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| ID | Type | Description | Link |
|---|---|---|---|
| NL52211.094.16 | Other Identifier | ABR |
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| Name | Class |
|---|---|
| Eindhoven University of Technology | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAP treated | Experimental | volar arm will be treated with cold atmospheric plasma. |
|
| CAP on bacteria | Experimental | volar arm with bacteria will be treated with cold atmospheric plasma. |
|
| no CAP on bacteria | No Intervention | volar arm with bacteria will not be treated with cold atmospheric plasma. Sham comparator for measurements of skin parameters TEWL, temperature and bacterial load. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold Atmospheric Plasma | Device | CAP will be applied on one volar arm of volunteers for a total of 2 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| pain | by using a visual analogue thermometer (VAT) | before to 30 minutes after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| local skin reaction | blister formation, itching | directly to 30 minutes after treatment |
| local skin temperature | thermographic analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esther Middelkoop, PhD | Red Cross Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Association of Dutch Burn Centres | Beverwijk | North Holland | 1942 LE | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26944583 | Result | Kisch T, Schleusser S, Helmke A, Mauss KL, Wenzel ET, Hasemann B, Mailaender P, Kraemer R. The repetitive use of non-thermal dielectric barrier discharge plasma boosts cutaneous microcirculatory effects. Microvasc Res. 2016 Jul;106:8-13. doi: 10.1016/j.mvr.2016.02.008. Epub 2016 Mar 2. | |
| 24666170 | Result | Brehmer F, Haenssle HA, Daeschlein G, Ahmed R, Pfeiffer S, Gorlitz A, Simon D, Schon MP, Wandke D, Emmert S. Alleviation of chronic venous leg ulcers with a hand-held dielectric barrier discharge plasma generator (PlasmaDerm((R)) VU-2010): results of a monocentric, two-armed, open, prospective, randomized and controlled trial (NCT01415622). J Eur Acad Dermatol Venereol. 2015 Jan;29(1):148-55. doi: 10.1111/jdv.12490. Epub 2014 Mar 25. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 16, 2021 | |
| Reset | Mar 8, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 16, 2021 | Mar 8, 2021 |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |