ProvodineTM Decreases Hand Contamination

• Sponsor: Sundara Reddy (Other)
• Overall Status: Completed
• CT.gov ID: NCT04023682
• Collaborator: Microdermis Corporation (Industry)
• Enrollment: 31
• Location: 1
• Arm: 1
• Actual Duration (Months): 11
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hand Hygiene	Drug: Provodine Hand Sanitizer	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Anesthesia providers will serve as their own controlsAnesthesia providers will serve as their own controls
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Proposal to Conduct a Study Assessing Whether ProvodineTM Decreases Contamination of Anesthesia Providers' Hands During General Anesthesia Procedures
• Actual Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Control Period-Count the Number of Baseline Colony Forming Units Cultured From Anesthesiologist's Hands [Average of 1 day]

   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).

2. Intervention Period-Count the Number of Baseline Colony Forming Units Cultured From Anesthesiologist's Hands [Average of 1 day]

   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.

Secondary Outcome Measures

1. Control Phase-Count and Compare the Number of CFU's After the First Case of the Day. [Average of 1 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.

2. Interventional Phase-Count and Compare the Number of CFU's After the First Case of the Day. [Average of 1 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.

3. Control Phase-Count and Compare the Number of CFU's After the Second Case of the Day. [Average of 1 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.

4. Interventional Phase-Count and Compare the Number of CFU's After the Second Case of the Day. [Average of 1 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.

5. Number of Providers/Participants Who Acquired a Pathogen or Commensal During the Day. [Average of 1 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa	Iowa City	Iowa	United States	52242

Sponsors and Collaborators

• Sundara Reddy
• Microdermis Corporation

Investigators

• Principal Investigator: Sundar Durgempudi Tripura, MD, University of Iowa
• Principal Investigator: Loreen Herwaldt, MD, University of Iowa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sundara Reddy, Clinical Associate Professor, University of Iowa
• ClinicalTrials.gov Identifier: NCT04023682
• Other Study ID Numbers: 201312709
• First Posted: Jul 17, 2019
• Last Update Posted: Aug 2, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Sundara Reddy, Clinical Associate Professor, University of Iowa: Hand hygiene; Provodine; Hand contamination
• Additional relevant MeSH terms: Hand Sanitizers

Study Results

Participant Flow

Arm/Group Title	Anesthesia Provider Hands
Arm/Group Description	Anesthesia Providers hands cultures with standard hand hygiene Provodine Hand Sanitizer: Intervention with Provodine
Period Title: Overall Study
STARTED	31
COMPLETED	25
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Anesthesia Provider Hands
Arm/Group Description	Anesthesia Providers hands cultures with standard hand hygiene Provodine Hand Sanitizer: Intervention with Provodine
Overall Participants	31
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	31 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	11 35.5%
Male	20 64.5%
Region of Enrollment (participants) [Number]
United States	31 100%

Outcome Measures

1. Primary Outcome

Title	Control Period-Count the Number of Baseline Colony Forming Units Cultured From Anesthesiologist's Hands
Description	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).
Time Frame	Average of 1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anesthesia Provider Hands
Arm/Group Description	Anesthesia Providers hands cultures with standard hand hygiene
Measure Participants	31
Mean (Standard Deviation) [Colony forming units]	589.3 (823.7)

2. Primary Outcome

Title	Intervention Period-Count the Number of Baseline Colony Forming Units Cultured From Anesthesiologist's Hands
Description	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.
Time Frame	Average of 1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anesthesia Provider Hands
Arm/Group Description	Anesthesia Providers hands cultures after use with Provodine hand sanitizer. Provodine Hand Sanitizer: Intervention with Provodine
Measure Participants	25
Mean (Standard Deviation) [Colony forming units]	788.9 (1051.3)

3. Secondary Outcome

Title	Control Phase-Count and Compare the Number of CFU's After the First Case of the Day.
Description	After the first surgical case for the day, a bag broth culture was collected (T2) during the control phase from each individual anesthesia provider.
Time Frame	Average of 1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anesthesia Provider Hands
Arm/Group Description	Anesthesia Providers hands cultures with standard hand hygiene Provodine Hand Sanitizer: Intervention with Provodine
Measure Participants	31
Mean (Standard Deviation) [Colony forming units]	825.2 (1299.2)

4. Secondary Outcome

Title	Interventional Phase-Count and Compare the Number of CFU's After the First Case of the Day.
Description	After the first surgical case for the day, a bag broth culture was collected (T2) during the interventional phase from each individual anesthesia provider.
Time Frame	Average of 1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anesthesia Provider Hands
Arm/Group Description	Anesthesia Providers hands cultures after use with Provodine hand sanitizer.
Measure Participants	25
Mean (Standard Deviation) [Colony forming units]	248.9 (709.0)

5. Secondary Outcome

Title	Control Phase-Count and Compare the Number of CFU's After the Second Case of the Day.
Description	After the second surgical case for the day, a bag broth culture was collected (T3) during the control phase from each individual anesthesia provider.
Time Frame	Average of 1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anesthesia Provider Hands
Arm/Group Description	Anesthesia Providers hands cultures with standard hand hygiene Provodine Hand Sanitizer: Intervention with Provodine
Measure Participants	31
Mean (Standard Deviation) [Colony forming units]	971.2 (1998.3)

6. Secondary Outcome

Title	Interventional Phase-Count and Compare the Number of CFU's After the Second Case of the Day.
Description	After the second surgical case for the day, a bag broth culture was collected (T3) during the interventional phase from each individual anesthesia provider.
Time Frame	Average of 1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anesthesia Provider Hands
Arm/Group Description	Anesthesia Providers hands cultures after use with Provodine hand sanitizer.
Measure Participants	25
Mean (Standard Deviation) [Colony forming units]	382.2 (793.4)

7. Secondary Outcome

Title	Number of Providers/Participants Who Acquired a Pathogen or Commensal During the Day.
Description	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.
Time Frame	Average of 1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anesthesia Provider Hands
Arm/Group Description	Anesthesia Providers hands cultures
Measure Participants	31
Total Number-Unique participants	11 35.5%
Pathogens-Control phase	2 6.5%
Pathogens-Interventional phase	3 9.7%
Commensals-Control phase	3 9.7%
Commensals-Interventional phase	3 9.7%

Adverse Events

Arm/Group Title	Anesthesia Provider Hands
Arm/Group Description	Anesthesia Providers hands cultures with standard hand hygiene Provodine Hand Sanitizer: Intervention with Provodine
All Cause Mortality
	Anesthesia Provider Hands
	Affected / at Risk (%)	# Events
Total	0/31 (0%)
Serious Adverse Events
	Anesthesia Provider Hands
	Affected / at Risk (%)	# Events
Total	0/31 (0%)
Other (Not Including Serious) Adverse Events
	Anesthesia Provider Hands
	Affected / at Risk (%)	# Events
Total	0/31 (0%)

Limitations/Caveats

The number of days that elapsed between the control phase and the interventional phase from each individual provider who completed both phases ranged from 1 day to 83 days. In the control phase, 31 providers participated (20 male, 11 female). Six providers withdrew and did not complete the interventional phase (3 male, 3 female).

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.