WoundsNCT04965805
Cold Plasma Jet kINPen Med Versus Best Practice Wound Dressings
A study testing cold plasmaJet kINPen Med and Best practice wound dressings in people with Wounds, run by Federal University Teaching Hospital, Feldkirch, Austria at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Wounds
- What is being tested?
- cold plasmaJet kINPen Med and Best practice wound dressings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteAustria
- Study dates
- 4 Feb 2019to 3 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Federal Academic Teaching Hospital Feldkirch
Feldkirch, Vorarlberg, 6800
About this study
Official title: 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.
Read the 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.
- Conditions
- Wounds
- Being tested
- cold plasmaJet kINPen Med, Best practice wound dressings
- Keywords
- Plasma, Dressings
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold plasmaJet kINPen MedDevice
experimental, non-inferiority
Best practice wound dressingsDevice
comparative,
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: cold plasmaJet kINPen Med |
| 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. Receives: Device: Best practice wound dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 42 ±2
Secondary outcomes (1)
Wound size reduction and healing
The dynamic of the wound size in cm^2 is measured by a digital automated system.
Measured: Day 42 ±2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start4 Feb 2019
- Primary completion1 Mar 2021
- Study completion3 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a double-center, two-armed, randomized, prospective, non-inferiority, clinical comparative trial.
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University Teaching Hospital, Feldkirch, Austria
- Sponsor type
- University, hospital or other
- Collaborators
- neoplas Med
- Responsible party
- Principal investigator, Robert Strohal, Federal University Teaching Hospital, Feldkirch, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965805
- Sponsor's protocol ID
- 6/6-2-19
- Status last verified
- Jul 2021
- First submitted
- 5 Jul 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04965805
- Acronym / sponsor ID
- 6/6-2-19
- Conditions
- Wounds
- Keywords
- Plasma, Dressings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Federal University Teaching Hospital, Feldkirch, AustriaUniversity, hospital or other
- Collaborators
- neoplas Med
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a double-center, two-armed, randomized, prospective, non-inferiority, clinical comparative trial.
| Arm | Type | Receives |
|---|---|---|
| Cold plasma jet | Experimental | Device: cold plasmaJet kINPen MedThe 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 | Device: Best practice wound dressingsImmediately 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. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- For inclusion in the study, participants must meet the following criteria:
Key exclusion criteria (8 listed)
- • acute wounds
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cold plasmaJet kINPen Medexperimental, non-inferiority | Device | Cold plasma jet |
| Best practice wound dressingscomparative, | Device | Best Practice wound dressings |
Primary outcome
Percentage of the Sum of Granulation Tissue on the Wound
Time frame: Day 42 ±2
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.
1 secondary outcome
Wound size reduction and healing
Time frame: Day 42 ±2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Wounds
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cold plasmaJet kINPen Med and Best practice wound dressings in people with Wounds, run by Federal University Teaching Hospital, Feldkirch, Austria at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of the Sum of Granulation Tissue on the Wound (time frame: Day 42 ±2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.