ProvodineTM Decreases Hand Contamination

Proposal to Conduct a Study Assessing Whether ProvodineTM Decreases Contamination of Anesthesia Providers' Hands During General Anesthesia Procedures

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.

Study Overview

• Status: Completed
• Conditions: Hand Hygiene
• Intervention / Treatment: Drug: Provodine Hand Sanitizer

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Anesthesia Provider hands; Each provider will serve as their own control. Control phase is at baseline using standard hygiene practices. Intervention phase will include the addition of Provodine hand sanitizer	Drug: Provodine Hand Sanitizer; Intervention with Provodine; Other Names: Provodine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Control Period-Count the Number of Baseline Colony Forming Units Cultured From Anesthesiologist's Hands	Each subject of the study will serve as their own controls and a comparison will be made between the control phase of the study and the intervention phase of the study. Control portion of the study-usual hand hygiene practice but prior to the anesthesiologist's first case of the day, bag broth cultures will be obtained and the number of CFU's will be counted (T1).	Average of 1 day
Intervention Period-Count the Number of Baseline Colony Forming Units Cultured From Anesthesiologist's Hands	During the intervention period, a bag broth culture was performed immediately after the anesthesiologist enter the operating suite. Provodine was applied to the participant's hands, rubbed into his/her skin, washed hands, and dried with a sterile towel. After this a second bag broth culture was obtained.	Average of 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Control Phase-Count and Compare the Number of CFU's After the First Case of the Day.	After the first surgical case for the day, a bag broth culture was collected (T2) during the control phase from each individual anesthesia provider.	Average of 1 day
Interventional Phase-Count and Compare the Number of CFU's After the First Case of the Day.	After the first surgical case for the day, a bag broth culture was collected (T2) during the interventional phase from each individual anesthesia provider.	Average of 1 day
Control Phase-Count and Compare the Number of CFU's After the Second Case of the Day.	After the second surgical case for the day, a bag broth culture was collected (T3) during the control phase from each individual anesthesia provider.	Average of 1 day
Interventional Phase-Count and Compare the Number of CFU's After the Second Case of the Day.	After the second surgical case for the day, a bag broth culture was collected (T3) during the interventional phase from each individual anesthesia provider.	Average of 1 day
Number of Providers/Participants Who Acquired a Pathogen or Commensal During the Day.	Participants participated in both the control as well as the interventional phase of this study. The number of unique providers who acquired a pathogen during the course of their day are counted and reported.	Average of 1 day

Collaborators and Investigators

• Sponsor: Sundara Reddy
• Collaborators: Microdermis Corporation
• Investigators: Principal Investigator: Loreen Herwaldt, MD, University of Iowa; Principal Investigator: Sundar Durgempudi Tripura, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 9, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Provodine; Hand hygiene; Hand contamination
• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Hand Sanitizers
• Other Study ID Numbers: 201312709

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes