Association of Dutch Burn Centres
Beverwijk, North Holland, 1942 LE, Netherlands
NCT Number: NCT03007264
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Beverwijk, North Holland, 1942 LE, Netherlands
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CAP will be applied on one volar arm of volunteers for a total of 2 minutes.
Time frame: before to 30 minutes after treatment
by using a visual analogue thermometer (VAT)
Time frame: directly to 30 minutes after treatment
blister formation, itching
Time frame: before to 30 minutes after treatment
thermographic analysis
Time frame: before to 30 minutes after treatment
erythema, redness of the skin, by using a Dermaspectrometer
Time frame: before to 30 minutes after treatment
barrier function of the skin by using TEWAmeter
Time frame: directly to 5 minutes after treatment
quantified with scrub wash method
Association of Dutch Burn Centres
Other
Safety Assessment of Cold Gas Plasma on Intact Skin
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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