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N/A N=300 Randomized Quadruple-blind Prevention

Air Barrier System for the Prevention of Surgical Site Infection

Surgical Site Infection

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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