

Surgery Site CFU Density

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.

Time frame: Ten minute intervals throughout surgery

Secondary Outcomes

Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter

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.

Time frame: Ten minute intervals throughout surgery

Data from ClinicalTrials.gov

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