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Trial registered on ANZCTR


Registration number
ACTRN12622000948796p
Ethics application status
Submitted, not yet approved
Date submitted
30/06/2022
Date registered
5/07/2022
Date last updated
5/07/2022
Date data sharing statement initially provided
5/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of non-thermal plasma on burn wounds: a pilot study
Scientific title
The effects of non-thermal plasma on burn wounds: a pilot study
Secondary ID [1] 307460 0
340/22
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burns 326851 0
Studies of infection and infectious agents 326852 0
Condition category
Condition code
Injuries and Accidents 324063 324063 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Terraplasma Medical GmbH has developed and commercialised a hand-held non-thermal plasma device (Plasma care) for use in chronic wounds. The application of this device in burns has yet to be elucidated.
The aim of this pilot study is to examine the feasibility, acceptability and initial efficacy of this device in burn wounds. At total of nine inpatients with <10% total body surface area burns will be recruited. A section of the burn will be treated with non-thermal plasma with the rest treated with standard therapy. Wounds will be assessed and treated daily, with outcomes compared with standard treatment.

Individuals who undergo inpatient management of their burns will be invited to participate in this study. Nine inpatients with a single or multiple burn or donor site between 1-10% TBSA, will be recruited to enable within-person comparison where both NTP and standard topical treatments are applied to different areas of the same participant.
The decision over location will be determined by the investigators, but if the burns are bilateral legs, then 1 leg will be treated with NTP the other with standard therapy. The site of NTP will be marked with permanent marker to ensure that the treatment area is identifiable.

It is anticipated that participants will undergo daily treatments with 3-minute applications of NTP, and standard therapy. A trained burn doctor or registered nurse will use the machine to deliver the therapy. The device is placed on the burn, separated by a spacer, on switching the device on it generates a plasma field containing reactive oxygen species, which is applied to the wound. The device is a start/stop, and does not allow variation in strength of the plasma generated. Additional technical information can be found on the product information.
(2c) Wound healing and evidence of wound infection will be assessed daily, but reviewed on day 5 if it has not healed earlier. If the burn has not healed or remains infected despite 5 days of NTP therapy, participants treatment will revert to standard care. NTP treatment is only required during the acute inpatient management of their unhealed burn wound; therefore, participants will not require post-trial access to the non-thermal plasma treatment.
Steps for topical treatment of burn wound
1. Patients are pre-medicated with analgesia/anxiolysis as required
2. Existing dressing will be removed
3. Burn wound/donor is washed with a soap free wash
a. Review of wound/photos taken
4. Topical antibacterial treatment applied to burn either NTP or standard therapy (antibacterial soak or other cream/gels determined by clinical staff)
5. Sterile dressing applied

NTP treatment is only required during the acute inpatient management of their unhealed burn wound; therefore, participants will not require post-trial access to the non-thermal plasma treatment. Adherence will be assessed using daily data collection of the effects of the NTP on the burn. Longer term follow up for 2 years will occur inline with standard post -burn follow up and care.
Intervention code [1] 323916 0
Treatment: Devices
Comparator / control treatment
Standard wound care.
In addition to the commencement of antibiotics for the systemic treatment of infected burns, the standard topical treatment consists of the following steps:
Steps for topical treatment of burn wound
1. Patients are pre-medicated with analgesia/anxiolysis as required
2. Existing dressing will be removed
3. Burn wound/donor is washed with a soap free wash
a. Review of wound/photos taken
4. Topical antibacterial treatment applied to burn (antibacterial soak or other cream/gels determined by clinical staff)
5. Sterile dressing applied

The type of dressing and or antibacterial treatment is based on clinical opinion by the treating physician and nursing staff.
Control group
Active

Outcomes
Primary outcome [1] 331851 0
Speed of wound healing of NTP treated burn compared with standard wound care over the course of in patient stay. Outcome based on clinical opinion. (better, same or worse) will be recorded on the daily treatment survey. Overall quality of healing will be examined over longer term during clinical outpatient follow up. (better, same or worse).
Timepoint [1] 331851 0
Initial assessment after 5 days of treatment, then follow up post healing at 6 weeks, 3 months, 12 and 24 months.
Primary outcome [2] 331884 0
Speed of resolution of wound infection comparing non-thermal plasma vs. standard topical treatments. Outcome based on clinical opinion. (better, same or worse) will be recorded on the daily treatment survey.
Timepoint [2] 331884 0
Day 5 of inpatient treatment.
Secondary outcome [1] 411394 0
Feasibility will be examined by feedback responses of staff delivering the NTP therapy, specifically focused on their impression of the time and intensity required to prepare, deliver and clean the NTP equipment, whether they perceive this technology as being useful in the treatment of burn wounds.
Timepoint [1] 411394 0
Initial assessment after 5 days of treatment, then follow up post healing at 6 weeks, 3 months, 12 and 24 months.
Secondary outcome [2] 411578 0
Acceptability will be assessed by completion of a survey at the end of each dressing change from participants, Specifically:

Patient:
1. Pain - score 1-10/10 with NTP treatment compared with standard therapy
2. Skin breakdown
3. Adverse effects - free text if identified. - Intolerance to temperature generated
Timepoint [2] 411578 0
Daily during in-patient treatment for 5 days
Secondary outcome [3] 411579 0
Acceptability will be assessed by completion of a survey at the end of each dressing change from observation by staff delivering NTP therapy, Specifically:
1. Ease of application
2. time required for treatment, compared with standard therapy
3. Cleaning of equipment time
4. Number of disposables required
Timepoint [3] 411579 0
Daily during 5 day inpatient treatment

Eligibility
Key inclusion criteria
• Patients must be able to provide consent to treatment, and engage with follow up, including with clinical photography
• Patients require in-patient management of their wound, for at least 1 dressing change
• Moderate (>1-10%TBSA) or multiple burns or donor sites to enable within person trials of NTP vs. Standard treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Small burns or donor sites (<=1%TBSA) that would not facilitate separate treatment areas
• Burns on the face, making the participant identifiable
• Burns on the genitals/perineum
• Planned outpatient treatment of the burn
• Patients with large burns (>10%TBSA)
• Patients unable to participate in follow up

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Nil
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Within person treatment. Patients receive both standard care and non thermal plasma on different part of the burns to assess for healing.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Non-parametric analysis. However, as pilot study only, main outcome is to assess benefit for larger trial.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/07/2022
Actual
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
25/06/2025
Actual
Sample size
Target
9
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22656 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 37932 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 311732 0
Hospital
Name [1] 311732 0
Alfred Hospital - Research seed funding grant
Country [1] 311732 0
Australia
Funding source category [2] 311734 0
Charities/Societies/Foundations
Name [2] 311734 0
ANZBA early career research grant
Country [2] 311734 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Rd Melbourne Vic 3004
Country
Australia
Secondary sponsor category [1] 313194 0
None
Name [1] 313194 0
Address [1] 313194 0
Country [1] 313194 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311180 0
Alfred Health Ethics Committee
Ethics committee address [1] 311180 0
55 Commercial Rd Melbourne Vic 3004
Ethics committee country [1] 311180 0
Australia
Date submitted for ethics approval [1] 311180 0
06/07/2022
Approval date [1] 311180 0
Ethics approval number [1] 311180 0

Summary
Brief summary
Non-thermal plasma (NTP) is a relatively new technology that generates charged molecules (ions, and reactive oxygen species) at safe working temperatures of 35-40'C. The charged molecules (free electrons and reactive oxygen species such as Ozone) interact with microbial cellular structures such as DNA and proteins causing intracellular deactivation and injury, which induces cellular death. This cellular destruction occurs independently of any antibiotic process, thereby adding to treatment options for multi-drug resistant bacteria.
Based on these findings non-thermal plasma has been applied in a variety of commercial fields including water treatment, sterilisation, and healthcare. Terraplasma Medical GmbH has developed and commercialised a hand-held non-thermal plasma device (Plasma care) for use in chronic wounds. The application of this device in burns has yet to be elucidated.
The aim of this pilot study is to examine the feasibility, acceptability and initial efficacy of this device in burn wounds. At total of nine inpatients with <10% total body surface area burns will be recruited. A section of the burn will be treated with NTP with the rest treated with standard therapy. Wounds will be assessed and treated daily, with outcomes compared with standard treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120234 0
Dr Guy Sheahan
Address 120234 0
Alfred Hospital
55 Commercial Rd Melbourne Vic 3004
Country 120234 0
Australia
Phone 120234 0
+61 39076 2000
Fax 120234 0
Email 120234 0
g.sheahan@alfred.org.au
Contact person for public queries
Name 120235 0
Dr Guy Sheahan
Address 120235 0
Alfred Hospital
55 Commercial Rd Melbourne Vic 3004
Country 120235 0
Australia
Phone 120235 0
+61 390762000
Fax 120235 0
Email 120235 0
g.sheahan@alfred.org.au
Contact person for scientific queries
Name 120236 0
Dr Guy Sheahan
Address 120236 0
Alfred Hospital
55 Commercial Rd Melbourne Vic 3004
Country 120236 0
Australia
Phone 120236 0
+61 390762000
Fax 120236 0
Email 120236 0
g.sheahan@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Limited data collected for the purposes of this small pilot study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.