Cold Plasma Jet kINPen Med Versus Best Practice Wound Dressings

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

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.

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.

The study is a double-center, two-armed, randomized, prospective, non-inferiority, clinical comparative trial.

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.

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.

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.

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

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.

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

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)

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

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