Plain English Summary
Background and study aims
The accidental or deliberate release of a hazardous substance may result in a large number of contaminated casualties. The rapid removal of clothing (disrobe) and cleaning of exposed skin and hair surfaces (decontamination) is critical to ensuring the wellbeing of all casualties. However, there is currently no formal process for treating casualties who are unable to perform disrobe and decontamination on themselves. Such casualties are categorised by the general term non-ambulant. Therefore, the aim of this study is to develop a new procedure that will allow ambulance staff to perform effective disrobe and decontamination on behalf of non-casualties. Previous studies have demonstrated that for most liquid chemicals, decontamination is best performed using dry, absorbent materials. In an emergency, an Ambulance Crew would need to use any readily available material such as wound dressings, incontinence pads or ‘blue roll’. Blue roll is a type of paper towel which is available on all ambulances and so is an ideal candidate for use as a decontamination product. The aim of this study is to assess the effectiveness of disrobe and decontamination (using blue roll) using human volunteers.
Who can participate?
Volunteers aged 18 – 60
What does the study involve?
Each participant is given a set of over-clothes to wear and a swim suit to wear underneath the clothes to preserve modesty. The clothes and exposed skin/hair surfaces are “dosed” at various sites with a liquid chemical which has a safe history of use in previous studies. Participants are randomly allocated to one of two groups. Participants in one group are disrobed by cutting away their clothing using a standard Ambulance Service method and decontaminated using blue roll. Participants in the other group are not treated. The amount of chemical remaining on their hair and skin is measured and compared between the two groups.
What are the possible benefits and risks of participating?
There is no immediate benefit to volunteers. It is not anticipated that there will be any side effects as a result of participation in this study.
Where is the study run from?
Intertox Ltd (UK)
When is the study starting and how long is it expected to run for?
February 2017 to March 2017
Who is funding the study?
Zeal Solutions Ltd (UK)
Who is the main contact?
Tracey Thomas
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ITX-IERC-0117A
Study information
Scientific title
Development of a non-ambulant dry decontamination procedure: a randomised controlled trial
Acronym
Study hypothesis
The null hypothesis is that disrobe and dry decontamination has no significant effect on reducing dermal exposure to a liquid chemical in non-ambulant, contaminated casualties.
Ethics approval
Independent Ethics Review Committee, 24/02/2017, ref: ITX-IERC-0117A
Study design
Randomised blind control design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Contamination with toxic material
Intervention
All participants will be dosed with a fluorescent chemical contaminant over a total of 16 discrete areas of clothing, hair and skin. They are randomly assigned to two groups using an online treatment allocation generator (Urbaniak, G. C., & Plous, S. (2013). Research Randomizer (Version 4.0) [Computer software]. Retrieved on 22/06/2013, from http://www.randomizer.org/). Individuals in one group will then undergo disrobe and decontamination, with the other group being untreated (control). Eight individuals will be allocated to each treatment group. The purpose of the study will be to quantify the relative effectiveness of disrobe and decontamination in removing the contaminant by comparison with no treatment (controls).
Fluorescent images of each participant will be acquired (i) before exposure (baseline), (ii) following contamination and (iii) on completion the study session. Swabs of the exposed skin and hair surfaces will be taken at the end of the study session. The fluorescent images will be subject to a validated image analysis protocol to determine the distribution of the contaminant. The swabs will be analysed by LC-DAD-MS (liquid chromatography – diode array detector – mass spectrometry) to quantify the amounts of CMX recovered. The primary outcome will be a comparison of the average amounts of chemical contaminant recovered from the skin and hair surfaces of participants between the two treatment groups. Secondary outcomes will be to determine any differences in the surface distribution (fluorescent images) between the two treatment groups.
The chemical contaminant used in the study will be a mixture of a fluorescent compound (curcumin; 10 mg mL-1) dissolved in methyl salicylate (‘CMX’). This will be applied to each volunteer as a 10 µL droplet (hair and skin surfaces) or as a 100 µL droplet (over clothing). The total dose of methyl salicylate will not exceed 720 µL (equivalent to 0.84 g of aspirin).
Intervention type
Other
Phase
Drug names
Primary outcome measure
The effectiveness of the protocol, determined by LC-DAD-MS measurements of the amount of a chemical contaminant (curcumin/methyl salicylate mixture) recovered from the hair and skin of exposed participants in comparison with a control (exposed, untreated) treatment group
Secondary outcome measures
The distribution of the chemical mixture on hair and skin surfaces, observed by fluorescent imaging of exposed participants in comparison with a control (exposed, untreated) treatment group
Overall trial start date
27/02/2017
Overall trial end date
20/03/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Volunteers
2. Male or female
3. Age 18 – 60 (at the start of the study)
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
18
Participant exclusion criteria
1. Allergy to aspirin
2. Renal impairment
3. Inflammatory disorder affecting the skin
4. Partially healed/open wounds
5. Respiratory condition (other than controlled asthma)
6. Pregnant or breastfeeding
7. Any other relevant condition at the discretion of an independent physician
Recruitment start date
27/02/2017
Recruitment end date
06/03/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Intertox Ltd
SP11 9FT
United Kingdom
Funders
Funder type
Industry
Funder name
Zeal Solutions Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The study protocol is available on request. It is intended to publish the result of this study in a relevant, peer-reviewed journal within 24 months of completion of the study.
IPD sharing statement
The datasets generated during and/or analysed during the current study is not expected to be made available due to data confidentiality issues.
Intention to publish date
24/06/2018
Participant level data
Not expected to be available
Basic results (scientific)
Publication list