Cold Plasma Jet kINPen Med Versus Best Practice Wound Dressings
Condition: Wounds
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): cold plasmaJet kINPen Med; Best practice wound dressings
Intervention type(s): Device; Device
Intervention description(s): experimental, non-inferiority; comparative,
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is a double-center, two-armed, randomized, prospective, non-inferiority, clinical comparative trial.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Plasma; Dressings