NCT01594580

Brief Summary

This study will test if nurses wearing scrubs treated with an antimicrobial agent while performing patient care will: \- Decrease the amount of bacterial contamination on scrubs at the end of a typical hospital shift during routine use after home laundering This study will gather information by obtaining swabs from scrubs treated with an antimicrobial and from non-treated scrubs.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

8 months

First QC Date

May 7, 2012

Last Update Submit

July 20, 2023

Conditions

Bacterial Contamination

Outcome Measures

Primary Outcomes (1)

  • Bacterial contamination of scrubs

    Contamination will be defined as: * A swab that is determined to be positive for any of Staphylococcus aureus, Enterococcus species, or Gram-negative bacteria after a hospital shift.

    Outcome will be assessed at the end of the hospital shift ( approx 8 hours)

Study Arms (2)

Antimicrobial impregnated scrubs

EXPERIMENTAL

Those randomized to this arm of the study will wear scrubs impregnated with an antimicrobial.

Other: Antimicrobial impregnated scrubs

Non-impregnated scrubs

PLACEBO COMPARATOR

Those randomized to this arm of the study will wear scrubs not impregnated with an antimicrobial.

Other: Non-impregnated scrubs

Interventions

Antimicrobial impregnated scrubsOTHER

Scrubs are impregnated with an antimicrobial product

Antimicrobial impregnated scrubs
Non-impregnated scrubsOTHER
Non-impregnated scrubs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nursing staff engaging in direct patient care
  • Working in select/participating intensive care and intermediate care units
  • Working at least 8 day shifts in one month (study period)

You may not qualify if:

  • Pregnant
  • Unable to provide consent
  • Unable to follow study schedule

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • J Kristie Johnson, PhD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 7, 2012

First Posted

May 9, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 21, 2023

Record last verified: 2023-07