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Cutaneous Microcirculation After Extracorporeal Shock Wave Therapy

Primary Purpose

Burn Injury, Acute Wound, Chronic Wound

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Sponsored by
University Hospital Schleswig-Holstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Burn Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Schleswig-Holstein

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Experimental

Experimental

Experimental

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Second-Degree Burn

Skin Excision (for Skin Graft)

Chronic Wound

Intact Skin

Second-Degree Burn (repetitive)

Skin Excision (for Skin Graft) (repetitive)

Chronic Wound (repetitive)

Intact Skin (repetitive)

Hypertrophic burn scar

Hypertrophic burn scar (repetitive)

Flap

Flap (repetitive)

Arm 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)

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 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 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 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 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 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 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 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 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 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 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)

Outcomes

Primary Outcome Measures

Change in microcirculation (composite measure)
capillary blood flow [arbitrary units AU] capillary blood velocity [AU] tissue oxygen saturation [%] relative postcapillary venous filling pressure [AU]

Secondary Outcome Measures

Change in microcirculation (areolar measure)
tissue oxygen saturation [%] tissue hemoglobin index

Full Information

First Posted
March 12, 2015
Last Updated
February 22, 2023
Sponsor
University Hospital Schleswig-Holstein
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1. Study Identification

Unique Protocol Identification Number
NCT02417779
Brief Title
Cutaneous Microcirculation After Extracorporeal Shock Wave Therapy
Official Title
Effects of Extracorporeal Shock Wave Therapy in Cutaneous Microcirculation of Different Wounds
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
February 2023 (Actual)
Study Completion Date
February 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Injury, Acute Wound, Chronic Wound, Burn Scar, Flap Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Second-Degree Burn
Arm Type
Experimental
Arm 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)
Arm Title
Skin Excision (for Skin Graft)
Arm Type
Experimental
Arm 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)
Arm Title
Chronic Wound
Arm Type
Experimental
Arm 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)
Arm Title
Intact Skin
Arm Type
Active Comparator
Arm 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)
Arm Title
Second-Degree Burn (repetitive)
Arm Type
Experimental
Arm 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)
Arm Title
Skin Excision (for Skin Graft) (repetitive)
Arm Type
Experimental
Arm 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)
Arm Title
Chronic Wound (repetitive)
Arm Type
Experimental
Arm 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)
Arm Title
Intact Skin (repetitive)
Arm Type
Active Comparator
Arm 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)
Arm Title
Hypertrophic burn scar
Arm Type
Experimental
Arm 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)
Arm Title
Hypertrophic burn scar (repetitive)
Arm Type
Experimental
Arm 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)
Arm Title
Flap
Arm Type
Experimental
Arm 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)
Arm Title
Flap (repetitive)
Arm Type
Experimental
Arm 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)
Intervention Type
Device
Intervention Name(s)
Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Intervention Description
Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Intervention Type
Device
Intervention Name(s)
Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Intervention Description
Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Primary Outcome Measure Information:
Title
Change in microcirculation (composite measure)
Description
capillary blood flow [arbitrary units AU] capillary blood velocity [AU] tissue oxygen saturation [%] relative postcapillary venous filling pressure [AU]
Time Frame
Baseline and 1 minute post-dose
Secondary Outcome Measure Information:
Title
Change in microcirculation (areolar measure)
Description
tissue oxygen saturation [%] tissue hemoglobin index
Time Frame
Baseline, while and 1 minute post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Kisch, MD
Organizational Affiliation
University Hospital Schleswig-Holstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Schleswig-Holstein
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany

12. IPD Sharing Statement

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Cutaneous Microcirculation After Extracorporeal Shock Wave Therapy

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