Trial Outcomes & Findings for Device to Reduce Surgery Site Contamination

Results Overview

CFU culture counts for samples taken in surgery.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

Ten-minute intervals throughout procedure

Results posted on

2012-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	No Device	Device Deployed
Overall Study STARTED	13	10
Overall Study COMPLETED	13	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Device to Reduce Surgery Site Contamination - Spine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Device n=13 Participants	Device Deployed n=10 Participants	Total n=23 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	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	10 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: Ten-minute intervals throughout procedure

CFU culture counts for samples taken in surgery.

Outcome measures

Outcome measures
Measure	No Device n=13 Participants No device is deployed during surgery	Device Deployed n=10 Participants The ABS device is employed during surgery.
Surgery Site CFU Density	3.08 CFU/m3 Interval 2.44 to 3.72	1.73 CFU/m3 Interval 1.03 to 2.43

Adverse Events

No Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Device Deployed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events