N/A
N=14,418
Direct Gloving Strategy: A Cluster-randomized Trial
Hand Hygiene
Bottom Line
View on ClinicalTrials.gov: NCT03119389 ↗Enrolled (actual)
14,418
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Number of Participants With Composite Compliance With Expected Infection Prevention Practices Upon Entry to Contact Precaution-patient Rooms — 1297; 954 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Donning Non-Sterile Gloves without HH (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Composite Compliance With Expected Infection Prevention Practices Upon Entry to Contact Precaution-patient Rooms |
1297; 954 | — |
| SECONDARY Proportion of Healthcare Worker Who Use Glove on Entry Into Contact Precaution Rooms |
1297; 1530 | — |
| SECONDARY Proportion of Healthcare Workers Who Perform Hand Hygiene on Entry Into Non-contact Precaution Room |
1111; 951 | — |
| SECONDARY Proportion of Healthcare Worker Who Perform Hand Hygiene on Exit From Any Room |
1525; 1587 | — |
Summary
The necessity of Hand hygiene (HH) before donning non-sterile gloves is unknown. Furthermore, because of the additional time required to cleanse hands and then don gloves, as well as the cumbersome nature of applying gloves to recently washed hands, this practice leads to non-compliance with both HH and glove use - placing patients at risk. In a pilot study, the investigators performed a randomized trial of 230 healthcare workers and demonstrated no difference in total bacterial colony counts or identification of pathogenic bacteria from the gloves of persons who either performed HH or did not perform HH prior to putting on non-sterile gloves. If unnecessary, HH before non-sterile glove use wastes valuable time, which might otherwise be spent engaged in direct patient care. And removing this unnecessary step may lead to increased compliance with infection prevention measures. In Aim A, the investigators will perform a multi-center randomized control trial to evaluate the efficacy of a direct gloving strategy to improve compliance with infection prevention practices. In Aim B, the investigators will perform a nested multi-center validation study, where the gloved hands of healthcare workers will be randomly sampled to determine bacterial contamination of non-sterile gloves after donning.
Eligibility Criteria
For Aim B
Inclusion Criteria
- Health professional at one of the study sites
- Has direct interaction with patients at study sites (healthcare worker)
Exclusion Criteria
- <18 years old
Data sourced from ClinicalTrials.gov (NCT03119389). 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.