Cold Plasma for Wound Treatment, Safety Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety Assessment of Cold Gas Plasma on Intact Skin

Conditions
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Intact Skin, Contaminant Given to Patient

Intervention / Treatment
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* Device: Cold Atmospheric Plasma


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAP treated<br>volar arm will be treated with cold atmospheric plasma. | Device: Cold Atmospheric Plasma<br>* CAP will be applied on one volar arm of volunteers for a total of 2 minutes.<br>|
| Experimental: CAP on bacteria<br>volar arm with bacteria will be treated with cold atmospheric plasma. | Device: Cold Atmospheric Plasma<br>* CAP will be applied on one volar arm of volunteers for a total of 2 minutes.<br>|
| No Intervention: no CAP on bacteria<br>volar arm with bacteria will not be treated with cold atmospheric plasma. Sham comparator for measurements of skin parameters TEWL, temperature and bacterial load. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | by using a visual analogue thermometer (VAT) | before to 30 minutes after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local skin reaction | blister formation, itching | directly to 30 minutes after treatment | 
| local skin temperature | thermographic analysis | before to 30 minutes after treatment | 
| colour/pigmentation | erythema, redness of the skin, by using a Dermaspectrometer | before to 30 minutes after treatment | 
| trans epidermal water loss | barrier function of the skin by using TEWAmeter | before to 30 minutes after treatment | 
| reduction of the bacterial load | quantified with scrub wash method | directly to 5 minutes after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cold atmospheric plasma, pain, bacteria, skin parameters