Air Barrier System for the Prevention of Surgical Site Infection

NCT01610271 | Completed Results DMC

• 2 other identifiers: H-281312R44GM095005-02A1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Keywords

Prevention; Surgical Site Infection; Air Barrier System; Implant Infection

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Within One Year of Surgical Procedure

Study Arms (2)

Air Barrier System

EXPERIMENTAL

The Air Barrier System will be employed throughout the surgical procedure for this group of patients.

Device: Air Barrier System

Control

NO INTERVENTION

The Air Barrier System will not be used during the surgical procedure for this group of patients.

Interventions

Air Barrier System DEVICE

ABS is a device that emits a stream of purified air over the surgical site creating a barrier that prevents the intrusion of bacteria.

Also known as: ABS

Air Barrier System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• This study will recruit adult patients undergoing total hip arthroplasty, lumbar fusion with instrumentation, or femoral-popliteal bypass graft surgical procedures.

You may not qualify if:

• The presence of any of the following factors will exclude patients from enrollment in the study:
• History of prior prosthesis infection
• Active infection.

Sponsors & Collaborators

• Nimbic Systems, LLC: lead
• National Institute of General Medical Sciences (NIGMS): collaborator
• Baylor College of Medicine: collaborator

Study Sites (1)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 27780479 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Rabih Darouiche, MD
• Organization: Baylor College of Medicine

sdself@gmail.com

713.799.5088

Study Officials

• Rabih O Darouiche, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: June 4, 2012
• Study Start: January 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: January 3, 2019
• Results First Posted: December 12, 2018

Record last verified: 2018-12

Locations

US (1)