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Cold Plasma for Wound Treatment, Safety Study

This study is not yet open for participant recruitment.
Verified December 2016 by Association of Dutch Burn Centres
Sponsor:
ClinicalTrials.gov Identifier:
NCT03007264
First Posted: January 2, 2017
Last Update Posted: January 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Eindhoven University of Technology
Information provided by (Responsible Party):
Association of Dutch Burn Centres
  Purpose
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.

Condition Intervention Phase
Intact Skin Contaminant Given to Patient Device: Cold Atmospheric Plasma Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Assessment of Cold Gas Plasma on Intact Skin

Further study details as provided by Association of Dutch Burn Centres:

Primary Outcome Measures:
  • pain [ Time Frame: before to 30 minutes after treatment ]
    by using a visual analogue thermometer (VAT)


Secondary Outcome Measures:
  • local skin reaction [ Time Frame: directly to 30 minutes after treatment ]
    blister formation, itching

  • local skin temperature [ Time Frame: before to 30 minutes after treatment ]
    thermographic analysis

  • colour/pigmentation [ Time Frame: before to 30 minutes after treatment ]
    erythema, redness of the skin, by using a Dermaspectrometer

  • trans epidermal water loss [ Time Frame: before to 30 minutes after treatment ]
    barrier function of the skin by using TEWAmeter

  • reduction of the bacterial load [ Time Frame: directly to 5 minutes after treatment ]
    quantified with scrub wash method


Estimated Enrollment: 25
Study Start Date: February 2017
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CAP treated
volar arm will be treated with cold atmospheric plasma.
Device: Cold Atmospheric Plasma
CAP will be applied on one volar arm of volunteers for a total of 2 minutes.
Experimental: CAP on bacteria
volar arm with bacteria will be treated with cold atmospheric plasma.
Device: Cold Atmospheric Plasma
CAP will be applied on one volar arm of volunteers for a total of 2 minutes.
No Intervention: 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.

Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03007264


Contacts
Contact: Bouke Boekema, PhD +31 251 27 55 03 bboekema@burns.nl
Contact: Marlies kobesen +31 251 27 55 00 mkobesen@burns.nl

Sponsors and Collaborators
Association of Dutch Burn Centres
Eindhoven University of Technology
Investigators
Principal Investigator: Esther Middelkoop, PhD Red Cross Hospital
  More Information

Publications:
Responsible Party: Association of Dutch Burn Centres
ClinicalTrials.gov Identifier: NCT03007264     History of Changes
Other Study ID Numbers: NBS 14.200-CAP1
NL52211.094.16 ( Other Identifier: ABR )
First Submitted: December 23, 2016
First Posted: January 2, 2017
Last Update Posted: January 2, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Association of Dutch Burn Centres:
cold atmospheric plasma
pain
bacteria
skin parameters