Cold Plasma for Wound Treatment, Safety Study

Association of Dutch Burn Centres

Status and phase: Completed; Phase 1

Conditions: Intact Skin; Contaminant Given to Patient

Treatments: Device: Cold Atmospheric Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT03007264

NBS 14.200-CAP1

NL52211.094.16 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

CAP treated

Experimental group

Description:

volar arm will be treated with cold atmospheric plasma.

Treatment:

Device: Cold Atmospheric Plasma

CAP on bacteria

Experimental group

Description:

volar arm with bacteria will be treated with cold atmospheric plasma.

Treatment:

Device: Cold Atmospheric Plasma

no CAP on bacteria

No Intervention group

Description:

volar arm with bacteria will not be treated with cold atmospheric plasma. Sham comparator for measurements of skin parameters TEWL, temperature and bacterial load.