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

NCT ID: NCT03972826

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2021-11-09

Brief Summary

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).

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.

Conditions

Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Provodine

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Microdermis Corporation

INDUSTRY

Sponsor Role: collaborator

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Loreen Herwaldt, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1U54CK000448-01

Identifier Type: NIH

Identifier Source: org_study_id

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