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| Name | Class |
|---|---|
| neoplas Med | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cold plasma jet | Experimental | 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. |
|
| Best Practice wound dressings | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cold plasmaJet kINPen Med | Device | experimental, non-inferiority |
| |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change Infection PGA Score | 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 | Day 0 to Day 42 ±2 |
Inclusion Criteria:
For inclusion in the study, participants must meet the following criteria:
Exclusion Criteria:
• acute wounds
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal Academic Teaching Hospital Feldkirch | Feldkirch | Vorarlberg | 6800 | Austria |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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The study is a double-center, two-armed, randomized, prospective, non-inferiority, clinical comparative trial.
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| Best practice wound dressings |
| Device |
comparative, |
|
| Change ph of the wound |
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. |
| Day 3 to Day 42 ± 2 |
| Change Exudate level | 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 | Day 3 to Day 42 ± 2 |
| Participant's Sensation of the Application of the Cold Plasma Jet | 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) | Day 3 |
| Local tolerability | During each dressing change after Day 0, the tolerability of the treatment substances used will be evaluated according to the following parameters:
| Day 35 ± 2 |