Contaminant Given to Patient, Intact Skin
Conditions
Keywords
cold atmospheric plasma, pain, bacteria, skin parameters
Brief summary
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.
Detailed description
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.
Interventions
DEVICECold Atmospheric Plasma
CAP will be applied on one volar arm of volunteers for a total of 2 minutes.
Sponsors
Eindhoven University of Technology
Association of Dutch Burn Centres
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Able and willing to comply with the research protocol * No language barrier
Exclusion criteria
* Atopic dermatitis or other skin disease * Implanted electrical medical devices such cardiac pacemakers * Pregnant or lactating women * Patients with infected wounds. * Life-threatening cardiac conductivity abnormality * Active malignancy * Women of childbearing age not using contraceptive measures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain | before to 30 minutes after treatment | by using a visual analogue thermometer (VAT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| local skin reaction | directly to 30 minutes after treatment | blister formation, itching |
| local skin temperature | before to 30 minutes after treatment | thermographic analysis |
| colour/pigmentation | before to 30 minutes after treatment | erythema, redness of the skin, by using a Dermaspectrometer |
| trans epidermal water loss | before to 30 minutes after treatment | barrier function of the skin by using TEWAmeter |
| reduction of the bacterial load | directly to 5 minutes after treatment | quantified with scrub wash method |
Countries
Netherlands
Outcome results
None listed