Surgery
Conditions
Keywords
CFU, surgery site
Brief summary
The objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g. bacteria) present at a surgery site during spinal procedures.
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 at the surgery site during spinal procedures.
Interventions
Device is deployed adjacent to the surgery site and activated so that the filtered air emits over the site.
Sponsors
Nimbic Systems, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Candidate for instrumented posterior lumbar interbody fusion
Exclusion criteria
* Prior history of infection * Revision surgery * Screens positive for MRSA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgery Site CFU Density | Ten-minute intervals throughout procedure | CFU culture counts for samples taken in surgery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Device | 13 |
| Device Deployed | 10 |
| Total | 23 |
Baseline characteristics
| Characteristic | No Device | Device Deployed | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 3 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 7 Participants | 15 Participants |
| Region of Enrollment United States | 13 participants | 10 participants | 23 participants |
| Sex: Female, Male Female | 7 Participants | 5 Participants | 12 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 13 | 0 / 10 |
Outcome results
Primary
Surgery Site CFU Density
CFU culture counts for samples taken in surgery.
Time frame: Ten-minute intervals throughout procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Device | Surgery Site CFU Density | 3.08 CFU/m3 |
| Device Deployed | Surgery Site CFU Density | 1.73 CFU/m3 |