Trial Outcomes & Findings for ProvodineTM Decreases Hand Contamination (NCT NCT04023682)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

31 participants

Primary outcome timeframe

Average of 1 day

Results posted on

2021-08-02

Participant Flow

Participant milestones

Participant milestones
Measure	Anesthesia Provider Hands Anesthesia Providers hands cultures with standard hand hygiene Provodine Hand Sanitizer: Intervention with Provodine
Overall Study STARTED	31
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Anesthesia Provider Hands Anesthesia Providers hands cultures with standard hand hygiene Provodine Hand Sanitizer: Intervention with Provodine
Overall Study Clinical schedules did not allow continued participation	6

Baseline Characteristics

ProvodineTM Decreases Hand Contamination

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anesthesia Provider Hands n=31 Participants Anesthesia Providers hands cultures with standard hand hygiene Provodine Hand Sanitizer: Intervention with Provodine
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Anesthesia Provider Hands n=31 Participants Anesthesia Providers hands cultures with standard hand hygiene
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Anesthesia Provider Hands n=25 Participants Anesthesia Providers hands cultures with standard hand hygiene
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Anesthesia Provider Hands n=31 Participants Anesthesia Providers hands cultures with standard hand hygiene
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Anesthesia Provider Hands n=25 Participants Anesthesia Providers hands cultures with standard hand hygiene
Interventional Phase-Count and Compare the Number of CFU's After the First Case of the Day.	248.9 Colony forming units Standard Deviation 709.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Anesthesia Provider Hands n=31 Participants Anesthesia Providers hands cultures with standard hand hygiene
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Anesthesia Provider Hands n=25 Participants Anesthesia Providers hands cultures with standard hand hygiene
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Anesthesia Provider Hands n=31 Participants Anesthesia Providers hands cultures with standard hand hygiene
Number of Providers/Participants Who Acquired a Pathogen or Commensal During the Day. Total Number-Unique participants	11 participants
Number of Providers/Participants Who Acquired a Pathogen or Commensal During the Day. Pathogens-Control phase	2 participants
Number of Providers/Participants Who Acquired a Pathogen or Commensal During the Day. Pathogens-Interventional phase	3 participants
Number of Providers/Participants Who Acquired a Pathogen or Commensal During the Day. Commensals-Control phase	3 participants
Number of Providers/Participants Who Acquired a Pathogen or Commensal During the Day. Commensals-Interventional phase	3 participants

Adverse Events

Anesthesia Provider Hands

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sundara Reddy, MBBS

University of Iowa Hospitals and Clinics

Phone: (319) 356-2108

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place