Clinical trial NCT03972826: Use of Provodine to Protect HCW Hands (Aim II.1)
Official title: Epicenters for the Prevention of Healthcare Associated Infections (HAIs) -- Volume of Contamination and Nosocomial Infection Control: Specific Aim II.1
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infection
Keywords: hand hygiene
healthcare worker self-contamination
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Microdermis Corporation
First posted: 2019-06-04
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Percent of participants whose hands were colonized after doffing gloves
timeFrame: 30 minutes
measure: Colony-forming units (CFU) or Plaque forming units (PFU) on participants' hands
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Loreen Herwaldt, MD
role: PRINCIPAL_INVESTIGATOR
References: