Plain English Summary
Background and study aims
Healthcare workers worldwide often complain of irritation and dryness of the skin on hands as a result of the frequent handwashing necessary to keep both themselves and their patients safe, and there is a lack of good evidence to make recommendations about which handwashing methods are best. These concerns are especially pronounced in a setting where there is a high risk of spreading infection, for example, Ebola treatment centers, where any damage to skin could increase the risk of transmission. Healthcare workers and international emergency responders are seeking clearer handwashing guidelines, especially in the wake of the recent Ebola crisis in West Africa. The goal of this study is to compare the impact of different hand washing methods commonly used in healthcare settings on the development of irritant hand dermatitis to provide evidence from a controlled environment on the impact of these handwashing methods on skin health and comfort.
Who can participate?
Healthy volunteers (men and women) between the ages of 18 and 65.
What does the study involve?
Subjects will be randomly assigned to one of six groups. Those in group 1 are asked to wash their hands with soap and water ten times a day for 28 days. Those in group 2 are asked to use an alcohol-based hand sanitizer. Those in group 3 are asked to wash their hands in 0.05% calcium hypochlorite.Those in group 4 are asked to wash their hands in 0.05% sodium dichloroisocyanurate. Those in group 5 are asked to wash their hands in 0.05% sodium hypochlorite made from commercially available stock solution. Those in group 6 are asked to wash their hands in 0.05% sodium hypochlorite made using an electrochlorinator. During this time participants attend the Tufts University Medford campus to be monitored daily for discomfort or hand irritation.
What are the possible benefits and risks of participating?
Participants are not expected to experience a direct benefit from the study. The study carries with it a mild risk of development of dermatitis, no greater than the risk of frequent (but within normal) handwashing in daily life or work. Subjects may also find the time required to pick up new handwashing materials each day poses a burden.
Where is the study run from?
Tufts University, Department of Civil and Environmental Engineering (USA)
When is the study starting and how long is it expected to run for?
June 2015 to November 2015
Who is funding the study?
United States Agency for International Development
Who is the main contact?
Professor Daniele Lantagne
daniele.lantagne@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Prof Daniele Lantagne
ORCID ID
Contact details
200 College Avenue
Anderson Hall
Tufts University
Medford
02155
United States of America
(617) 627 3211
daniele.lantagne@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
AID-OFDA-A-15-00026
Study information
Scientific title
Comparison of soap, hand sanitizer, and 0.05% NaDCC, HTH, and NaOCl chlorine solutions in the development of dermatitis among healthy volunteers during frequent handwashing
Acronym
Study hypothesis
We hypothesize that the development of dermatitis on the hands among subjects will vary depending on the substance used for handwashing.
Ethics approval
Institutional Review Board at Tufts Medical Center and Tufts University Health Sciences Campus, 08/09/2015, ref: #11818
Study design
Single-centre interventional trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Irritant contact dermatitis is a condition of skin inflammation and skin barrier disruption that can cause transepidermal water loss, itching, redness, swelling, and an increase in disease transmission risk when irritating substances cause dehydration of the stratum corneum.
Intervention
Subjects are randomly allocated to one of six arms. They are asked to wash their hands ten times per day with the handwashing method assigned to them. The handwashing methods are:
1. washing with soap and water
2. alcohol-based hand sanitizer
3. 0.05% calcium hypochlorite
4. 0.05% sodium dichloroisocyanurate
5. 0.05% sodium hypochlorite made from commercially available stock solution
6. 0.05% sodium hypochlorite made using an electrochlorinator
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
1. Hand Eczema Index Score (HECSI). The HECSI score is a measurement of skin irritation on hands composed of individual scores detailing the severity of nine different signs of irritation (itchiness, pain, redness, flaking, cracks in the skin, skin thickening, swelling, bumps, and blisters) on each part of the hands assigned by a trained researcher. A board-certified dermatologist will examine each subject to determine diagnosis of clinical dermatitis. HECSI score is measured at baseline and on each day of the 28 days of handwashing.
2. Clinical diagnosis of dermatitis. Dermatitis diagnosis takes place at endline, at the end of day 28 of handwashing.
Secondary outcome measures
1. Allergy patch testing. Patch testing is conducted to determine whether subjects have an allergy to any substance that might be a confounding factor if the subject develops irritation or dermatitis and is done by placing a patch with small discs containing each substance used for handwashing on the upper back from 48hrs. Researchers then view the area for signs of allergy at 48hr, 96hrs, and 7 days.
2. Self-rated hand score. For the self-rated hand score subjects used a scale from 0-10 to self-rate the level of discomfort that they were currently experiencing on their hands along with nine different symptoms, including itchiness, pain, redness, flaking, cracks in the skin, skin thickening, swelling, bumps, and blisters.
Overall trial start date
01/06/2015
Overall trial end date
18/11/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Potential participants must be:
1. healthy volunteers
2. either gender
3. aged between 18-65
4. English-speaking
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
108
Participant exclusion criteria
Potential participants must not:
1. have a history of dermatitis
2. be pregnant or trying to become pregnant
3. patch test positive for any study substance
4. have baseline skin abnormalities or open sores/cuts
5. work in a profession where hands are frequently wet or exposed to irritants
6. have mental health issues that may be triggered by a study related to hand hygiene
Recruitment start date
11/09/2015
Recruitment end date
30/09/2015
Locations
Countries of recruitment
United States of America
Trial participating centre
Tufts University, Department of Civil and Environmental Engineering
113 Anderson Hall
200 College Avenue
Medford, MA
02155
United States of America
Funders
Funder type
Government
Funder name
United States Agency for International Development
Alternative name(s)
U.S. Agency for International Development, USAID
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
31/12/2016
Participant level data
Available on request
Basic results (scientific)
Publication list
2016 results in https://www.ncbi.nlm.nih.gov/pubmed/28030544