Clinical trial NCT04023682: ProvodineTM Decreases Hand Contamination
Official title: Proposal to Conduct a Study Assessing Whether ProvodineTM Decreases Contamination of Anesthesia Providers' Hands During General Anesthesia Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hand Hygiene
Keywords: Hand hygiene
Provodine
Hand contamination
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Microdermis Corporation
First posted: 2019-07-17
Enrollment: 31
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Anesthesia providers will serve as their own controls
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to see whether Provodine, an FDA approved product, provides long-lasting protection on the hands of staff who provide anesthesia for patients. If this product does provide long-lasting protection, it could be used for hand hygiene in the operating room and it could help prevent infections after operations. Fifteen anesthesia providers (15 main operating room \[MOR\] and 5 ambulatory surgery center \[ASC\]) who agree to participate will participate in the pre-intervention and intervention periods. During the pre-intervention or baseline period, the investigators will do bag broth cultures of anesthesia providers' hands just before the start of their first case of the day . The participants will then rinse and dry their hands to remove the culture medium. The investigators will also obtain cultures after the first case of the day, and after the second case. During the intervention period (ProvodineTM; usual hand hygiene practice), the investigators obtain hand cultures from the same anesthesia providers at the beginning of the day. The participants will then then do a hand scrub with ProvodineTM. The investigators will obtain a second hand culture at this point and participants will rinse and dry their hands to remove the culture medium and then apply a small amount of ProvodineTM as a hand rub. The investigators will obtain cultures after the first case of the day, and after the second case of the day. If participants are still providing anesthesia to their second case 6 hours after they applied ProvodineTM, the participants will apply a small of ProvodineTM amount as a hand rub at this time.

For anesthesia providers in the ASC, the investigators will use the same protocol with the following exception. Because cases are likely to be shorter, the investigators will obtain the final cultures after the last case of the day or after the case that ends closest to 6 hours after ProvodineTM was applied in the morning.

Detailed description: During the pre-intervention or baseline period, the investigators will do bag broth cultures of anesthesia providers' hands just before the start of their first case of the day (n =25). The participants will then rinse and dry their hands to remove the culture medium. The investigators will also obtain cultures after the first case of the day (n = 25), and after the second case (n = 25). During the intervention period (ProvodineTM; usual hand hygiene practice), the investigators obtain hand cultures from the same anesthesia providers at the beginning of the day (n =25). The participants will then then do a hand scrub with ProvodineTM. The investigators will obtain a second hand culture at this point and participants will rinse and dry their hands to remove the culture medium and then apply a small amount of ProvodineTM as a hand rub (n =25). The investigators will obtain cultures after the first case of the day (n = 25), and after the second case of the day (n = 25). If participants are still providing anesthesia to their second case 6 hours after they applied ProvodineTM, the participants will apply a small of ProvodineTM amount as a hand rub at this time. For anesthesia providers in the ASC, the investigators will use the same protocol with the following exception. Because cases are likely to be shorter, the investigators will obtain the final cultures after the last case of the day or after the case that ends closest to 6 hours after ProvodineTM was applied in the morning.

The study procedures will occur on two different work days for the participants: one for the control day and one for the intervention day. The study procedures will be done by the end of these two working days. There is no long-term followup.

Eligibility criteria: Inclusion Criteria:

- Must be an anesthesia provider at The University of Iowa Hospitals and Clinics

Exclusion Criteria:

- Are not an anesthesia provider at The University of Iowa Hospitals and Clinics

Primary outcomes:
measure: Control Period-Count the Number of Baseline Colony Forming Units Cultured From Anesthesiologist's Hands
timeFrame: Average of 1 day
measure: Intervention Period-Count the Number of Baseline Colony Forming Units Cultured From Anesthesiologist's Hands
timeFrame: Average of 1 day
Secondary outcomes:
measure: Control Phase-Count and Compare the Number of CFU's After the First Case of the Day.
timeFrame: Average of 1 day
measure: Interventional Phase-Count and Compare the Number of CFU's After the First Case of the Day.
timeFrame: Average of 1 day
measure: Control Phase-Count and Compare the Number of CFU's After the Second Case of the Day.
timeFrame: Average of 1 day
measure: Interventional Phase-Count and Compare the Number of CFU's After the Second Case of the Day.
timeFrame: Average of 1 day
measure: Number of Providers/Participants Who Acquired a Pathogen or Commensal During the Day.
timeFrame: Average of 1 day
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Sundar Durgempudi Tripura, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Loreen Herwaldt, MD
role: PRINCIPAL_INVESTIGATOR
References: