Cold Plasma for Wound Treatment, Safety Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-18

Study Completion Date

2018-07-26

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.

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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.

Conditions

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Intact Skin Contaminant Given to Patient

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CAP treated

volar arm will be treated with cold atmospheric plasma.

Group Type EXPERIMENTAL

Cold Atmospheric Plasma

Intervention Type DEVICE

CAP will be applied on one volar arm of volunteers for a total of 2 minutes.

CAP on bacteria

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

Group Type EXPERIMENTAL

Cold Atmospheric Plasma

Intervention Type DEVICE

CAP will be applied on one volar arm of volunteers for a total of 2 minutes.

no CAP on bacteria

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cold Atmospheric Plasma

CAP will be applied on one volar arm of volunteers for a total of 2 minutes.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes