Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/08/2017
Date assigned
24/08/2017
Last edited
24/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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?
National Ambulance Resilience Unit (UK)

Who is the main contact?
Tracey Thomas

Trial website

Contact information

Type

Public

Primary contact

Mrs Tracey Thomas

ORCID ID

Contact details

5C Brydges Court
Ludgershall
SP11 9FT
United Kingdom

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 measures

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

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

Sponsor information

Organisation

Intertox Ltd

Sponsor details

5C Brydges Court
Ludgershall
SP11 9FT
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Government

Funder name

National Ambulance Resilience Unit

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

24/02/2019

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes