CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 14,418 enrolled
Drug / intervention
Donning Non-Sterile Gloves without HHbehavioral
Likely dose
Education on direct gloving without prior hand hygiene for donning non-sterile glovesAI-extracted
Key inclusion· 1
  • Health professional with direct patient interaction at study sites
Key exclusion· 1
  • Age less than 18 years

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03119389
NCT03119389N/ACompleted

Efficacy of a Direct Gloving Strategy to Improve Compliance With Infection Prevention Practices: A Cluster-randomized Trial

University of Maryland, Baltimore·interventional·Posted Apr 18, 2017·Updated May 19, 2020

In Brief

A clinical study evaluating Donning Non-Sterile Gloves without HH for Hand Hygiene. Completed, enrolled 14,418 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHand Hygiene
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 18, 2017
Enrollment StartJan 1, 2016
Primary CompletionNov 30, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.2 years ago

Interventions

Donning Non-Sterile Gloves without HHbehavioral

Current practice is to perform hand hygiene before donning of non-sterile gloves. In units assigned to the intervention, healthcare workers within the units will be educated that performing hand hygiene before donning non-sterile gloves is not necessary.