Clinical trial NCT04312334: Improving the Supertowel: An Alternative Hand Cleaning Product for Emergencies
Official title: Improving the Supertowel: An Alternative Hand Cleaning Product for Emergencies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Escherichia Coli Change
Keywords: Escherichia Coli change
Hand-washing
Emergency settings
Hand-cleaning
Hygiene
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Kelkar Education Trust's Scientific Research Centre, Mumbai (India)
name: Real Relief Health ApS,Essen 26, 6000 Kolding, Denmark
name: United States Agency for International Development (USAID)
First posted: 2020-03-18
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change of E.coli
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: KETs Scientific Research Centre
Study officials:
affiliation: Dr
name: Belen Torondel, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.