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Completed

NCT Number: NCT04965805

Cold Plasma Jet kINPen Med Versus Best Practice Wound Dressings

Within the treatment of chronic wounds the main objective is to analyze the wound healing properties with cold plasma (cold plasma jet kINPen® Med) compared to wound phase-adapted best practice wound dressings. Especially, close attention is paid to the development of the different phases of the chronic wounds until healing during the study.

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Key information

Conditions

Wounds Wounds and Injuries

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal Academic Teaching Hospital Feldkirch

Feldkirch, Vorarlberg, 6800, Austria

About this study

Cold plasma jet arm: Immediately after removal of the dressing, the wound will be cleaned with a physiological saline solution soaked swab. If > 30% fibrin coating or dry necrosis remaines after cleaning, debridement is required before treatment. The treatment scheme of the cold plasma jet will be applied in the following manner, quantity and frequency: Cold plasma is always applicated for 30 seconds/ cm^2 wound size. Wounds will be treated three times in the first week, twice in the second week and once per week in the following observation period. In case of locally infected ulcers, treatment will be performed 1x per day during the first week and afterwards in the same manner as in non-infected ulcers. After application of cold plasma, the wound will be covered with Adaptic perforated gauze and a non-active dressing. Dressing change will be performed after treatment and at least every 2nd day, on weekends every 3rd day; in the case of locally infected wounds, dressings will be changed daily. The application of cold plasma will be performed always by the examiner. Dressing changes beyond visits can also be performed by the general practitioner, a nursing service or by the participant him- or herself.

Best Practice treatment arm: Immediately after dressing removal, the wound will be cleaned with a physiological saline solution soaked swab. In case of locally infected wounds, an antiseptic will be used instead of the physiological saline solution. Subsequently, a wound phase-adapted primary dressing will be applied according to the experience of the practitioner and, if necessary, the wound will be covered with a secondary dressing according to the experience of the practitioner as well. In case of locally infected wounds, silver dressings can be applied. The dressing will be changed at least every 2nd day and on weekends every 3rd day; in case of locally infected wounds, dressings will be changed daily. Dressing changes beyond visits can also be performed by the general practitioner, a nursing service, or by the participant him- or herself.

In case of a venous leg ulcer, a modern compression system will be applied for compression in both study arms.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • For inclusion in the study, participants must meet the following criteria:
  • chronic wounds of any origin or wound phase, including locally infected chronic ulcers
  • wound size up to 20x10 cm
  • wounds without visible tendon or bone
  • participant age between 18 95 years

Exclusion criteria

  • • acute wounds
  • in case of multiple wounds, only one wound will be assigned as study wound
  • wounds with > 30 percentage necrotic eschar
  • pregnant or breastfeeding women or women of childbearing age
  • participants with intake of antibiotics within one week before the start of the enrollment
  • allergy or intolerance against a primary or secondary dressing
  • allergy or intolerance against cold plasma
  • participation in any other clinical trial up to one month prior to study enrollment

Treatment and study plan

cold plasmaJet kINPen Med

Device

experimental, non-inferiority

Best practice wound dressings

Device

comparative,

Primary outcomes

  1. Percentage of the Sum of Granulation Tissue on the Wound

    Time frame: Day 42 ±2

    At baseline (Day 0) and each subsequent visit, the total amount of granulation tissue of each wound will be documented as percentage of wound area. The entire circumference of the ulcer will be traced, then divided into four equal parts (one quadrant corresponding to 25 percentage), and the amount of granulation tissue will be measured using a ruler. The percentage corresponding to the amount will be determined mathematically.

Secondary outcomes

  1. Wound size reduction and healing

    Time frame: Day 42 ±2

    The dynamic of the wound size in cm^2 is measured by a digital automated system.

Other outcomes

  1. Change Infection PGA Score

    Time frame: Day 0 to Day 42 ±2

    At baseline (Day 0) and each subsequent visit, clinical signs of a local infection will be documented according to the Physician Global Assessment (PGA) Score:

    infection PGA 4: very strong infection PGA 3: strong infection PGA 2: moderate infection PGA 1: mild infection PGA 0: absent

  2. Change ph of the wound

    Time frame: Day 3 to Day 42 ± 2

    Prior to each dressing change, the pH value of the wound bed or the central wound fluid will be measured with an adjusted pH meter calibrated to pH 7.

  3. Change Exudate level

    Time frame: Day 3 to Day 42 ± 2

    The amount of wound exudate will be determined by the study practitioner and quantified on a scale from 0 to 4 at the below specified study visits:

    4: highly exudative 3: strong 2: moderate

    1: mild 0: absent

  4. Participant's Sensation of the Application of the Cold Plasma Jet

    Time frame: Day 3

    In the cold plasma jet arm, the participants will be asked to rate their sensation after the cold plasma treatment on a scale from 1 to 4:

    4 - very unpleasant (severe pain, burning sensation) 3 - uncomfortable 2 - no specific sensibility

    1 - pleasant feeling (e.g. cooling)

  5. Local tolerability

    Time frame: Day 35 ± 2

    During each dressing change after Day 0, the tolerability of the treatment substances used will be evaluated according to the following parameters:

    • no problem (e. g., no maceration, wound deterioration or blisters)
    • emergence or exacerbation of
    • erythema
    • maceration
    • blisters
    • congestion of exudate

Sponsors and collaborators

Lead sponsor

Federal University Teaching Hospital, Feldkirch, Austria

Other

Collaborators

  • neoplas Med

Registry information

Official study title

The Treatment of Chronic Wounds With the Cold Plasma Jet kINPen® Med Versus Best Practice Wound Dressings: a Multicenter, 2-Armed, Randomized, Open-label, Prospective, Non-inferiority Clinical Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2021
Registry last updated
Jul 16, 2021

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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