Hand HygienePhase 4NCT04023682
ProvodineTM Decreases Hand Contamination
A Phase 4 study testing Provodine Hand Sanitizer in people with Hand Hygiene, run by Sundara Reddy at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Hygiene
- What is being tested?
- Provodine Hand Sanitizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Nov 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be an anesthesia provider at The University of Iowa Hospitals and Clinics
Who cannot join
- Are not an anesthesia provider at The University of Iowa Hospitals and Clinics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hand Hygiene
- Being tested
- Provodine Hand Sanitizer
- Keywords
- Hand hygiene, Provodine, Hand contamination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provodine Hand SanitizerDrug
Also called Provodine
Intervention with Provodine
| Study group | Role | What they receive |
|---|---|---|
| Anesthesia Provider hands | Other | 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 Receives: Drug: Provodine Hand Sanitizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Average of 1 day
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study startDec 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hand HygieneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Anesthesia providers will serve as their own controls
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sundara Reddy
- Sponsor type
- University, hospital or other
- Collaborators
- Microdermis Corporation
- Responsible party
- Sponsor-investigator, Sundara Reddy, University of Iowa
- Investigators
- Sundar Durgempudi Tripura, MD, Principal investigator, University of IowaLoreen Herwaldt, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023682
- Sponsor's protocol ID
- 201312709
- Status last verified
- Jul 2021
- First submitted
- 12 Jun 2019
- Last updated
- 2 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposal to Conduct a Study Assessing Whether ProvodineTM Decreases Contamination of Anesthesia Providers' Hands During General Anesthesia Procedures
- ClinicalTrials.gov ID
- NCT04023682
- Acronym / sponsor ID
- 201312709
- Conditions
- Hand Hygiene
- Keywords
- Hand hygiene, Provodine, Hand contamination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Sundara ReddyUniversity, hospital or other
- Collaborators
- Microdermis Corporation
- Study start
- Dec 2013 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 17 Jul 2019 (actual)
- Results
- Posted 2 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Anesthesia providers will serve as their own controls
| Arm | Type | Receives |
|---|---|---|
| Anesthesia Provider hands | Other | Drug: Provodine Hand SanitizerEach 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 |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be an anesthesia provider at The University of Iowa Hospitals and Clinics
Key exclusion criteria (1 listed)
- Are not an anesthesia provider at The University of Iowa Hospitals and Clinics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provodine Hand SanitizerAlso: ProvodineIntervention with Provodine | Drug | Anesthesia Provider hands |
Primary outcome
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).
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.
5 secondary outcomes
Control Phase-Count and Compare the Number of CFU's After the First Case of the Day.
Time frame: Average of 1 day
Interventional Phase-Count and Compare the Number of CFU's After the First Case of the Day.
Time frame: Average of 1 day
Control Phase-Count and Compare the Number of CFU's After the Second Case of the Day.
Time frame: Average of 1 day
Interventional Phase-Count and Compare the Number of CFU's After the Second Case of the Day.
Time frame: Average of 1 day
Number of Providers/Participants Who Acquired a Pathogen or Commensal During the Day.
Time frame: Average of 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sundar Durgempudi Tripura, MD principal investigator
University of Iowa
Loreen Herwaldt, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Provodine Hand Sanitizer in people with Hand Hygiene, run by Sundara Reddy at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control Period-Count the Number of Baseline Colony Forming Units Cultured From Anesthesiologist's Hands (time frame: Average of 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.