Hand Hygiene and Hospital Acquired Infections

NCT02252562 | Completed Results DMC

• 1 other identifier: D13081
• Study Type: interventional
• Target: 3,256
• Locations: 1 country
• Sites: 2

Brief Summary

Healthcare-associated infections (HCAIs) and evolving bacterial resistance are major public health concerns that impact all areas of healthcare. Further work is needed to better understand these healthcare issues so that effective preventive measures can be developed. The investigators have developed and validated an experimental model for studying the risk factors for bacterial cross contamination in the surgical operating room. The investigators have confirmed in our previous work that intraoperative bacterial transmission events occur frequently both within and between surgical cases and that these transmission events are linked to 30-day postoperative HCAIs and increased patient mortality. In response, the investigators have implemented various strategies designed to bacterial transmission in the operating room, including anesthesia provider hand hygiene compliance. The investigators' recent work in the intensive care unit suggests that the hand hygiene system the investigators have previously studied could be further optimized. The investigators now propose to evaluate the effectiveness of a multimodal hand hygiene system enhanced with novel wireless technology designed to facilitate real-time group and individual performance feedback. The investigators hypothesize that the use of this system will increase hourly hand decontamination events of anesthesia and circulating nurse providers and reduce 30-day postoperative healthcare-associated infections HCAIs (primary outcome), reduce hospital stay duration, and hospital re-admission rates, and mortality(secondary outcomes).

Conditions

Complication of Surgical Procedure

Keywords

Hand hygiene; Hospital acquired infections (HAI); Healthcare acquired infections (HCAI)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Postoperative Healthcare Acquired Infections

  Patients with a prior infection and/or preexisting decolonization will be included and will be expected to be equally distributed between study groups given the randomized study design. For HCAI analysis, only new infection sites and/or a different organism of infection will be considered a new HCAI, per NHSN definitions.

  30-day after surgery

Secondary Outcomes (3)

• Hospital Re-admission Rates

  Within 30 days of discharge

• Mortality

  Within 30 Days of discharge

• Hospital Duration

  30 days after surgery

Other Outcomes (1)

• Hand Hygiene Events Per Hour Utilizing the Device

  During active OR cases

Study Arms (2)

Standard practice

NO INTERVENTION

Usual intraoperative hand hygiene (standard wall mounted devices and machine and/or cart based dispensers)

Personal hand hygiene device

EXPERIMENTAL

Intraoperative use of personalized body worn alcohol dispensers incorporating a novel wireless tracking system \[(SAGE Products Inc., Cary, Il),

Device: Sage Personal Hand Hygiene System

Interventions

Sage Personal Hand Hygiene System DEVICE

Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback.

Personal hand hygiene device

Eligibility Criteria

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

You may qualify if:

• Operating room environments involving adult patients undergoing general anesthesia, according to usual practice, for elective or urgent and emergent orthopedic, plastic, neurosurgical, cardiothoracic, urological, general abdominal, gynecological, vascular, or ear/nose/and throat surgical procedures
• Requirement of a peripheral and/or central intravenous catheter
• The investigators will \[randomize by the day in order to ensure that the treatment and control arms maintain their integrity and to facilitate an environment conducive to behavior change.\] The investigators anticipate that the randomization strategy will allow equal distribution of urgent and emergent patients in the treatment and control groups. Patients with a prior infection and/or preexisting decolonization will be included and will be expected to be equally distributed between study groups given the randomized study design. For HCAI analysis, only new infection sites and/or a different organism of infection will be considered a new HCAI, per NHSN definitions (see below). The investigators realize that decolonization procedures have the capacity to reduce the effect size, and as such, we have appropriately adjusted the sample size (see statistical section).

You may not qualify if:

• Pediatric patients
• Lack of an intravenous catheter
• Pregnant
• A surgical procedure outside of the classes listed above
• Adjustments on the day of surgery given the following considerations:
• Provider allergy/intolerance to 64% alcohol: In the case where the primary anesthesia provider conveys a prior allergy to 64% alcohol and/or a history of significant contact dermatitis, the operating room will be excluded from enrollment. If a primary anesthesia provider develops an allergy and/or contact dermatitis during the study period, this will be documented, and operating rooms assigned to the primary anesthesia provider for future cases will be excluded. The expectation will be that all key providers working in operating rooms randomized to the intervention will participate in utilization of the device. If an operating room is randomized and a provider subsequently refuses to participate for any reason, the operating room will be excluded from the primary analysis but included in an intention-to-treat analysis. An additional operating room will be randomized for each such occurrence.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Sage Products, Inc.: collaborator

Study Sites (2)

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (3)

• Koff MD, Loftus RW, Burchman CC, Schwartzman JD, Read ME, Henry ES, Beach ML. Reduction in intraoperative bacterial contamination of peripheral intravenous tubing through the use of a novel device. Anesthesiology. 2009 May;110(5):978-85. doi: 10.1097/ALN.0b013e3181a06ec3.

  PMID: 19352154 BACKGROUND

• Loftus RW, Koff MD, Burchman CC, Schwartzman JD, Thorum V, Read ME, Wood TA, Beach ML. Transmission of pathogenic bacterial organisms in the anesthesia work area. Anesthesiology. 2008 Sep;109(3):399-407. doi: 10.1097/ALN.0b013e318182c855.

  PMID: 18719437 BACKGROUND

• Koff MD, Brown JR, Marshall EJ, O'Malley AJ, Jensen JT, Heard SO, Longtine K, O'Neill M, Longtine J, Houston D, Robison C, Moulton E, Patel HM, Loftus RW. Frequency of Hand Decontamination of Intraoperative Providers and Reduction of Postoperative Healthcare-Associated Infections: A Randomized Clinical Trial of a Novel Hand Hygiene System. Infect Control Hosp Epidemiol. 2016 Aug;37(8):888-895. doi: 10.1017/ice.2016.106. Epub 2016 Jun 7.

  PMID: 27267310 RESULT

Results Point of Contact

• Title: Matthew D. Koff, MD Staff Physician, Anesthesiology
• Organization: Dartmouth-Hitchcock Medical Center

Matthew.D.Koff@hitchcock.org

(603) 650-5922

Study Officials

• Stephen O Heard, MD

  UMass Memorial Health

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: September 30, 2014
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: August 1, 2015
• Last Updated: February 18, 2019
• Results First Posted: February 18, 2019

Record last verified: 2019-02

Locations

US (2)