An interventional study of Air Barrier System device in Surgery, sponsored by Nimbic Systems, LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-17.
Sponsored by Nimbic Systems, LLC · Not applicable, Interventional, and Basic science
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
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.
Nimbic Systems, LLC is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subject does not receive ABS system
Device is deployed adjacent to the surgery site and activated.
Device: Air Barrier System device
Device is deployed adjacent to the surgery site and activated.
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
| Milestone | No Device | Air Barrier System Device |
|---|---|---|
| Started | 20 | 21 |
| Completed | 20 | 18 |
| Not completed | 0 | 3 |
Colony-forming unit density at incision site (CFU/m3)
| CFU/m^3 | No Device | Air Barrier System Device |
|---|---|---|
| CFU Density | 5.05 (2.45 to 7.65) | 1.55 (1.08 to 2.01) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Device | — | 0/20 (0%) | 0/20 (0%) |
| Air Barrier System Device | — | 0/18 (0%) | 0/18 (0%) |
| Age, Categorical(Participants) | No Device | Air Barrier System Device | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 13 | 28 |
| >=65 years | 5 | 5 | 10 |
| Sex: Female, Male(Participants) | No Device | Air Barrier System Device | Total |
|---|---|---|---|
| Female | 2 | 0 | 2 |
| Male | 18 | 18 | 36 |
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nimbic Systems, LLC