search
Back to results

Improving the Supertowel: An Alternative Hand Cleaning Product for Emergencies (Supertowel)

Primary Purpose

Escherichia Coli Change

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Control
Treatment
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Escherichia Coli Change focused on measuring Escherichia Coli change, Hand-washing, Emergency settings, Hand-cleaning, Hygiene

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

To be eligible volunteers must:

  • Be male and older than 18 years old.
  • Be physically examined to ensure they are healthy and with healthy skin (without skin disorders like eczema, paronychia, scabies, abrasions, lacerations or skin allergy).
  • Have short fingernails with no artificial nails.
  • Have no history of drug allergy.
  • Nothave taken any systemic antibiotic in the two weeks prior to the study, which could otherwise impair the efficacy of the product being tested.
  • Remove all forms of jewellery from their hands prior to hand washing, since it has the potential of retain some bacteria, which could affect the recovery pre and post values of the test.

Exclusion Criteria:

  • Unhealthy volunteers and volunteers with unhealthy skin, history of drug allergy, taken systemic antibiotics in the previous two weeks of the study will be excluded from the study.

Sites / Locations

  • KETs Scientific Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Other

Other

Other

Other

Other

Arm Label

Treatment 1

Treatment 2

Treatment 3

Treatment 4

Treatment 5

Treatment 6

Control 1

Control 2

Control 3

Control 4

Control 5

Arm Description

Treatment 1: Hand cleaning with the Supertowel for 15 seconds. The Supertowel will be soaked in water by submersing it completely in a bucket filled with tap water. The amount of water absorbed by the ST will be recorded by means of weighing the towel before and after soaking. The volunteers will use the soaked Supertowel for 15 seconds to clean their pre-contaminated hands.

Treatment 2: Hand cleaning with a Supertowel that is damp for 60 seconds The Supertowel will be soaked in water by submersing it completely in a bucket filled with tap water. The water on the Supertowel will then be squeezed out so that it is not dripping. The Supertowel will be weighed before soaking and after squeezing. Volunteers will clean their pre-contaminated hands with the damp Supertowel for 60 seconds.

Treatment 3: Hand cleaning for 60 seconds with a Supertowel that has been soaked in contaminated water. A Supertowel will be soaked in water which has artificially contaminated with non-pathogenic E.coli. The water will be designed to mimic highly contaminated grey water so it will be contaminated at 2,000 cfu/100 ml which is double the acceptable level of contamination for handwashing. Volunteers will clean their pre-contaminated hands with the contaminated Supertowel for 60 seconds.

Treatment 4: Hand cleaning for 60 seconds with a Supertowel that is visibly dirty and oily. The Supertowel will be made visibly dirty and oily for example, by immersing it in a mix of 10 grams of sterile soil (previously autoclaved), 1 ml of clean cooking oil and 100 ml of water .The Supertowel will be rubbed against itself to ensure the soil and oil are spread out across the surface of the Supertowel. Volunteers will clean their pre-contaminated hands with the dirty Supertowel for 60 seconds.

Treatment 5: Hand cleaning for 30 seconds with a Supertowel that is visibly dirty and oily and it is soaked in whater which has artificially contaminated with non-pathogenic E.coli. The Supertowel will be made visibly dirty and oily for example, by immersing it in a mix of 10 grams of sterile soil (previously autoclaved), 1 ml of clean cooking oil and 100 ml of water (which will be contaminated with E.coli).The Supertowel will be rubbed against itself to ensure the soil and oil are spread out across the surface of the Supertowel. Volunteers will clean their pre-contaminated hands with the dirty Supertowel for 30 seconds.

Treatment 6: Hand cleaning with the Supertowel which is fully dry for 60 seconds.

Control 1: Hand washing with bar soap and water for 15 seconds. The control group will wash their pre-contaminated hands with normal bar soap and water for 15 seconds. Hands from volunteers washed with soap will be allowed to dry for 3 minutes.

Control 2: Handwashing with bar soap and water for 60 seconds The control group will wash their pre-contaminated hands with normal bar soap and water for 60 seconds by following the "WHO guidelines for handwashing when hands are visibly soiled" (a diagram of the steps was given to them, appendix). After handwashing, hands will be allowed to dry for 3 minutes

Control 3: Handwashing with bar soap and contaminated water for 60 seconds. Water which is contaminated with non-pathogenic E.coli. at 2,000 cfu/100ml will be stored in a bucket which has a tap at the base. The control group volunteers will wash their hands with the contaminated water and bar soap for 60 seconds. They will follow the "WHO guidelines for handwashing when hands are visibly soiled" (a diagram of the steps will be given to them). After handwashing, hands will be allowed to dry for 3 minutes.

Control 4: Hand cleaning for 60 seconds with a clean Supertowel. The Supertowel will be soaked in water by submersing it completely in a bucket filled with tap water. The amount of water absorbed by the ST will be recordedby means of weighing the Supertowel before and after soaking. The control group will clean their pre-contaminated hands of with thesoaked Supertowel for 60 seconds.

Hand washing with bar soap and water for 30 seconds. The control group will wash their pre-contaminated hands with normal bar soap and water for 30 seconds. Hands from volunteers washed with soap will be allowed to dry for 3 minutes.

Outcomes

Primary Outcome Measures

Change of E.coli
Reduction of bacteria (E.coli (ATCC 11229)) in pre-contaminated hands of volunteers after using the different test conditions. This procedure is based on the "post-contamination" treatment of hands and involves the placement of the test organism (E.coli (ATCC 11229)) on the hands of test subjects, followed by exposure of the test product. For both the Supertowel product or soap treatments, log10 counts from left and right hands of each subject were averaged separately, for both pre- and post-values. The arithmetic means of all individuals log10 changes values will be calculated.

Secondary Outcome Measures

Full Information

First Posted
March 12, 2020
Last Updated
June 4, 2020
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Kelkar Education Trust's Scientific Research Centre, Mumbai (India), Real Relief Health ApS,Essen 26, 6000 Kolding, Denmark, United States Agency for International Development (USAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT04312334
Brief Title
Improving the Supertowel: An Alternative Hand Cleaning Product for Emergencies
Acronym
Supertowel
Official Title
Improving the Supertowel: An Alternative Hand Cleaning Product for Emergencies
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 25, 2020 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
May 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Kelkar Education Trust's Scientific Research Centre, Mumbai (India), Real Relief Health ApS,Essen 26, 6000 Kolding, Denmark, United States Agency for International Development (USAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The Supertowel is a microfiber towel treated with a permanent anti-microbial bonding and has been designed as a soap alternative in emergency situations.The treated fabric must be dipped in water and then rubbed against the hands so that pathogens will be transferred to the fabric where they will be killed. Over the last two years the investigators have been able to prove, under controlled laboratory conditions, that hand cleaning with the Supertowel is more efficacious than handwashing soap and water. Another field study conducted by the investigators in a refugee camp in Northern Ethiopia indicated that the Supertowel is an acceptable and desirable product among crisis-affected populations and is likely to result in more frequent handwashing in these difficult circumstances. The aim of this study is to develop greater evidence on whether the Supertowel remains is as efficacious when used under conditions which mimic "real-world hand cleaning conditions". This will be tested through a set of controlled laboratory experiments with healthy volunteers in India.
Detailed Description
The Supertowel is a microfiber towel treated with a permanent anti-microbial bonding and has been designed as a soap alternative in emergency situations. The treated fabric must be dipped in water and then rubbed against the hands so that pathogens will be transferred to the fabric where they will be killed. Several laboratory test have demonstrated the bactericidal effect of the fabric against different bacteria. The Supertowel will kill microbes efficiently and within seconds once the microbe is on the towel. The Supertowel provides an alternative to large-scale soap distribution. It could be beneficial to emergency responders as it will be easier (smaller and lighter) to distribute and last longer than soap, negating the need for frequent distributions. The Supertowel will reduce water wastage associated with hand washing and reduce drainage problems that are often seen around hand washing facilities. The Supertowel will also be beneficial to those effected by emergencies as it can easily be carried by users all the time, making hand cleaning more convenient. Over the last two years the investigators have been able to prove, under controlled laboratory conditions, that hand cleaning with the Supertowel is more efficacious than handwashing soap and water. Another field study conducted by the investigators in a refugee camp in Northern Ethiopia indicated that the Supertowel is an acceptable and desirable product among crisis-affected populations and is likely to result in more frequent handwashing in these difficult circumstances. The aim of this study is to develop greater evidence on whether the Supertowel remains is as efficacious when used under conditions which mimic "real-world hand cleaning conditions". This will be tested through a set of controlled laboratory experiments with healthy volunteers in India. We will be testing the efficacy of the Supertowel as a hand-cleaning product using simulations of 'real-world' hand cleaning conditions. To test the efficacy of the Supertowel under the different conditions, we will use a crossover controlled study based and adapted on the protocol of the European Committee for Standardization (EN 1499) which is designed to evaluate the ability of hand-wash agents to eliminate transient pathogens from volunteers' hands without regard to resident microorganisms. This procedure is based on the "post-contamination treatment" of hands and involves the placement of the test organism (E. coli [ATCC 11229]) on the hands of test subjects, followed by exposure of the test product. The study will be organized in two rounds of tests. 32 healthy volunteers will be selected for the study. 16 volunteers will be invited for the first round and 16 more for the second round. Each volunteer will receive treatment with all the different procedures the same day of visit to the laboratory. This is a single centre study conducted in KET's Scientific Research Centre, Mumbai (India). The recruitment and performance of tests will be done at KET's Scientific Research Centre, Mumbai (India) Laboratory of India.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Escherichia Coli Change
Keywords
Escherichia Coli change, Hand-washing, Emergency settings, Hand-cleaning, Hygiene

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
To test the efficacy of the Supertowel under the different conditions, we will use a crossover controlled study based and adapted on the protocol of the European Committee for Standardization (EN 1499) which is designed to evaluate the ability of hand-wash agents to eliminate transient pathogens from volunteers' hands without regard to resident microorganisms. This procedure is based on the "post-contamination treatment" of hands and involves the placement of the test organism (E. coli [ATCC 11229]) on the hands of test subjects, followed by exposure of the test product.The study will be organized in two rounds of tests.
Masking
Outcomes Assessor
Masking Description
The outcome assessor will be masked to treatment.
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment 1
Arm Type
Experimental
Arm Description
Treatment 1: Hand cleaning with the Supertowel for 15 seconds. The Supertowel will be soaked in water by submersing it completely in a bucket filled with tap water. The amount of water absorbed by the ST will be recorded by means of weighing the towel before and after soaking. The volunteers will use the soaked Supertowel for 15 seconds to clean their pre-contaminated hands.
Arm Title
Treatment 2
Arm Type
Experimental
Arm Description
Treatment 2: Hand cleaning with a Supertowel that is damp for 60 seconds The Supertowel will be soaked in water by submersing it completely in a bucket filled with tap water. The water on the Supertowel will then be squeezed out so that it is not dripping. The Supertowel will be weighed before soaking and after squeezing. Volunteers will clean their pre-contaminated hands with the damp Supertowel for 60 seconds.
Arm Title
Treatment 3
Arm Type
Experimental
Arm Description
Treatment 3: Hand cleaning for 60 seconds with a Supertowel that has been soaked in contaminated water. A Supertowel will be soaked in water which has artificially contaminated with non-pathogenic E.coli. The water will be designed to mimic highly contaminated grey water so it will be contaminated at 2,000 cfu/100 ml which is double the acceptable level of contamination for handwashing. Volunteers will clean their pre-contaminated hands with the contaminated Supertowel for 60 seconds.
Arm Title
Treatment 4
Arm Type
Experimental
Arm Description
Treatment 4: Hand cleaning for 60 seconds with a Supertowel that is visibly dirty and oily. The Supertowel will be made visibly dirty and oily for example, by immersing it in a mix of 10 grams of sterile soil (previously autoclaved), 1 ml of clean cooking oil and 100 ml of water .The Supertowel will be rubbed against itself to ensure the soil and oil are spread out across the surface of the Supertowel. Volunteers will clean their pre-contaminated hands with the dirty Supertowel for 60 seconds.
Arm Title
Treatment 5
Arm Type
Experimental
Arm Description
Treatment 5: Hand cleaning for 30 seconds with a Supertowel that is visibly dirty and oily and it is soaked in whater which has artificially contaminated with non-pathogenic E.coli. The Supertowel will be made visibly dirty and oily for example, by immersing it in a mix of 10 grams of sterile soil (previously autoclaved), 1 ml of clean cooking oil and 100 ml of water (which will be contaminated with E.coli).The Supertowel will be rubbed against itself to ensure the soil and oil are spread out across the surface of the Supertowel. Volunteers will clean their pre-contaminated hands with the dirty Supertowel for 30 seconds.
Arm Title
Treatment 6
Arm Type
Experimental
Arm Description
Treatment 6: Hand cleaning with the Supertowel which is fully dry for 60 seconds.
Arm Title
Control 1
Arm Type
Other
Arm Description
Control 1: Hand washing with bar soap and water for 15 seconds. The control group will wash their pre-contaminated hands with normal bar soap and water for 15 seconds. Hands from volunteers washed with soap will be allowed to dry for 3 minutes.
Arm Title
Control 2
Arm Type
Other
Arm Description
Control 2: Handwashing with bar soap and water for 60 seconds The control group will wash their pre-contaminated hands with normal bar soap and water for 60 seconds by following the "WHO guidelines for handwashing when hands are visibly soiled" (a diagram of the steps was given to them, appendix). After handwashing, hands will be allowed to dry for 3 minutes
Arm Title
Control 3
Arm Type
Other
Arm Description
Control 3: Handwashing with bar soap and contaminated water for 60 seconds. Water which is contaminated with non-pathogenic E.coli. at 2,000 cfu/100ml will be stored in a bucket which has a tap at the base. The control group volunteers will wash their hands with the contaminated water and bar soap for 60 seconds. They will follow the "WHO guidelines for handwashing when hands are visibly soiled" (a diagram of the steps will be given to them). After handwashing, hands will be allowed to dry for 3 minutes.
Arm Title
Control 4
Arm Type
Other
Arm Description
Control 4: Hand cleaning for 60 seconds with a clean Supertowel. The Supertowel will be soaked in water by submersing it completely in a bucket filled with tap water. The amount of water absorbed by the ST will be recordedby means of weighing the Supertowel before and after soaking. The control group will clean their pre-contaminated hands of with thesoaked Supertowel for 60 seconds.
Arm Title
Control 5
Arm Type
Other
Arm Description
Hand washing with bar soap and water for 30 seconds. The control group will wash their pre-contaminated hands with normal bar soap and water for 30 seconds. Hands from volunteers washed with soap will be allowed to dry for 3 minutes.
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Hand-cleaning with Supertowel or hand-washing with soap
Intervention Description
Soap: Non-antimicrobial bar soap will be used as a reference product for four of the the experiments. Hand-cleaning with SuperTowel will be the reference produce for two of the experiments.
Intervention Type
Other
Intervention Name(s)
Treatment
Other Intervention Name(s)
Treatment with SupeTowel
Intervention Description
The Supertowel is a durable fabric with a permanent anti-microbial treatment. The treated fabric must be dipped in water and then rubbed against the hands so that pathogens will be transferred to the fabric where they will be killed.
Primary Outcome Measure Information:
Title
Change of E.coli
Description
Reduction of bacteria (E.coli (ATCC 11229)) in pre-contaminated hands of volunteers after using the different test conditions. This procedure is based on the "post-contamination" treatment of hands and involves the placement of the test organism (E.coli (ATCC 11229)) on the hands of test subjects, followed by exposure of the test product. For both the Supertowel product or soap treatments, log10 counts from left and right hands of each subject were averaged separately, for both pre- and post-values. The arithmetic means of all individuals log10 changes values will be calculated.
Time Frame
24 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: To be eligible volunteers must: Be male and older than 18 years old. Be physically examined to ensure they are healthy and with healthy skin (without skin disorders like eczema, paronychia, scabies, abrasions, lacerations or skin allergy). Have short fingernails with no artificial nails. Have no history of drug allergy. Nothave taken any systemic antibiotic in the two weeks prior to the study, which could otherwise impair the efficacy of the product being tested. Remove all forms of jewellery from their hands prior to hand washing, since it has the potential of retain some bacteria, which could affect the recovery pre and post values of the test. Exclusion Criteria: Unhealthy volunteers and volunteers with unhealthy skin, history of drug allergy, taken systemic antibiotics in the previous two weeks of the study will be excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Belen Torondel, Dr
Organizational Affiliation
Dr
Official's Role
Principal Investigator
Facility Information:
Facility Name
KETs Scientific Research Centre
City
Mumbai
ZIP/Postal Code
400 081
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Once we have the results analyzed and published we are happy to share the results with other interested researchers.
IPD Sharing Time Frame
2 years
IPD Sharing Access Criteria
The PI and Co-Is will decide whether to grant release of the data based on these requests. Our intended policy will be to make data available to researchers, within 2 years of completion of the study. This is to make maximum use of data collected using public funding while protecting the intellectual property rights of the study team.
Citations:
PubMed Identifier
30860009
Citation
Torondel B, Khan R, Holm Larsen T, White S. Efficacy of the SuperTowel(R): An Alternative Hand-washing Product for Humanitarian Emergencies. Am J Trop Med Hyg. 2019 May;100(5):1278-1284. doi: 10.4269/ajtmh.18-0860.
Results Reference
result
PubMed Identifier
31059540
Citation
White S, Petz JF, Desta K, Holm Larsen T. Could the Supertowel be used as an alternative hand cleaning product for emergencies? An acceptability and feasibility study in a refugee camp in Ethiopia. PLoS One. 2019 May 6;14(5):e0216237. doi: 10.1371/journal.pone.0216237. eCollection 2019.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-015-0532-z
Available IPD/Information Comments
Our data will be suitable for sharing in anonymised form.Potential users will learn about the data on the websites of the collaborating institutes, and links to the relevant data repositories will be available on those websites.The link will contain information on how to apply to use the data. We aim to offer controlled access to study data. Potential users of the data will be invited to register and provide information on their aims and proposed analyses of the data. The PI and Co-Is will decide whether to grant release of the data based on these requests. Our intended policy will be to make data available to researchers, within 2 years of completion of the study. This is to make maximum use of data collected using public funding while protecting the intellectual property rights of the study team.Restrictions or delays to sharing, with planned actions to limit such restrictions We would like to retain exclusive use for 2 years

Learn more about this trial

Improving the Supertowel: An Alternative Hand Cleaning Product for Emergencies

We'll reach out to this number within 24 hrs