Air Barrier System for the Prevention of Surgical Site Infection
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Hospital |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/5/2019 |
| Start Date: | January 2012 |
| End Date: | April 2015 |
Air Barrier System to Reduce Contamination of Wounds During Surgery
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.
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.
Surgical site infection (SSI) following prosthesis implantation and other invasive procedures
is a serious complication leading to increased mortality, morbidity, and financial cost to
patients and the U.S. healthcare infrastructure. Multiple studies have shown that the primary
source of surgical site bacterial colonization is staphylococci shed from the skin of people
present in the surgical theatre. These bacteria-carrying skin cells are aerosolized into the
environment and deposit into surgical incisions.
The innovations currently pursued in research and industry to combat nosocomial infection
fall primarily into three categories: (1) developing new antimicrobial drugs and agents, (2)
developing antimicrobial coatings for devices, and (3) implementing procedures to reduce the
risk of cross-contamination. Significant resources are being allocated to prevent infections
from developing post-operatively and to mitigate the effects of infection once microorganisms
enter the body. However, there is little development of new technologies that can be employed
in the operating room to prevent the initial intrusion into the surgery site.
All modern surgical theatres utilize some form of air filtration. In a conventional flow
system, air streams mix freely in the room. In an OR designed for laminar flow (LFOR), air
emits from filters and proceeds into the room in relatively coherent streams. The benefit
thought to be achieved by a LFOR, in principle, is that filtered air does not mix with
contaminated air before reaching the surgery area. The difficulty in achieving the desired
results in a LFOR lies in the fact that once the flow pattern enters the room, it is
subjected to a very complex set of dynamics over a significant distance. Air is clean upon
leaving the filter bank, but it enters a space laden with airborne bacteria and particulate
matter shed from people in the OR.
Nimbic Systems has developed a device, the Air Barrier System (ABS), which shields surgical
sites from airborne contaminants in the operating room by creating a localized clean air
field directly adjacent to and surrounding the incision site. The ABS consists of two
components: a Filter and an air Nozzle with attached Hose. The Filter is a nonsterile
reusable component which filters ambient operating room air and forces it through an exit
port on the top of the unit. The Nozzle is attached on top of the incision drape adjacent to
a surgical incision with Velcro® fastening pads. The end of the Hose is plugged into the
Filter's air exit port. Contaminant-free air then flows through the Hose and Nozzle over the
incision site. The ABS maintains this protective envelope of bacteria-free air over a wide
range of patient and incision site geometries, yet the insertion of hands and instruments are
not disrupted by the protective envelope.
The ABS technology was extremely successful at reducing the presence of bacteria and other
colony forming units at incision sites during Phase I study. In a randomized, prospective
clinical study of 36 hip arthroplasty procedures, the ABS reduced the presence of colony
forming units at incision sites by 84% versus ambient operating room levels.
This will be a prospective randomized double-blind pilot trial of the ABS in three surgical
specialty applications (total hip arthroplasty, lumbar laminectomy with instrumentation, and
femoral-popliteal bypass graft). A cohort of 300 recruited patients will be randomly
assigned, at a 1:1 ratio, to either a control group (no ABS) or experimental group (with
ABS). The primary outcome of the trial is the occurrence of SSI by one year after surgery
using the established CDC definitions and classifications of surgical site infection.
Secondary outcomes include (1) measuring levels of colony forming units (CFU) present in the
operating room air during surgical procedures to examine correlations with occurrence of SSI;
(2) examining types of organisms that cause SSI in the two study groups; and (3) surgeon
satisfaction with the ABS device. Patient characteristics and measures of operating room
environment will be collected during surgery, and the patients' surgical sites will be
clinically evaluated following surgery to identify potential superficial or deep SSI up to
one year after surgery. The estimated occurrence of SSI in the control group is 6%, based on
baseline data pertaining to the three studied types of surgery at the Michael E. DeBakey VA
Medical Center. The anticipated rate of SSI in the experimental group is 3%. The proposed
pilot study is designed to detect a clinically relevant reduction (i.e., a 50% reduction,
from 6% to 3%) in the observed rate of SSI in patients who are exposed to the ABS vs. no ABS.
The results of this proposed pilot trial will be used to construct a subsequent pivotal
prospective, randomized, multi-center clinical trial.
is a serious complication leading to increased mortality, morbidity, and financial cost to
patients and the U.S. healthcare infrastructure. Multiple studies have shown that the primary
source of surgical site bacterial colonization is staphylococci shed from the skin of people
present in the surgical theatre. These bacteria-carrying skin cells are aerosolized into the
environment and deposit into surgical incisions.
The innovations currently pursued in research and industry to combat nosocomial infection
fall primarily into three categories: (1) developing new antimicrobial drugs and agents, (2)
developing antimicrobial coatings for devices, and (3) implementing procedures to reduce the
risk of cross-contamination. Significant resources are being allocated to prevent infections
from developing post-operatively and to mitigate the effects of infection once microorganisms
enter the body. However, there is little development of new technologies that can be employed
in the operating room to prevent the initial intrusion into the surgery site.
All modern surgical theatres utilize some form of air filtration. In a conventional flow
system, air streams mix freely in the room. In an OR designed for laminar flow (LFOR), air
emits from filters and proceeds into the room in relatively coherent streams. The benefit
thought to be achieved by a LFOR, in principle, is that filtered air does not mix with
contaminated air before reaching the surgery area. The difficulty in achieving the desired
results in a LFOR lies in the fact that once the flow pattern enters the room, it is
subjected to a very complex set of dynamics over a significant distance. Air is clean upon
leaving the filter bank, but it enters a space laden with airborne bacteria and particulate
matter shed from people in the OR.
Nimbic Systems has developed a device, the Air Barrier System (ABS), which shields surgical
sites from airborne contaminants in the operating room by creating a localized clean air
field directly adjacent to and surrounding the incision site. The ABS consists of two
components: a Filter and an air Nozzle with attached Hose. The Filter is a nonsterile
reusable component which filters ambient operating room air and forces it through an exit
port on the top of the unit. The Nozzle is attached on top of the incision drape adjacent to
a surgical incision with Velcro® fastening pads. The end of the Hose is plugged into the
Filter's air exit port. Contaminant-free air then flows through the Hose and Nozzle over the
incision site. The ABS maintains this protective envelope of bacteria-free air over a wide
range of patient and incision site geometries, yet the insertion of hands and instruments are
not disrupted by the protective envelope.
The ABS technology was extremely successful at reducing the presence of bacteria and other
colony forming units at incision sites during Phase I study. In a randomized, prospective
clinical study of 36 hip arthroplasty procedures, the ABS reduced the presence of colony
forming units at incision sites by 84% versus ambient operating room levels.
This will be a prospective randomized double-blind pilot trial of the ABS in three surgical
specialty applications (total hip arthroplasty, lumbar laminectomy with instrumentation, and
femoral-popliteal bypass graft). A cohort of 300 recruited patients will be randomly
assigned, at a 1:1 ratio, to either a control group (no ABS) or experimental group (with
ABS). The primary outcome of the trial is the occurrence of SSI by one year after surgery
using the established CDC definitions and classifications of surgical site infection.
Secondary outcomes include (1) measuring levels of colony forming units (CFU) present in the
operating room air during surgical procedures to examine correlations with occurrence of SSI;
(2) examining types of organisms that cause SSI in the two study groups; and (3) surgeon
satisfaction with the ABS device. Patient characteristics and measures of operating room
environment will be collected during surgery, and the patients' surgical sites will be
clinically evaluated following surgery to identify potential superficial or deep SSI up to
one year after surgery. The estimated occurrence of SSI in the control group is 6%, based on
baseline data pertaining to the three studied types of surgery at the Michael E. DeBakey VA
Medical Center. The anticipated rate of SSI in the experimental group is 3%. The proposed
pilot study is designed to detect a clinically relevant reduction (i.e., a 50% reduction,
from 6% to 3%) in the observed rate of SSI in patients who are exposed to the ABS vs. no ABS.
The results of this proposed pilot trial will be used to construct a subsequent pivotal
prospective, randomized, multi-center clinical trial.
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:
1. History of prior prosthesis infection
2. Active infection.
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Michael E. Debakey VA Medical Center The Michael E. DeBakey VA Medical Center serves as...
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