Hand Hygiene
Conditions
Keywords
Hand hygiene, Provodine, Hand contamination
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.
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.
Interventions
DRUGProvodine Hand Sanitizer
Intervention with Provodine
Sponsors
Microdermis Corporation
Sundara Reddy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Anesthesia providers will serve as their own controls
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Anesthesia Provider Hands Anesthesia Providers hands cultures with standard hand hygiene
Provodine Hand Sanitizer: Intervention with Provodine | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Clinical schedules did not allow continued participation | 6 |
Baseline characteristics
| Characteristic | Anesthesia Provider Hands |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
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).
Time frame: Average of 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anesthesia Provider Hands | Control Period-Count the Number of Baseline Colony Forming Units Cultured From Anesthesiologist's Hands | 589.3 Colony forming units | Standard Deviation 823.7 |
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.
Time frame: Average of 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anesthesia Provider Hands | Intervention Period-Count the Number of Baseline Colony Forming Units Cultured From Anesthesiologist's Hands | 788.9 Colony forming units | Standard Deviation 1051.3 |
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.
Time frame: Average of 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anesthesia Provider Hands | Control Phase-Count and Compare the Number of CFU's After the First Case of the Day. | 825.2 Colony forming units | Standard Deviation 1299.2 |
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.
Time frame: Average of 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anesthesia Provider Hands | Control Phase-Count and Compare the Number of CFU's After the Second Case of the Day. | 971.2 Colony forming units | Standard Deviation 1998.3 |
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.
Time frame: Average of 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anesthesia Provider Hands | Interventional Phase-Count and Compare the Number of CFU's After the First Case of the Day. | 248.9 Colony forming units | Standard Deviation 709 |
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.
Time frame: Average of 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anesthesia Provider Hands | Interventional Phase-Count and Compare the Number of CFU's After the Second Case of the Day. | 382.2 Colony forming units | Standard Deviation 793.4 |
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.
Time frame: Average of 1 day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anesthesia Provider Hands | Number of Providers/Participants Who Acquired a Pathogen or Commensal During the Day. | Total Number-Unique participants | 11 participants |
| Anesthesia Provider Hands | Number of Providers/Participants Who Acquired a Pathogen or Commensal During the Day. | Pathogens-Control phase | 2 participants |
| Anesthesia Provider Hands | Number of Providers/Participants Who Acquired a Pathogen or Commensal During the Day. | Pathogens-Interventional phase | 3 participants |
| Anesthesia Provider Hands | Number of Providers/Participants Who Acquired a Pathogen or Commensal During the Day. | Commensals-Control phase | 3 participants |
| Anesthesia Provider Hands | Number of Providers/Participants Who Acquired a Pathogen or Commensal During the Day. | Commensals-Interventional phase | 3 participants |