NCT01559506

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at below P25 for not_applicable surgery

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1 month until next milestone

Results Posted

Study results publicly available

March 17, 2015

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

3.3 years

First QC Date

March 14, 2012

Results QC Date

February 25, 2015

Last Update Submit

March 16, 2015

Conditions

Surgery

Keywords

CFUsurgery site

Outcome Measures

Primary Outcomes (1)

  • CFU Density

    Colony-forming unit density at incision site (CFU/m3)

    Surgical case CFU density will be determined at up to 1 month from completion of surgical cases

Study Arms (2)

No device

NO INTERVENTION

Subject does not receive ABS system

Air Barrier System device

EXPERIMENTAL

Device is deployed adjacent to the surgery site and activated.

Device: Air Barrier System device

Interventions

Air Barrier System deviceDEVICE

Device is deployed adjacent to the surgery site and activated.

Air Barrier System device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients undergoing lumbar and cervical laminectomy with instrumentation.

You may not qualify if:

  • Active infection
  • Prior prosthesis infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

Results Point of Contact

Title
Sean Self
Organization
Nimbic Systems
self@nimbicsystems.com
281-565-5715

Study Officials

  • Rabih O Darouiche, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

  • Sean Self

    Nimbic Systems

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2012

First Posted

March 21, 2012

Study Start

November 1, 2011

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 17, 2015

Results First Posted

March 17, 2015

Record last verified: 2015-03

Locations

US(1)