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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03972826
• Other study ID #: 1U54CK000448-01
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: November 9, 2021

Study information

• Verified date: November 2022
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: November 9, 2021
• Est. primary completion date: November 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Infection
• Infections

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Iowa	Centers for Disease Control and Prevention, Microdermis Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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