Device to Reduce Surgery Site Contamination - Spine

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Nimbic Systems, LLC

ClinicalTrials.gov Identifier:

NCT01262105

First received: December 15, 2010

Last updated: April 9, 2012

Last verified: April 2012

Results First Received: March 14, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Outcomes Assessor); Primary Purpose: Basic Science
Condition:	Surgery
Intervention:	Device: Air Barrier System Device

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
No Device	No text entered.
Device Deployed	No text entered.

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
No Device	No text entered.
Device Deployed	No text entered.
Total	Total of all reporting groups

Baseline Measures

	No Device	Device Deployed	Total
Number of Participants [units: participants]	13	10	23
Age [units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	8	7	15
>=65 years	5	3	8
Gender [units: Participants]
Female	7	5	12
Male	6	5	11
Region of Enrollment [units: participants]
United States	13	10	23

Outcome Measures

1. Primary:

Surgery Site CFU Density [ Time Frame: Ten-minute intervals throughout procedure ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Sean Self
Organization: Nimbic Systems
phone: 281-565-5700
e-mail: self@nimbicsystems.com

Publications:

Responsible Party:	Nimbic Systems, LLC
ClinicalTrials.gov Identifier:	NCT01262105 History of Changes
Other Study ID Numbers:	ABS-002
Study First Received:	December 15, 2010
Results First Received:	March 14, 2012
Last Updated:	April 9, 2012
Health Authority:	United States: Institutional Review Board