Cutaneous Microcirculation After Extracorporeal Shock Wave Therapy

NCT ID: NCT02417779

Last Updated: 2023-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2023-02-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Second-Degree Burn

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)

Group Type: EXPERIMENTAL

Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Intervention Type: DEVICE

Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Skin Excision (for Skin Graft)

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)

Group Type: EXPERIMENTAL

Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Intervention Type: DEVICE

Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Chronic Wound

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)

Group Type: EXPERIMENTAL

Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Intervention Type: DEVICE

Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Intact Skin

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)

Group Type: ACTIVE_COMPARATOR

Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Intervention Type: DEVICE

Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Second-Degree Burn (repetitive)

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)

Group Type: EXPERIMENTAL

Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Intervention Type: DEVICE

Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Skin Excision (for Skin Graft) (repetitive)

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)

Group Type: EXPERIMENTAL

Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Intervention Type: DEVICE

Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Chronic Wound (repetitive)

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)

Group Type: EXPERIMENTAL

Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Intervention Type: DEVICE

Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Intact Skin (repetitive)

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)

Group Type: ACTIVE_COMPARATOR

Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Intervention Type: DEVICE

Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Hypertrophic burn scar

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)

Group Type: EXPERIMENTAL

Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Intervention Type: DEVICE

Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Hypertrophic burn scar (repetitive)

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)

Group Type: EXPERIMENTAL

Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Intervention Type: DEVICE

Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Flap

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)

Group Type: EXPERIMENTAL

Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Intervention Type: DEVICE

Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Flap (repetitive)

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)

Group Type: EXPERIMENTAL

Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Intervention Type: DEVICE

Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Interventions

Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Intervention Type: DEVICE

Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Intervention Type: DEVICE

Eligibility Criteria

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

• below 18 years of age
• wounds requiring artificial respiration, since consent for the study participation is unobtainable

• peripheral arterial occlusive disease
• vasculitis
• diabetes mellitus
• chronic kidney or liver disease
• cardiac dysfunction
• arterial hypo- or hypertension

• ongoing immunosuppressive or chemotherapy treatment
• drug abuse
• systemic skin diseases
• systemic and local cortisone therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

Tobias Kisch

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tobias Kisch, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Schleswig-Holstein

Locations

University of Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

Countries

Germany

Other Identifiers

14-266-1

Identifier Type: -

Identifier Source: org_study_id