Acute Wound, Burn Injury, Burn Scar, Chronic Wound
Conditions
Brief summary
In plastic and reconstructive surgery, treatment strategies of second-degree burns, superficial wounds, burn scars, flaps and chronic wounds aim at reducing infection and improving microcirculation. Although previous studies indicate that Plasma Therapy can accelerate wound healing, only a few studies focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of Plasma Therapy on second-degree burns, superficial wounds, burn scars, flaps and chronic wounds in a human in-vivo setting for the first time.
Interventions
DEVICEPlasma Therapy (PlasmaDerm)
Plasma Therapy (PlasmaDerm)
DEVICERepetitive Plasma Therapy (repetitive PlasmaDerm)
Repetitive Plasma Therapy (Repetitive PlasmaDerm)
Sponsors
University Hospital Schleswig-Holstein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Group A (n=20): Consent-capable male and female patients ≥18 years of age who have sustained a second-degree burn on ≥1% and ≤30% of the surface of the body. Group B (n=20): Consent-capable male and female patients ≥18 years of age who require a skin excision for the purpose of a skin graft. The minimal size of the skin-graft donor site must not be less than 1% of TBSA. Group C (n=20): Consent-capable male and female patients ≥18 years of age suffering from a wound that has not yet healed ≥3 weeks. The minimal size of the wound site must not be less than 1% of TBSA. Group D (n=20): Consent-capable healthy male and female probands ≥18 years of age serving as sham group. None of the the criteria of groups A-C must be evident. No soft tissue injury must be evident. Group E (n=20): Consent-capable male and female patients ≥18 years of age who have sustained a second-degree burn on ≥1% and ≤30% of the surface of the body. Group F (n=20): Consent-capable male and female patients ≥18 years of age who require a skin excision for the purpose of a skin graft. The minimal size of the skin-graft donor site must not be less than 1% of TBSA. Group G (n=20): Consent-capable male and female patients ≥18 years of age suffering from a wound that has not yet healed ≥3 weeks. The minimal size of the wound site must not be less than 1% of TBSA. Group H (n=20): Consent-capable healthy male and female probands ≥18 years of age serving as sham group. None of the the criteria of groups E-G must be evident. No soft tissue injury must be evident. Group I (n=20): Consent-capable male and female patients ≥18 years of age suffering from a hypertrophic burn wound. Group J (n=20): Consent-capable male and female patients ≥18 years of age suffering from a hypertrophic burn wound. Group K (n=20): Consent-capable male and female patients ≥18 years of age received a flap. Group L (n=20): Consent-capable male and female patients ≥18 years of age received a flap.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in microcirculation (composite measure) | Baseline and 1 minute post-dose | * capillary blood flow \[arbitrary units AU\] * capillary blood velocity \[AU\] * tissue oxygen saturation \[%\] * relative postcapillary venous filling pressure \[AU\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in microcirculation (areolar measure) | Baseline, while and 1 minute post-dose | * tissue oxygen saturation \[%\] * tissue hemoglobin index |
Countries
Germany
Outcome results
None listed