A Phase 1 interventional study of Cold Atmospheric Plasma in Intact Skin and Contaminant Given to Patient, sponsored by Association of Dutch Burn Centres. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-20.
Sponsored by Association of Dutch Burn Centres · Phase 1, Interventional, and Treatment
In this study the application of cold atmospheric plasma (CAP) will be tested on intact skin of volunteers. To test safety, several skin parameters will be monitored, the antimicrobial effect will be investigated as well. The investigators expect this treatment to have a good antimicrobial effect with acceptable, transient skin sensations.
Control of infection and bacterial colonisation constitutes a continuing challenge in patients with burns. Prevention of microbial contamination and infection is vital for burn wound care as bacterial presence can result in excessive inflammatory reactions, delayed re-epithelialisation, impaired matrix remodelling and bacteraemia. A novel method to decrease the likelihood of infection and to help cure wounds is cold atmospheric plasma (CAP). CAP has been shown in vitro to kill a wide range of pathogenic bacteria.
This safety study aims to demonstrate the safety, efficacy and efficiency of CAP for burn wound treatment. Intact skin of volunteers will be CAP treated. Local skin reaction (blister formation, pain, itching), erythema, local skin temperature, trans epidermal water loss (TEWL) and reduction of the bacterial load wil be monitored.
Association of Dutch Burn Centres is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
volar arm will be treated with cold atmospheric plasma.
Device: Cold Atmospheric Plasma
volar arm with bacteria will be treated with cold atmospheric plasma.
Device: Cold Atmospheric Plasma
volar arm with bacteria will not be treated with cold atmospheric plasma. Sham comparator for measurements of skin parameters TEWL, temperature and bacterial load.
CAP will be applied on one volar arm of volunteers for a total of 2 minutes.
pain
by using a visual analogue thermometer (VAT)
Time frame: before to 30 minutes after treatment
local skin reaction
blister formation, itching
Time frame: directly to 30 minutes after treatment
local skin temperature
thermographic analysis
Time frame: before to 30 minutes after treatment
colour/pigmentation
erythema, redness of the skin, by using a Dermaspectrometer
Time frame: before to 30 minutes after treatment
trans epidermal water loss
barrier function of the skin by using TEWAmeter
Time frame: before to 30 minutes after treatment
reduction of the bacterial load
quantified with scrub wash method
Time frame: directly to 5 minutes after treatment
Plan to share: No
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Association of Dutch Burn Centres