Evaluation of Two Hand Hygiene Products in ICUs

NCT02258412 | Completed Phase 4 Results FDA Drug

• 1 other identifier: EM-05-013218
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the immediate antimicrobial efficacy and persistence of two hand hygiene products on ICU Health Care Worker's skin flora by measuring bacterial organisms on hands using the hand print method. It is hypothesized that the product containing Chlorhexidine gluconate will provide more persistence than the alcohol product, resulting in less bacterial growth on the hand print plates. In addition, environmental monitoring for cleanliness will be captured from high touch surfaces in ICU patient rooms and common areas using Rodac plates and adenosine triphosphate tests.

Conditions

Hand Hygiene Effectiveness

Keywords

antimicrobial; efficacy; hand; hygiene; bacteria

Outcome Measures

Primary Outcomes (1)

• Bacterial Colony Forming Units Present on Hand Prints After Time Spent in Common Areas

  Hand print plates will be collected from HCWs immediately after use of hand hygiene product and after time spent in common areas. Each HCW will use both products at least 3 days apart. Hand print plates from each product for each HCW will be compared.

  On each of 2 days, Hand print plates collected from one hand immediately after product use (T0) and from other hand after time spent in MICU common areas

Study Arms (2)

Alcohol hand sanitizer foam

ACTIVE COMPARATOR

Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day.

Drug: Alcohol hand sanitizer foam

hand antiseptic with CHG and alcohol

ACTIVE COMPARATOR

Hand antiseptic is applied by dispensing 1 pump into hands, spreading over the hands up to the wrist, and rubbing until dry. Hand antiseptic will be used twice approximately 15-30 minutes apart on one day.

Drug: hand antiseptic with CHG and alcohol

Interventions

hand antiseptic with CHG and alcohol DRUG

HCWs will be randomized to use one product on one day and the other product on another day at least 3 days apart. Each product will be applied using 1 pump from its dispenser and rubbed over the hands until dry. Gloves will be worn while the HCW is in the patient room. Upon exit from the room, HCW will washoout with that same product. One imprint will be made of the non-dominant hand onto media containing neutralizers. That hand will be gloved with a white cotton glove. The HCW will work in the common areas with timing recorded. Upon leaving the common area, the dominant ungloved hand will be imprinted onto a fresh media plate containing neutralizers.

Also known as: Avagard CHG Hand Antiseptic with Moisturizers, Purell Advanced Instant Hand Sanitizer Foam

hand antiseptic with CHG and alcohol

Alcohol hand sanitizer foam DRUG

Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day

Also known as: Purell Instant Sanitizer Foam

Alcohol hand sanitizer foam

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HCW willing to participate in the study
• HCW willing to use non-Triclosan soap when soap is necessary throughout the study
• HCW who will don gloves prior to ICU patient room entry

You may not qualify if:

• Use of any CHG -containing products ( liquid hand soap, Sage wipes) on the ICU 72 hours prior to study initiation and throughout study
• HCW with patient bandage or other dressing on palm(s)
• Known sensitivity or allergy to CHG or alcohols in hand hygiene products
• Known sensitivity or allergy to the following components: Lecithin, Polysorbate 80,Trypticase Soy Agar, sodium bisulfate, sodium thioglycollate, sodium thiosulfate
• History of skin allergies

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Deshpande A, Fox J, Wong KK, Cadnum JL, Sankar T, Jencson A, Schramm S, Fraser TG, Donskey CJ, Gordon S. Comparative Antimicrobial Efficacy of Two Hand Sanitizers in Intensive Care Units Common Areas: A Randomized, Controlled Trial. Infect Control Hosp Epidemiol. 2018 Mar;39(3):267-271. doi: 10.1017/ice.2017.293. Epub 2018 Jan 31.

  PMID: 29382400 DERIVED

MeSH Terms

Interventions

Hand Sanitizers; Chromogranins; Ethanol

Intervention Hierarchy (Ancestors)

Anti-Infective Agents, Local; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Disinfectants; Specialty Uses of Chemicals; Nerve Tissue Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Alcohols; Organic Chemicals

Results Point of Contact

• Title: Clinical Research Specialist
• Organization: 3M Health Care Business

mdavid@mmm.com

651-736-1578

Study Officials

• Abhishek Deshpande, MD, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: October 7, 2014
• Study Start: October 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2015
• Last Updated: October 23, 2024
• Results First Posted: May 16, 2017

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)