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 cleaning of exposed skin and hair surfaces (decontamination) is critical to ensuring the wellbeing of all casualties. During an incident, some casualties may need to undergo a specialised form of decontamination known as non-ambulant clinical decontamination. This process takes place in clinical decontamination units which provide a sheltered area for injured (non-ambulant) casualties to be showered with warm water by ambulance personnel wearing full personal protective equipment known as PRPS (powered respirator protective suit). The current process for clinical decontamination is poorly defined, is difficult to perform when wearing PRPS and can take up to 15 minutes per person. Recent studies have identified a new clinical decontamination process. The new method is shorter (5 minutes) and can be performed by staff wearing PRPS. However, the effectiveness of the new process has not been tested. Therefore, the aim of this study is to assess the effectiveness of the new clinical decontamination response using human volunteers.
Who can participate?
Volunteers aged 18 – 60
What does the study involve?
Each participant is asked to wear a swim suit. Exposed skin/hair surfaces are “dosed” at various sites with a liquid chemical mixture which has a safe history of use in previous studies. The participants are then randomly allocated to either be treated using the new clinical decontamination protocol or to receive no treatment. The amount of chemical remaining on the hair and skin surfaces is measured and compared between the two groups.
What are the possible benefits and risks of participating?
There is no immediate benefit to the participants. 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-0217A
Study information
Scientific title
Evaluation of a non-ambulant clinical decontamination procedure
Acronym
Study hypothesis
Clinical decontamination has no significant effect on reducing dermal exposure to a liquid chemical in non-ambulant, contaminated casualties.
Ethics approval
Independent Ethical Review Committee, 03/03/2017, ref: ITX-IERC-0217A
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 the contact details to request a patient information sheet
Condition
Exposure to toxic materials
Intervention
Volunteers were randomly assigned to each treatment group 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/). One group will be subject to the revised clinical decontamination protocol following exposure to a curcumin/methyl salicylate mixture (CMX). The second group will be exposed to CMX but will receive no other intervention.
Each participant will be asked to wear a swim suit. Exposed skin/hair surfaces will be “dosed” at various sites with a liquid chemical mixture which has a safe history of use in previous studies. The participants will then be treated using the revised clinical decontamination protocol or receive no other intervention according to which group they are allocated to. The amounts of chemical remaining on the hair and skin surfaces will subsequently be quantified and compared to a group of participants who have not been treated.
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
Semi-quantitative determination of the area of contamination 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
24/02/2017
Overall trial end date
24/03/2017
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. Currently taking blood-thinning agents (anti-coagulant or anti-platelet)
3. Renal impairment
4. Inflammatory disorder affecting the skin
5. Partially healed/open wounds
6. Respiratory condition (other than controlled asthma)
7. Pregnant or breastfeeding
8. Any other relevant condition at the discretion of an independent physician
Recruitment start date
03/03/2017
Recruitment end date
07/03/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Intertox Ltd
5C Brydges Court
Ludgershall
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. Initially, the results will be reported to the sponsor as a confidential (internal) technical report. On request from the sponsor, wider dissemination of the results may be achieved through abstract/poster presentations at appropriate scientific conferences or through publication in an appropriate peer-reviewed journal.
IPD sharing statement
The datasets generated during and/or analysed during the current study is not expected to be made available due to issues of data confidentiality.
Intention to publish date
24/06/2018
Participant level data
Not expected to be available
Basic results (scientific)
Publication list