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OpenTrials
Completed

NCT Number: NCT04023682

ProvodineTM Decreases Hand Contamination

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.

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Key information

Conditions

Hand Hygiene

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Provodine Hand Sanitizer

Drug

Intervention with Provodine

Other names: Provodine

Primary outcomes

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

    Time frame: 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

    Time frame: 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 outcomes

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sundara Reddy

Other

Collaborators

  • Microdermis Corporation

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 17, 2019
Registry last updated
Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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