Cold Plasma Jet kINPen Med Versus Best Practice Wound Dressings

NCT04965805 | Completed

• 1 other identifier: 6/6-2-19
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wounds

Keywords

Plasma; Dressings

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Wound size reduction and healing

  Day 42 ±2

Other Outcomes (5)

• Change Infection PGA Score

  Day 0 to Day 42 ±2

• Change ph of the wound

  Day 3 to Day 42 ± 2

• Change Exudate level

  Day 3 to Day 42 ± 2

Study Arms (2)

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.

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.

Device: Best practice wound dressings

Interventions

cold plasmaJet kINPen Med DEVICE

experimental, non-inferiority

Cold plasma jet

Best practice wound dressings DEVICE

comparative,

Best Practice wound dressings

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University Teaching Hospital, Feldkirch, Austria: lead
• neoplas Med: collaborator

Study Sites (1)

Federal Academic Teaching Hospital Feldkirch

Feldkirch, Vorarlberg, 6800, Austria

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primarius Professor Dr.

Model Details: The study is a double-center, two-armed, randomized, prospective, non-inferiority, clinical comparative trial.

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 16, 2021
• Study Start: February 4, 2019
• Primary Completion: March 1, 2021
• Study Completion: May 3, 2021
• Last Updated: July 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)