Cutaneous Microcirculation After Plasma Therapy
- Conditions
- Acute WoundBurn ScarBurn InjuryChronic Wound
- Registration Number
- NCT02417818
- Lead Sponsor
- University Hospital Schleswig-Holstein
- Brief Summary
In plastic and reconstructive surgery, treatment strategies of second-degree burns, superficial wounds, burn scars, flaps and chronic wounds aim at reducing infection and improving microcirculation. Although previous studies indicate that Plasma Therapy 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 Plasma Therapy on second-degree burns, superficial wounds, burn scars, flaps and chronic wounds in a human in-vivo setting for the first time.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
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 wound.
Group J (n=20): Consent-capable male and female patients ≥18 years of age suffering from a hypertrophic burn wound.
Group K (n=20): Consent-capable male and female patients ≥18 years of age received a flap.
Group L (n=20): Consent-capable male and female patients ≥18 years of age received a flap.
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
University of Schleswig-Holstein🇩🇪Lübeck, Schleswig-Holstein, Germany