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Safety assessment of cold gas plasma on intact skin

Safety assessment of cold gas plasma on intact skin - Cold plasma on skin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47073
Enrollment
25
Registered
2017-05-29
Start date
2018-06-08
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

burn wound infection wound contamination

Interventions

Volunteers will be treated once with cold gas plasma.

Sponsors

Vereniging Samenwerkende Brandwondencentra Nederland
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -18 years or older, -have completed informed consent forms; -able and willing to comply with the research protocol; -no language barrier

Exclusion criteria

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

MeasureTime frame
Safety of plasma treatment: occurance of SAE and pain scores will be recorded. Plasma treatment is considere safe when in * 10% moderate SAE due to the treatment. Pain: a VAT score above 2 is considered as a cutoff value for SAE.

Secondary

MeasureTime frame
The effect of plasma treatment on TEWL, local skin temperature, colorimetry and bacterial load will be determined.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)