Use of Provodine to Protect HCW Hands (Aim II.1)

Epicenters for the Prevention of Healthcare Associated Infections (HAIs) -- Volume of Contamination and Nosocomial Infection Control: Specific Aim II.1

The investigators will assess whether applying Provodine, an FDA-approved hand hygiene product with a long duration of anti-microbial action, to healthcare workers' hands protects against self-contamination during the removal of personal protective equipment (gloves, gowns, etc).

Study Overview

• Status: Terminated
• Conditions: Infection
• Intervention / Treatment: Other: Provodine

Detailed Description

We will perform a two-armed pilot test among 40 front-line healthcare workers (nurses, doctors, respiratory therapists, etc) at the University of Iowa Hospitals and Clinics. Participants will serve as their own controls. First, participants will perform hand hygiene with alcohol-based hand rub as they normally would in clinical practice then don PPE. We, the research team, will contaminate participating healthcare workers' (HCW) PPE with either bacteriophage MS2 (twenty participants) or S. marcescens ATCC 14756 (twenty participants). MS2 preparation and propagation and S. marcescens culture suspensions will each be performed as previously described. The MS2 bacteriophage will be suspended in 0.01 M phosphate-buffered saline and each PPE site will be contaminated with 10^5 plaque-forming units (PFU) of MS2 in 5 drops of 5 μL each. Aliquots of 3 mL of S. marcescens broth suspension (yielding bacterial titers of ~1 X 10^9 CFU/ml) will be applied to each PPE site. Participants will then doff PPE using the Centers for Disease Control's (CDC) recommended protocol. We will sample their hands using the bag broth method. A research assistant will monitor participants as they wash their hands with soap and water then rinse their hands with 70% ethanol. Participants will then apply ProvodineTM to their hands and put on (don) fresh PPE. We will repeat the contamination, doffing, and sampling procedure. For MS2 recovery, we will assay the eluent using the most probable number (MPN) enrichment infectivity assay. For S. marcescens recovery, we will dilute the eluent, plate it, incubate the plates, and count the colonies as described.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must be UIHC healthcare workers (doctors, nurses, etc.)

Exclusion Criteria:

• Known skin sensitivity to povidone iodine or Provodine (TM)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 1; Subjects serve as self-controls. Subjects first perform hand-hygiene with alcohol-based hand rub then doff gloves contaminated with either S. marcescens or MS2 phage and the hands are cultured using a bag-broth method to determine whether the subjects self-contaminated while doffing. Subjects then clean their hands thoroughly, perform hand hygiene with Provodine, then repeat the doffing and culture process.

Other: Provodine; Subjects serve as self-controls. Subjects first perform hand-hygiene with alcohol-based hand rub then doff gloves contaminated with either S. marcescens or MS2 phage and the hands are cultured using a bag-broth method to determine whether the subjects self-contaminated while doffing. Subjects then clean their hands thoroughly, perform hand hygiene with Provodine, then repeat the doffing and culture process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of participants whose hands were colonized after doffing gloves	The percent of participants whose hands were contaminated with either S marcescens or the phage MS2 after doffing gloves when participants did hand hygiene before the trial with an alcohol-based hand rub compared with that when participants had done hand hygiene before the trial with Provodine	30 minutes
Colony-forming units (CFU) or Plaque forming units (PFU) on participants' hands	The number of S. marcescens CFU or MS2 plaque forming units (PFU) on participants hands when they did hand hygiene before the trial with an alcohol-based hand rub compared with when participants had done hand hygiene before the trial with Provodine	30 minutes

Collaborators and Investigators

• Sponsor: University of Iowa
• Collaborators: Centers for Disease Control and Prevention; Microdermis Corporation
• Investigators: Principal Investigator: Loreen Herwaldt, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): November 9, 2021
• Study Completion (Actual): November 9, 2021

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (Actual): June 4, 2019

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: hand hygiene; healthcare worker self-contamination
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 1U54CK000448-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No