ProvodineTM Decreases Hand Contamination

Hand Hygiene Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04023682
• Other study ID #: 201312709
• Status: Completed
• Phase: Phase 4
• Start date: December 2013
• Est. completion date: November 2014

Study information

• Verified date: July 2021
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hand Hygiene

Intervention

Drug:
• Provodine Hand Sanitizer
Intervention with Provodine

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Sundara Reddy	Microdermis Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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