Hand Hygiene and Hospital Acquired Infections



Status:Completed
Conditions:Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:2/20/2019
Start Date:September 2013
End Date:August 2015

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Reduction in 30-Day Postoperative Healthcare-Associated Infections Through Use of a Novel Hand Hygiene System

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).

Healthcare-associated infections (HCAIs) and evolving bacterial resistance are major public
health concerns that impact all healthcare arenas. Further work is indicated to better
understand these healthcare issues in order that effective preventive measures can be
developed.

The investigators have developed and validated an experimental model for studying the
mechanisms, risk factors for, and implications of bacterial cross contamination in the
surgical operating room. The investigators have confirmed through use of this model that
intraoperative bacterial transmission events occur frequently within and between operative
cases and that these transmission events are linked to 30-day postoperative HCAIs and to
increased patient mortality. In response, the investigators have implemented and evaluated
various strategies designed to target risk factors for intraoperative bacterial transmission
events including anesthesia provider hand hygiene compliance, improved handling and design of
intravascular catheters, and improved environmental decontamination of high-risk objects.
While these focused strategies have been successful in reducing transmission events and the
incidence of 30-day postoperative infections, the investigators' recent work in the intensive
care unit suggests that the hand hygiene system the investigators 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, two evidence-based educational interventions, in
reducing 30-day postoperative HCAIs (primary outcome) and intraoperative bacterial
transmission events, hospital stay duration, and hospital re-admission rates (secondary
outcomes).

Inclusion Criteria:

1. 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

2. Requirement of a peripheral and/or central intravenous catheter

Surgical inclusion procedures were selected because they captured the majority of 30-day
postoperative infections in a prior multi-center study that we conducted across three major
academic medical centers [3].

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).

Exclusion Criteria:

1. Pediatric patients

2. Lack of an intravenous catheter

3. Pregnant

4. A surgical procedure outside of the classes listed above

5. 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.
We found this trial at
2
sites
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
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