Cutaneous Microcirculation After Extracorporeal Shock Wave Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Extracorporeal Shock Wave Therapy in Cutaneous Microcirculation of Different Wounds

Conditions
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Burn Injury, Acute Wound, Chronic Wound, Burn Scar, Flap Disorder

Intervention / Treatment
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* Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
* Device: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria below 18 years of age wounds requiring artificial respiration, since consent for the study participation is unobtainable Exclusion Criteria Groups A, B, D, E, F, H: peripheral arterial occlusive disease vasculitis diabetes mellitus chronic kidney or liver disease cardiac dysfunction arterial hypo- or hypertension Anamnestic exclusion criteria ongoing immunosuppressive or chemotherapy treatment drug abuse systemic skin diseases systemic and local cortisone therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Second-Degree Burn<br>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. Intervention: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) | Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>* Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>|
| Experimental: Skin Excision (for Skin Graft)<br>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 must not be less than 1% of TBSA. Intervention: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) | Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>* Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>|
| Experimental: Chronic Wound<br>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. Intervention: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) | Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>* Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>|
| Active Comparator: Intact Skin<br>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. Intervention: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) | Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>* Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>|
| Experimental: Second-Degree Burn (repetitive)<br>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. Intervention: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) | Device: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>* Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>|
| Experimental: Skin Excision (for Skin Graft) (repetitive)<br>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 must not be less than 1% of TBSA. Intervention: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) | Device: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>* Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>|
| Experimental: Chronic Wound (repetitive)<br>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. Intervention: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) | Device: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>* Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>|
| Active Comparator: Intact Skin (repetitive)<br>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 A-C must be evident. Intervention: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) | Device: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>* Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>|
| Experimental: Hypertrophic burn scar<br>Group I (n=20): Consent-capable male and female patients ≥18 years of age suffering from a hypertrophic burn scar. Intervention: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) | Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>* Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>|
| Experimental: Hypertrophic burn scar (repetitive)<br>Group J (n=20): Consent-capable male and female patients ≥18 years of age suffering from a hypertrophic burn scar. Intervention: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) | Device: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>* Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>|
| Experimental: Flap<br>Group K (n=20): Consent-capable male and female patients ≥18 years of age who received a flap. Intervention: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) | Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>* Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>|
| Experimental: Flap (repetitive)<br>Group L (n=20): Consent-capable male and female patients ≥18 years of age who received a flap. Intervention: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) | Device: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>* Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in microcirculation (composite measure) | capillary blood flow [arbitrary units AU] capillary blood velocity [AU] tissue oxygen saturation [%] relative postcapillary venous filling pressure [AU] | Baseline and 1 minute post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in microcirculation (areolar measure) | tissue oxygen saturation [%] tissue hemoglobin index | Baseline, while and 1 minute post-dose |