Clinical trial NCT01610271: Air Barrier System for the Prevention of Surgical Site Infection
Official title: Air Barrier System to Reduce Contamination of Wounds During Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Keywords: Prevention
Surgical Site Infection
Air Barrier System
Implant Infection
Lead sponsor: Nimbic Systems, LLC
Sponsor class: INDUSTRY
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
name: Baylor College of Medicine
First posted: 2012-06-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

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:

  1. History of prior prosthesis infection
  2. Active infection.

Primary outcomes:
measure: Incidence of Implant Infection (Number of Occurrences in Each Arm).
timeFrame: One year after surgery
measure: Comparison of Levels of Airborne CFU Measured at Incision Sites Between the Control and Air Barrier System Groups
timeFrame: One year post surgery
measure: Percent of Patients With Implant Surgical Site Infection
timeFrame: Within One Year of Surgical Procedure
measure: Percent of Patients With Incisional Surgical Site Infection
timeFrame: Within One Year of Surgical Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Rabih O Darouiche, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Darouiche RO, Green DM, Harrington MA, Ehni BL, Kougias P, Bechara CF, O'Connor DP. Association of Airborne Microorganisms in the Operating Room With Implant Infections: A Randomized Controlled Trial. Infect Control Hosp Epidemiol. 2017 Jan;38(1):3-10. doi: 10.1017/ice.2016.240. Epub 2016 Oct 26.