Air Barrier System for the Prevention of Surgical Site Infection
Completed · Not applicable
Conditions studied: Surgical Site Infection
In brief
Airborne particles are present in all indoor environments including the operating room. Most of these particles come from the surgical staff moving around in the room, positioning of the patient during surgery, and the movement of surgical equipment and supplies. While the amount of particulate in an operating room is much, much less than is found in a typical home or public space, some particulate is usually present no matter how the room and air are cleaned and filtered. Typically these few particulate cause no problems, but the goal is always to have the cleanest air possible during surgery. The Air Barrier System (ABS) consists of a reusable blower and a sterile nozzle. The blower feeds filtered air into the sterile disposable nozzle, which disperses a constant stream of gentle, high purity air over the surgical incision. This stream of air forms a shield over the surgical area to prevent airborne particulate from settling into the open wound. This is particularly critical for long-duration surgeries, such as procedures that involve the implantation of a prosthesis. The main objective of this research study is to determine whether the ABS can reduce the potential for surgical site infection during total hip replacement, spinal fusion, or lower extremity bypass grafting procedures. These procedures were chosen because each is a long-duration procedure which involves implantation of prosthesis.
Key facts
- Study ID
- NCT01610271
- Run by
- Nimbic Systems, LLC
- People needed
- 300
- Starts
- 2012-01-01
- Expected to finish
- 2015-04-01
- Last updated by the study team
- 2019-01-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- This study will recruit adult patients undergoing total hip arthroplasty, lumbar fusion with instrumentation, or femoral-popliteal bypass graft surgical procedures.
You may not qualify if…
- The presence of any of the following factors will exclude patients from enrollment in the study:
- History of prior prosthesis infection
- Active infection.
Where it is running
- Michael E. DeBakey VA Medical Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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