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N/A Completed N=14,418 Randomized Prevention

Direct Gloving Strategy: A Cluster-randomized Trial

Hand Hygiene
Source: ClinicalTrials.gov NCT03119389 ↗
Enrolled (actual)
14,418
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Number of Participants With Composite Compliance With Expected Infection Prevention Practices Upon Entry to Contact Precaution-patient Rooms — 1297; 954 Participants

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.

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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