Seeking clearer recommendations for hand hygiene in communities facing Ebola: a randomized trial investigating the impact of six handwashing methods on skin irritation and dermatitis
| ISRCTN | ISRCTN89815514 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89815514 |
| Protocol serial number | AID-OFDA-A-15-00026 |
| Sponsor | Tufts University |
| Funder | United States Agency for International Development |
- Submission date
- 26/01/2016
- Registration date
- 27/01/2016
- Last edited
- 16/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
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
Contact information
Scientific
200 College Avenue
Anderson Hall, Tufts University
Medford
02155
United States of America
| Phone | (617) 627 3211 |
|---|---|
| daniele.lantagne@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre interventional trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | We hypothesize that the development of dermatitis on the hands among subjects will vary depending on the substance used for handwashing. |
| Ethics approval(s) | Institutional Review Board at Tufts Medical Center and Tufts University Health Sciences Campus, 08/09/2015, ref: #11818 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 18/11/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 108 |
| Key inclusion criteria | Potential participants must be: 1. healthy volunteers 2. either gender 3. aged between 18-65 4. English-speaking |
| Key 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 |
| Date of first enrolment | 11/09/2015 |
| Date of final enrolment | 30/09/2015 |
Locations
Countries of recruitment
- United States of America
Study participating centre
200 College Avenue
Medford, MA
02155
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/12/2016 | Yes | No | |
| Dataset | Data Dictionary. (XLSX) | 16/02/2023 | No | No | |
| Dataset | Handwashing Data. (XLSX) | 16/02/2023 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/02/2023: Links to datasets added.
25/09/2017: Internal review
29/12/2016: Publication reference added.
