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| Name | Class |
|---|---|
| Microdermis Corporation | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provodine Hand Sanitizer | Drug | Intervention with Provodine |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Interventional Phase-Count and Compare the Number of CFU's After the First Case of the Day. |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Sundar Durgempudi Tripura, MD | University of Iowa | Principal Investigator |
| Loreen Herwaldt, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anesthesia Provider Hands | Anesthesia Providers hands cultures with standard hand hygiene Provodine Hand Sanitizer: Intervention with Provodine |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Anesthesia Provider Hands | Anesthesia Providers hands cultures with standard hand hygiene Provodine Hand Sanitizer: Intervention with Provodine |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | Colony forming units | Average of 1 day |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anesthesia Provider Hands | Anesthesia Providers hands cultures with standard hand hygiene Provodine Hand Sanitizer: Intervention with Provodine |
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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).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sundara Reddy, MBBS | University of Iowa Hospitals and Clinics | (319) 356-2108 | sundarareddy-durgempuditripura@uiowa.edu |
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Anesthesia providers will serve as their own controls
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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 |
| 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 |
| 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 |
| 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 |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| 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. | Posted | Mean | Standard Deviation | Colony forming units | Average of 1 day |
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| 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. | Posted | Mean | Standard Deviation | Colony forming units | Average of 1 day |
|
|
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| 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. | Posted | Mean | Standard Deviation | Colony forming units | Average of 1 day |
|
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| 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. | Posted | Mean | Standard Deviation | Colony forming units | Average of 1 day |
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| 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. | Posted | Mean | Standard Deviation | Colony forming units | Average of 1 day |
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| 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. | Posted | Number | participants | Average of 1 day |
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| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
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| Commensals-Control phase |
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| Commensals-Interventional phase |
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