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

NCT03972826 | Terminated

• 1 other identifier: 1U54CK000448-01
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Infection

Keywords

hand hygiene; healthcare worker self-contamination

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

1

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.

Other: Provodine

Interventions

Provodine 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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Iowa: lead
• Centers for Disease Control and Prevention: collaborator
• Microdermis Corporation: collaborator

MeSH Terms

Conditions

Infections

Study Officials

• Loreen Herwaldt, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 4, 2019
• Study Start: January 1, 2016
• Primary Completion: November 9, 2021
• Study Completion: November 9, 2021
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share