Safety assessment of cold gas plasma on intact ski

Completed

• Conditions: burn wound infection; wound contamination; 10019815; 10040785

• Registration Number: NL-OMON47073
• Lead Sponsor: Vereniging Samenwerkende Brandwondencentra Nederland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

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

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety of plasma treatment: occurance of SAE and pain scores will be recorded.<br /><br>Plasma treatment is considere safe when in * 10% moderate SAE due to the<br /><br>treatment.<br /><br>Pain: a VAT score above 2 is considered as a cutoff value for SAE.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The effect of plasma treatment on TEWL, local skin temperature, colorimetry and<br /><br>bacterial load will be determined.</p><br>