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NCT01610271 · ClinicalTrials.gov registry record · NA
Air Barrier System for the Prevention of Surgical Site Infection
A NA study of Surgical Site Infection, sponsored by Nimbic Systems.
- Completed
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 1
- Study location
NCT01610271: Completed NA study of Surgical Site Infection, sponsored by Nimbic Systems.
NCT01610271 is a NA study of Surgical Site Infection that has completed, run by Nimbic Systems. The registered enrollment target is 300 participants, below the 556-participant average among 25 other Surgical Site Infection trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01610271, a NA study of Surgical Site Infection, has completed, sponsored by Nimbic Systems.
- COMPLETED
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Fewer patients in the Air Barrier System group will have implant infection compared to the Control group. Diagnosis of SSI was made by a physician who was masked to the patients' group assignment and not involved in the patients' care by evaluating medical records using the standard and extremely widely used (clinically, epidemiologically, and in research) CDC criteria\*, which categorize SSI into superficial incisional, deep incisional, and organ/space/implant levels. Superficial and deep incis
Conditions Studied
Interventions
- DEVICE Air Barrier System
Study Locations (1)
Texas
- Michael E. DeBakey VA Medical Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2012-01 |
| Est. Completion | 2015-04 |
| Phase | NA |
What the finished NCT01610271 record still lists
NCT01610271 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 556-participant average among 25 other Surgical Site Infection trials with a reported enrollment target (46% lower).
The record links to 1 condition, with Surgical Site Infection appearing as the primary indexed condition, and to 1 intervention - of which Air Barrier System is the first listed.
NCT01610271 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01610271 about?
NCT01610271 is a clinical study titled "Air Barrier System for the Prevention of Surgical Site Infection". 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 a...
What is the current status of trial NCT01610271?
This trial is currently completed. It is a NA study. The enrollment target is 300 participants. The study started on 2012-01. Estimated completion is 2015-04.
What conditions does trial NCT01610271 study?
This clinical trial studies the following conditions: Surgical Site Infection.
What interventions are being tested in trial NCT01610271?
The interventions under investigation include: Air Barrier System (DEVICE).
Who is sponsoring clinical trial NCT01610271?
This trial is sponsored by Nimbic Systems, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01610271 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01610271's enrollment target sits among peer trials
300 12th of 25 higher than 14 of 25 other Surgical Site Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Surgical Site Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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