Condition category
Skin and Connective Tissue Diseases
Date applied
26/01/2016
Date assigned
27/01/2016
Last edited
27/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Tufts University

Sponsor details

800 Washington Street
Box 817
Boston
02111
United States of America

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

United States Agency for International Development

Alternative name(s)

USAID

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes