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.

Study Overview

• Status: Completed
• Conditions: Wounds
• Intervention / Treatment: Device: cold plasmaJet kINPen Med; Device: Best practice wound dressings

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vorarlberg
    • Feldkirch, Vorarlberg, Austria, 6800
      • Federal Academic Teaching Hospital Feldkirch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cold plasma jet; 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; experimental, non-inferiority
Active Comparator: Best Practice wound dressings; 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; comparative,

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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
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: no problem (e. g., no maceration, wound deterioration or blisters); emergence or exacerbation oferythemamacerationblisterscongestion of exudate	Day 35 ± 2

Collaborators and Investigators

• Sponsor: Federal University Teaching Hospital, Feldkirch, Austria
• Collaborators: neoplas Med

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2019
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): May 3, 2021

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Plasma; Dressings
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 6/6-2-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No