Cutaneous Microcirculation After Extracorporeal Shock Wave Therapy

Burn Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417779
• Other study ID #: 14-266-1
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: February 2023

Study information

• Verified date: February 2023
• Source: University Hospital Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Wound
• Burn Injury
• Burn Scar
• Chronic Wound
• Flap Disorder
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Germany	University of Schleswig-Holstein	Lübeck	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in microcirculation (areolar measure)	tissue oxygen saturation [%]; tissue hemoglobin index	Baseline, while and 1 minute post-dose