Escherichia Coli ChangeSupertowelNCT04312334
Improving the Supertowel: An Alternative Hand Cleaning Product for Emergencies
A study testing Treatment in people with Escherichia Coli Change, run by London School of Hygiene and Tropical Medicine at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Escherichia Coli Change
- What is being tested?
- Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndia
- Study dates
- 25 Feb 2020to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
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. 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.
Read the 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.
- Conditions
- Escherichia Coli Change
- Being tested
- Control, Treatment
- Keywords
- Escherichia Coli change, Hand-washing, Emergency settings, Hand-cleaning, Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Also called Hand-cleaning with Supertowel or hand-washing with soap
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.
TreatmentOther
Also called Treatment with SupeTowel
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Treatment |
| Treatment 6 | Experimental | Treatment 6: Hand cleaning with the Supertowel which is fully dry for 60 seconds. Receives: 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. Receives: 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 Receives: 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. Receives: 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start25 Feb 2020
- Primary completion30 Apr 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Escherichia Coli ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or 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)
- Responsible party
- Sponsor
- Investigators
- Belen Torondel, Dr, Principal investigator, Dr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312334
- Sponsor's protocol ID
- LSHTM ethics ref: 18006
- Acronym
- Supertowel
- Status last verified
- Mar 2020
- First submitted
- 12 Mar 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once we have the results analyzed and published we are happy to share the results with other interested researchers.
Publications
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.
PubMed 30860009White 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.
PubMed 31059540
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Supertowel: An Alternative Hand Cleaning Product for Emergencies
- ClinicalTrials.gov ID
- NCT04312334
- Acronym / sponsor ID
- Supertowel / LSHTM ethics ref: 18006
- Conditions
- Escherichia Coli Change
- Keywords
- Escherichia Coli change, Hand-washing, Emergency settings, Hand-cleaning, Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or 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)
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 11
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Other: TreatmentTreatment 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 | Experimental | Other: TreatmentTreatment 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 | Experimental | Other: TreatmentTreatment 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 | Experimental | Other: TreatmentTreatment 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 | Experimental | Other: TreatmentTreatment 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 | Experimental | Other: TreatmentTreatment 6: Hand cleaning with the Supertowel which is fully dry for 60 seconds. |
| Control 1 | Other | Other: ControlControl 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 | Other | Other: ControlControl 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 | Other | Other: ControlControl 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 | Other | Other: TreatmentControl 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. |
| Control 5 | Other | Other: ControlHand 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlAlso: Hand-cleaning with Supertowel or hand-washing with soapSoap: 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 | Control 1, Control 2, Control 3, Control 5 |
| TreatmentAlso: Treatment with SupeTowelThe 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 | Control 4, Treatment 1, Treatment 2, Treatment 3, Treatment 4, Treatment 5, Treatment 6 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Results publication: PubMed 30860009Torondel 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 publication: PubMed 31059540White 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.
- Individual participant dataSharing planned: Yes. Once we have the results analyzed and published we are happy to share the results with other interested researchers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Belen Torondel, Dr principal investigator
Dr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment in people with Escherichia Coli Change, run by London School of Hygiene and Tropical Medicine at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of E.coli (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04312334, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.