Cutaneous Microcirculation After Extracorporeal Shock Wave Therapy

University Hospital Schleswig-Holstein (UKSH)

Status: Completed

Conditions: Acute Wound; Chronic Wound; Flap Disorder; Burn Scar; Burn Injury

Treatments: Device: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave); Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Study type: Interventional

Funder types: Other

Identifiers

NCT02417779

14-266-1

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

240 participants in 12 patient groups

Second-Degree Burn

Experimental group

Description:

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)

Treatment:

Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Skin Excision (for Skin Graft)

Experimental group

Description:

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)

Treatment:

Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Chronic Wound

Experimental group

Description:

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)

Treatment:

Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Intact Skin

Active Comparator group

Description:

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)

Treatment:

Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Second-Degree Burn (repetitive)

Experimental group

Description:

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)

Treatment:

Device: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Skin Excision (for Skin Graft) (repetitive)

Experimental group

Description:

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)

Treatment:

Device: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Chronic Wound (repetitive)

Experimental group

Description:

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)

Treatment:

Device: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Intact Skin (repetitive)

Active Comparator group

Description:

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)

Treatment:

Device: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Hypertrophic burn scar

Experimental group

Description:

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)

Treatment:

Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Hypertrophic burn scar (repetitive)

Experimental group

Description:

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)

Treatment:

Device: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Flap

Experimental group

Description:

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)

Treatment:

Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Flap (repetitive)

Experimental group

Description:

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)

Treatment:

Device: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)