Surgery
Conditions
Keywords
CFU, surgery site
Brief summary
The objective of this study is to determine whether the Air Barrier System (ABS) reduces airborne colony-forming units (e.g. bacteria) present at surgery sites during posterior spinal procedures
Detailed description
The ABS 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 ABS can reduce the presence of airborne colony-forming units at the surgery site during posterior spinal procedures.
Interventions
Device is deployed adjacent to the surgery site and activated.
Sponsors
Nimbic Systems, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients undergoing lumbar and cervical laminectomy with instrumentation.
Exclusion criteria
* Active infection * Prior prosthesis infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CFU Density | Surgical case CFU density will be determined at up to 1 month from completion of surgical cases | Colony-forming unit density at incision site (CFU/m3) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Device Subject does not receive ABS system | 20 |
| Air Barrier System Device Device is deployed adjacent to the surgery site and activated.
Air Barrier System device: Device is deployed adjacent to the surgery site and activated. | 18 |
| Total | 38 |
Baseline characteristics
| Characteristic | No Device | Air Barrier System Device | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 13 Participants | 28 Participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 18 Participants | 18 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 18 |
| serious Total, serious adverse events | 0 / 20 | 0 / 18 |
Outcome results
Primary
CFU Density
Colony-forming unit density at incision site (CFU/m3)
Time frame: Surgical case CFU density will be determined at up to 1 month from completion of surgical cases
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Device | CFU Density | 5.05 CFU/m^3 |
| Air Barrier System Device | CFU Density | 1.55 CFU/m^3 |