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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Second-Degree Burn | Experimental | 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) |
|
| Skin Excision (for Skin Graft) | Experimental | 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) |
|
| Chronic Wound | Experimental | 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) |
|
| Intact Skin | Active Comparator | 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) | Device | Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in microcirculation (composite measure) |
| Baseline and 1 minute post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change in microcirculation (areolar measure) |
| Baseline, while and 1 minute post-dose |
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Inclusion Criteria:
Exclusion Criteria:
General exclusion criteria
Exclusion Criteria Groups A, B, D, E, F, H:
Anamnestic exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Kisch, MD | University Hospital Schleswig-Holstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Schleswig-Holstein | Lübeck | Schleswig-Holstein | 23538 | Germany |
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| Second-Degree Burn (repetitive) | Experimental | 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) |
|
| Skin Excision (for Skin Graft) (repetitive) | Experimental | 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) |
|
| Chronic Wound (repetitive) | Experimental | 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) |
|
| Intact Skin (repetitive) | Active Comparator | 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) |
|
| Hypertrophic burn scar | Experimental | 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) |
|
| Hypertrophic burn scar (repetitive) | Experimental | 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) |
|
| Flap | Experimental | 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) |
|
| Flap (repetitive) | Experimental | 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) |
|
| Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) | Device | Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) |
|
| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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