ProvodineTM Decreases Hand Contamination

NCT04023682 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 201312709
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Hygiene

Keywords

Hand hygiene; Provodine; Hand contamination

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

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

  Average of 1 day

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

  Average of 1 day

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

  Average of 1 day

• Interventional Phase-Count and Compare the Number of CFU's After the Second Case of the Day.

  Average of 1 day

• Number of Providers/Participants Who Acquired a Pathogen or Commensal During the Day.

  Average of 1 day

Study Arms (1)

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

Drug: Provodine Hand Sanitizer

Interventions

Provodine Hand Sanitizer DRUG

Intervention with Provodine

Also known as: Provodine

Anesthesia Provider hands

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Must be an anesthesia provider at The University of Iowa Hospitals and Clinics

You may not qualify if:

• \- Are not an anesthesia provider at The University of Iowa Hospitals and Clinics

Sponsors & Collaborators

• Sundara Reddy: lead
• Microdermis Corporation: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Limitations and Caveats

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).

Results Point of Contact

• Title: Sundara Reddy, MBBS
• Organization: University of Iowa Hospitals and Clinics

sundarareddy-durgempuditripura@uiowa.edu

(319) 356-2108

Study Officials

• Sundar Durgempudi Tripura, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Loreen Herwaldt, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Anesthesia providers will serve as their own controls

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: July 17, 2019
• Study Start: December 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 2, 2021
• Results First Posted: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)