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OpenTrials
Completed

NCT Number: NCT03007264

Cold Plasma for Wound Treatment, Safety Study

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Association of Dutch Burn Centres

Beverwijk, North Holland, 1942 LE, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cold Atmospheric Plasma

Device

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

Primary outcomes

  1. pain

    Time frame: before to 30 minutes after treatment

    by using a visual analogue thermometer (VAT)

Secondary outcomes

  1. local skin reaction

    Time frame: directly to 30 minutes after treatment

    blister formation, itching

  2. local skin temperature

    Time frame: before to 30 minutes after treatment

    thermographic analysis

  3. colour/pigmentation

    Time frame: before to 30 minutes after treatment

    erythema, redness of the skin, by using a Dermaspectrometer

  4. trans epidermal water loss

    Time frame: before to 30 minutes after treatment

    barrier function of the skin by using TEWAmeter

  5. reduction of the bacterial load

    Time frame: directly to 5 minutes after treatment

    quantified with scrub wash method

Sponsors and collaborators

Lead sponsor

Association of Dutch Burn Centres

Other

Collaborators

  • Eindhoven University of Technology

Registry information

Official study title

Safety Assessment of Cold Gas Plasma on Intact Skin

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 2, 2017
Registry last updated
Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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