Intact Skin Clinical Trial
Official title:
Safety Assessment of Cold Gas Plasma on Intact Skin
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04192123 -
Open-Label Test of the HM242 Medical Devices to Evaluate Safety and Local Tolerability
|
N/A |