Hand Hygiene and Hospital Acquired Infections
Complication of Surgical Procedure
Bottom Line
View on ClinicalTrials.gov: NCT02252562 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sage Personal Hand Hygiene System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Postoperative Healthcare Acquired Infections |
108; 116 | — |
| SECONDARY Hospital Re-admission Rates |
— | — |
| SECONDARY Mortality |
6; 7 | — |
| SECONDARY Hospital Duration |
— | — |
Summary
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02252562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.