Acute Wound, Burn Injury, Burn Scar, Chronic Wound, Flap Disorder
Conditions
Brief summary
In plastic and reconstructive surgery, treatment strategies of second-degree burns, superficial wounds, hypertrophic burn scars, flaps and chronic wounds aim at reducing infection and improving microcirculation. Although previous studies indicate that extracorporeal shock wave therapy (ESWT) 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 extracorporeal shock wave therapy on second-degree burns, superficial wounds, hypertrophic burn scars, flaps and chronic wounds in a human in-vivo setting for the first time.
Interventions
Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
DEVICERepetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Sponsors
University Hospital Schleswig-Holstein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
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 scar. * Group J (n=20): Consent-capable male and female patients ≥18 years of age suffering from a hypertrophic burn scar. * Group K (n=20): Consent-capable male and female patients ≥18 years of age who received a flap. * Group L (n=20): Consent-capable male and female patients ≥18 years of age who 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