Cutaneous Microcirculation After Extracorporeal Shock Wave Therapy

Not Applicable

Completed

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

• Registration Number: NCT02417779
• Lead Sponsor: University Hospital Schleswig-Holstein

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-04-11
• Study First Posted: 2015-04-16
• Status Verified: 2023-02
• Primary Completion: 2023-02
• Study Completion: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in microcirculation (composite measure)	Baseline and 1 minute post-dose	* capillary blood flow \[arbitrary units AU\]; * capillary blood velocity \[AU\]; * tissue oxygen saturation \[%\]; * relative postcapillary venous filling pressure \[AU\]

Secondary Outcome Measures

Name	Time	Method
Change in microcirculation (areolar measure)	Baseline, while and 1 minute post-dose	* tissue oxygen saturation \[%\]; * tissue hemoglobin index

Trial Locations

Locations (1)

University of Schleswig-Holstein; 🇩🇪 Lübeck, Schleswig-Holstein, Germany