Cold atmospheric plasma (CAP) for reduction of bacteria in chronic skin wounds – plasma care study

Not Applicable

Completed

• Conditions: Chronic infected wounds; Infections and Infestations

• Registration Number: ISRCTN98384076
• Lead Sponsor: Terraplasma medical GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-15
• Study Completion: 2020-05-04
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 11

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure:<br> 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.<br><br> Previous primary outcome measure:<br> 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.<br> 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.<br>

Secondary Outcome Measures

Name	Time	Method
<br> Followed for a maximum of 12 weeks:<br> 1. Intensity of pain assessed with standardized visual analogue scale at each treatment session<br> 2. Assessment of safety by means of reported SAEs and AEs of special interest<br>