Surgical Site InfectionABSNCT01610271
Air Barrier System for the Prevention of Surgical Site Infection
A study testing Air Barrier System in people with Surgical Site Infection, run by Nimbic Systems, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Air Barrier System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- This study will recruit adult patients undergoing total hip arthroplasty, lumbar fusion with instrumentation, or femoral-popliteal bypass graft surgical procedures.
Who cannot join
- The presence of any of the following factors will exclude patients from enrollment in the study:
- History of prior prosthesis infection
- Active infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgical Site Infection
- Being tested
- Air Barrier System
- Keywords
- Prevention, Surgical Site Infection, Air Barrier System, Implant Infection
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air Barrier SystemDevice
Also called ABS
ABS is a device that emits a stream of purified air over the surgical site creating a barrier that prevents the intrusion of bacteria.
| Study group | Role | What they receive |
|---|---|---|
| Air Barrier System | Experimental | The Air Barrier System will be employed throughout the surgical procedure for this group of patients. Receives: Device: Air Barrier System |
| Control | No intervention | The Air Barrier System will not be used during the surgical procedure for this group of patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Implant Infection (Number of Occurrences in Each Arm).
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 incisional infections were defined and reported as "incisional" infections, whereas organ/space/implant level infections were defined and reported as "implant" infections.
*See Mangram AJ, et al. Guideline for prevention of surgical site infection, 1999: Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol 1999;20:250-278.
Measured: One year after surgery
Comparison of Levels of Airborne CFU Measured at Incision Sites Between the Control and Air Barrier System Groups
Airborne CFU samplers will be used to monitor bacterial populations at the location immediately adjacent to the surgical site. Air will be drawn through a length of PVC tubing onto agar plates at ten minute intervals. Plates will be incubated for 36 hours at 35 degrees Celsius. Staining and morphological identification will be used to identify and count viable bacteria.
Measured: One year post surgery
Percent of Patients With Implant Surgical Site Infection
Patient will be clinically evaluated to identify potential implant SSI through daily visits during the hospital stay, at subsequent clinic visits and hospital stays, or telephonically on a monthly basis for one year. If encounter indicates the potential presence of SSI, physician will make diagnosis of SSI using the CDC criteria. Organ/space/implant level infections were defined and reported as "implant" infections.
Measured: Within One Year of Surgical Procedure
Percent of Patients With Incisional Surgical Site Infection
Patient will be clinically evaluated to identify potential incisional SSI through daily visits during the hospital stay, at subsequent clinic visits and hospital stays, or telephonically on a monthly basis for one year. If encounter indicates the potential presence of SSI, physician will make diagnosis of SSI using the CDC criteria. Superficial and deep incisional infections were defined and reported as "incisional" infections.
Measured: Within One Year of Surgical Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nimbic Systems, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of General Medical Sciences (NIGMS), Baylor College of Medicine
- Responsible party
- Sponsor
- Investigators
- Rabih O Darouiche, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610271
- Sponsor's protocol ID
- H-28131
- Other IDs
- 2R44GM095005-02A1
- Acronym
- ABS
- Status last verified
- Dec 2018
- First submitted
- 3 May 2012
- Last updated
- 3 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Not determined at this time.
Publications
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.
PubMed 27780479
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air Barrier System to Reduce Contamination of Wounds During Surgery
- ClinicalTrials.gov ID
- NCT01610271
- Acronym / sponsor ID
- ABS / H-28131
- Conditions
- Surgical Site Infection
- Keywords
- Prevention, Surgical Site Infection, Air Barrier System, Implant Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Nimbic Systems, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of General Medical Sciences (NIGMS), Baylor College of Medicine
- Study start
- Jan 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 4 Jun 2012 (estimated)
- Results
- Posted 12 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air Barrier System | Experimental | Device: Air Barrier SystemThe Air Barrier System will be employed throughout the surgical procedure for this group of patients. |
| Control | No intervention | –The Air Barrier System will not be used during the surgical procedure for this group of patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- This study will recruit adult patients undergoing total hip arthroplasty, lumbar fusion with instrumentation, or femoral-popliteal bypass graft surgical procedures.
Key exclusion criteria (3 listed)
- The presence of any of the following factors will exclude patients from enrollment in the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air Barrier SystemAlso: ABSABS is a device that emits a stream of purified air over the surgical site creating a barrier that prevents the intrusion of bacteria. | Device | Air Barrier System |
Primary outcome
Incidence of Implant Infection (Number of Occurrences in Each Arm).
Time frame: One year after surgery
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 incisional infections were defined and reported as "incisional" infections, whereas organ/space/implant level infections were defined and reported as "implant" infections. *See Mangram AJ, et al. Guideline for prevention of surgical site infection, 1999: Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol 1999;20:250-278.
Comparison of Levels of Airborne CFU Measured at Incision Sites Between the Control and Air Barrier System Groups
Time frame: One year post surgery
Airborne CFU samplers will be used to monitor bacterial populations at the location immediately adjacent to the surgical site. Air will be drawn through a length of PVC tubing onto agar plates at ten minute intervals. Plates will be incubated for 36 hours at 35 degrees Celsius. Staining and morphological identification will be used to identify and count viable bacteria.
Percent of Patients With Implant Surgical Site Infection
Time frame: Within One Year of Surgical Procedure
Patient will be clinically evaluated to identify potential implant SSI through daily visits during the hospital stay, at subsequent clinic visits and hospital stays, or telephonically on a monthly basis for one year. If encounter indicates the potential presence of SSI, physician will make diagnosis of SSI using the CDC criteria. Organ/space/implant level infections were defined and reported as "implant" infections.
Percent of Patients With Incisional Surgical Site Infection
Time frame: Within One Year of Surgical Procedure
Patient will be clinically evaluated to identify potential incisional SSI through daily visits during the hospital stay, at subsequent clinic visits and hospital stays, or telephonically on a monthly basis for one year. If encounter indicates the potential presence of SSI, physician will make diagnosis of SSI using the CDC criteria. Superficial and deep incisional infections were defined and reported as "incisional" infections.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27780479Darouiche 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.
- Individual participant dataSharing planned: Undecided. Not determined at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabih O Darouiche, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air Barrier System in people with Surgical Site Infection, run by Nimbic Systems, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Implant Infection (Number of Occurrences in Each Arm). (time frame: One year after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01610271, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019.