Wounds Clinical Trial
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
NCT number | NCT04965805 |
Other study ID # | 6/6-2-19 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 4, 2019 |
Est. completion date | May 3, 2021 |
Verified date | July 2021 |
Source | Federal University Teaching Hospital, Feldkirch, Austria |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 78 |
Est. completion date | May 3, 2021 |
Est. primary completion date | March 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 95 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Federal Academic Teaching Hospital Feldkirch | Feldkirch | Vorarlberg |
Lead Sponsor | Collaborator |
---|---|
Federal University Teaching Hospital, Feldkirch, Austria | neoplas Med |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 of erythema maceration blisters congestion of exudate |
Day 35 ± 2 | |
Primary | 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 | Wound size reduction and healing | The dynamic of the wound size in cm^2 is measured by a digital automated system. | Day 42 ±2 |
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