Chronic infected wounds Infections and Infestations
Conditions
Interventions
Each study patient will serve as his/her own control by performing cold atmospheric plasma (CAP) treatment and placebo treatment on two different comparable wound locations within the same treatment s
Sponsors
Terraplasma medical GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 20/07/2020: 1. Age = 18 years 2. Chronic (existing >8 weeks) treatable skin wound(s) of one or more of the following origins: arterial, venous, infectious, diabetic, neuropathic, traumatic 3. Chronic skin wound(s) colonised with bacteria, as confirmed by CFU count in nitrocellulose filter culture 4. Signed informed consent 5. Two comparable treatment sites, resulting of chronic, colonized skin wounds: 5.1 Two wounds each of a size of at least approx. 1.5 cm x 1.5 cm, or 5.2 One separable wound of a size of at least approx. 1.5 cm width and at least approx. 6 cm length Previous participant inclusion criteria as 0f 11/07/2019: 1. Age = 18 years 2. Chronic (existing >8 weeks) treatable skin wound(s) of one or more of the following origins: arterial, venous, infectious, diabetic, neuropathic, traumatic 3. Chronic skin wound(s) colonised with bacteria, as confirmed by CFU count in nitrocellulose filter culture 4. Signed informed consent 5. Two comparable treatment sites, resulting of chronic, colonized skin wounds: 5.1 Two wounds each of a size of at least approx. 2 cm x 2 cm, or 5.2 One separable wound of a size of at least approx. 2 cm width and at least approx. 8 cm length Previous participant inclusion criteria: 1. Age = 18 years 2. Chronic (existing >8 weeks) treatable skin wound(s) of one or more of the following origins: arterial, venous, infectious, diabetic, neuropathic, traumatic 3. Chronic skin wound(s) colonised with bacteria, as confirmed by CFU count in nitrocellulose filter culture 4. Signed informed consent 5. 2 comparable treatment sites, each of a size of at least approx. 2 cm x 2 cm (2 wounds OR one large separable wound)
Exclusion criteria
Exclusion criteria: 1. Wounds with tumor origin 2. Wounds of vasculitic genesis 3. Pyoderma gangrenosum 4. Drug abuse or clinically manifest alcohol abuse 5. Participation in another clinical trial, either within the past 2 months or still ongoing 6. Previous participation in plasma care study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure: Reduction of bacterial load in treated wounds: The difference between count of colony forming units (CFUs) in nitrocellulose contact smear filter culture immediately before and after study treatment, expressed as percentage of CFUs immediately before each study treatment. Previous primary outcome measure: 1. Reduction of bacterial load in treated wounds: The difference between count of colony forming units (CFUs) per cm2 in nitrocellulose filter culture immediately before and after study treatment, expressed as percentage of CFUs per cm2 immediately before each study treatment session. 2. Time to optimal reduction of bacterial load: The timepoint after which the following reduction of bacterial load is smaller than 10% of the CFUs per cm² immediately before each study treatment session. | — |
Secondary
| Measure | Time frame |
|---|---|
| Followed for a maximum of 12 weeks: 1. Intensity of pain assessed with standardized visual analogue scale at each treatment session 2. Assessment of safety by means of reported SAEs and AEs of special interest | — |
Countries
Germany
Outcome results
None listed