N/A
N=300
Air Barrier System for the Prevention of Surgical Site Infection
Surgical Site Infection
Bottom Line
View on ClinicalTrials.gov: NCT01610271 ↗Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Incidence of Implant Infection (Number of Occurrences in Each Arm). — 4; 0 Participants — p=0.067
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Air Barrier System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nimbic Systems, LLC
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Implant Infection (Number of Occurrences in Each Arm). |
4; 0 | 0.067 |
| PRIMARY Comparison of Levels of Airborne CFU Measured at Incision Sites Between the Control and Air Barrier System Groups |
5.3; 2.5 | — |
| PRIMARY Percent of Patients With Implant Surgical Site Infection |
2.7; 0 | — |
| PRIMARY Percent of Patients With Incisional Surgical Site Infection |
2.0; 2.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- This study will recruit adult patients undergoing total hip arthroplasty, lumbar fusion with instrumentation, or femoral-popliteal bypass graft surgical procedures.
Exclusion Criteria
- The presence of any of the following factors will exclude patients from enrollment in the study:
- History of prior prosthesis infection
- Active infection.
Data sourced from ClinicalTrials.gov (NCT01610271). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.