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ProvodineTM Decreases Hand Contamination

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ClinicalTrials.gov Identifier: NCT04023682
Recruitment Status : Completed
First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
Microdermis Corporation
Information provided by (Responsible Party):
Sundara Reddy, University of Iowa

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Anesthesia 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 : December 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anesthesia Provider hands
Anesthesia Providers hands cultures with standard hand hygiene
Drug: Provodine Hand Sanitizer
Intervention with Provodine




Primary Outcome Measures :
  1. Title: Compare the number of CFU's (colony forming units) at baseline to intervention phase. [ Time Frame: Up to 3 months ]

    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).

    Interventional phase of the study-usual hand hygiene and bag broth culture collection (T1) followed with a hand scrub using ProvodineTM. A second bag broth culture is collected (T1a).



Secondary Outcome Measures :
  1. : Count and compare the number of CFU's after the first case of the day. [ Time Frame: Up to 3 months ]
    A bag broth culture will be collected after the first case of each day (T2) for both the control phase and interventional phase of the study. The CFU's counted will be compared to their respective T1 or T1a sample.

  2. : Count and compare the number of CFU's after the second case of the day. [ Time Frame: Up to 3 months ]
    A bag broth culture will be collected after the second case of each day (T3) for both the control phase and interventional phase of the study. The CFU's counted will be compared to their respective T1 or T1a sample.

  3. : Microbiology of hand cultures [ Time Frame: Up to 3 months ]
    Compute the number of pathogens found on the provider's hands

  4. : Providers who acquired a pathogen, commensal or both during the day. [ Time Frame: Up to 3 months ]
    Calculate the number of providers who acquired a pathogen during the course of their day.

  5. Providers who eliminated a pathogen after using Providine TM [ Time Frame: Up to 3 months ]
    Calculate the number of providers who eliminated a pathogen during the course of their day after the use of Providine TM.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04023682


Locations
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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Sundara Reddy
Microdermis Corporation
Investigators
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Principal Investigator: Sundar Durgempudi Tripura, MD University of Iowa
Principal Investigator: Loreen Herwaldt, MD University of Iowa

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Responsible Party: Sundara Reddy, Clinical Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT04023682     History of Changes
Other Study ID Numbers: 201312709
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, University of Iowa:
Hand hygiene
Provodine
Hand contamination

Additional relevant MeSH terms:
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Anesthetics
Hand Sanitizers
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants