Cold Plasma Jet kINPen Med Versus Best Practice Wound Dressings
Wounds
About this trial
This is an interventional treatment trial for Wounds focused on measuring Plasma, Dressings
Eligibility Criteria
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
Sites / Locations
- Federal Academic Teaching Hospital Feldkirch
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Cold plasma jet
Best Practice wound dressings
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.