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Completed

NCT Number: NCT04312334

Improving the Supertowel: An Alternative Hand Cleaning Product for Emergencies

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

KETs Scientific Research Centre

Mumbai, 400 081, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Hand-cleaning with Supertowel or hand-washing with soap

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.

Other names: Treatment with SupeTowel

Primary outcomes

  1. Change of E.coli

    Time frame: 24 hours

    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.

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

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)

Registry information

Acronym: Supertowel

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 18, 2020
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.