Improving the Supertowel: An Alternative Hand Cleaning Product for Emergencies

NCT04312334 | Completed DMC

• 1 other identifier: LSHTM ethics ref: 18006
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Escherichia Coli Change

Keywords

Escherichia Coli change; Hand-washing; Emergency settings; Hand-cleaning; Hygiene

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Study Arms (11)

Treatment 1

EXPERIMENTAL

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.

Other: Treatment

Treatment 2

EXPERIMENTAL

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.

Other: Treatment

Treatment 3

EXPERIMENTAL

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.

Other: Treatment

Treatment 4

EXPERIMENTAL

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.

Other: Treatment

Treatment 5

EXPERIMENTAL

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.

Other: Treatment

Treatment 6

EXPERIMENTAL

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

Other: Treatment

Control 1

OTHER

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.

Other: Control

Control 2

OTHER

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

Other: Control

Control 3

OTHER

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.

Other: Control

Control 4

OTHER

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.

Other: Treatment

Control 5

OTHER

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.

Other: Control

Interventions

Control OTHER

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.

Also known as: Hand-cleaning with Supertowel or hand-washing with soap

Control 1; Control 2; Control 3; Control 5

Treatment OTHER

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.

Also known as: Treatment with SupeTowel

Control 4; Treatment 1; Treatment 2; Treatment 3; Treatment 4; Treatment 5; Treatment 6

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Kelkar Education Trust's Scientific Research Centre, Mumbai (India): collaborator
• Real Relief Health ApS,Essen 26, 6000 Kolding, Denmark: collaborator
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

KETs Scientific Research Centre

Mumbai, 400 081, India

Location

Related Publications (2)

• 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.

  PMID: 30860009 RESULT

• 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.

  PMID: 31059540 RESULT

MeSH Terms

Interventions

Hand Disinfection; Soaps; Therapeutics

Intervention Hierarchy (Ancestors)

Hand Hygiene; Hygiene; Public Health; Environment and Public Health; Detergents; Surface-Active Agents; Specialty Uses of Chemicals; Chemical Actions and Uses; Household Products; Technology, Industry, and Agriculture

Study Officials

• Belen Torondel, Dr

  Dr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be masked to treatment.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 18, 2020
• Study Start: February 25, 2020
• Primary Completion: April 30, 2020
• Study Completion: May 30, 2020
• Last Updated: June 5, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2 years
• 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.

Locations

IN (1)