Cold Plasma Jet kINPen Med Versus Best Practice Wound Dressings

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Wounds

Intervention / Treatment
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* Device: cold plasmaJet kINPen Med
* Device: Best practice wound dressings


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a double-center, two-armed, randomized, prospective, non-inferiority, clinical comparative trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cold plasma jet<br>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. | Device: cold plasmaJet kINPen Med<br>* experimental, non-inferiority<br>|
| Active Comparator: Best Practice wound dressings<br>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. | Device: Best practice wound dressings<br>* comparative,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of the Sum of Granulation Tissue on the Wound | 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. | Day 42 ±2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound size reduction and healing | The dynamic of the wound size in cm^2 is measured by a digital automated system. | Day 42 ±2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plasma, Dressings