Status:
COMPLETED
Hand Hygiene and Hospital Acquired Infections
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
Sage Products, Inc.
Conditions:
Complication of Surgical Procedure
Eligibility:
All Genders
18+ years
Phase:
NA
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 healt...
Detailed Description
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 heal...
Eligibility Criteria
Inclusion
- 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
- 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
- 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.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
3256 Patients enrolled
Trial Details
Trial ID
NCT02252562
Start Date
September 1 2013
End Date
August 1 2015
Last Update
February 18 2019
Active Locations (2)
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1
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
2
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756