Trial Outcomes & Findings for Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery (NCT NCT01559506)
NCT ID: NCT01559506
Last Updated: 2015-03-17
Results Overview
Colony-forming unit density at incision site (CFU/m3)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Surgical case CFU density will be determined at up to 1 month from completion of surgical cases
Results posted on
2015-03-17
Participant Flow
Participant milestones
| Measure |
No Device
Subject does not receive ABS system
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
|
Overall Study
COMPLETED
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery
Baseline characteristics by cohort
| Measure |
No Device
n=20 Participants
Subject does not receive ABS system
|
Air Barrier System Device
n=18 Participants
Device is deployed adjacent to the surgery site and activated.
Air Barrier System device: Device is deployed adjacent to the surgery site and activated.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Surgical case CFU density will be determined at up to 1 month from completion of surgical casesColony-forming unit density at incision site (CFU/m3)
Outcome measures
| Measure |
No Device
n=20 Participants
Subject does not receive ABS system
|
Air Barrier System Device
n=18 Participants
Device is deployed adjacent to the surgery site and activated.
Air Barrier System device: Device is deployed adjacent to the surgery site and activated.
|
|---|---|---|
|
CFU Density
|
5.05 CFU/m^3
Interval 2.45 to 7.65
|
1.55 CFU/m^3
Interval 1.08 to 2.01
|
Adverse Events
No Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Air Barrier System Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place