None listed
Conditions
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.
Interventions
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
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.
Sponsors
Alfred Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed