Effects of Plasma Therapy in Cutaneous Microcirculation of Different Wounds
| Registry | NCT02417818 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 240 (Actual) |
| Sponsor | University Hospital Schleswig-Holstein (Other) |
| Conditions | Burn Injury, Acute Wound, Chronic Wound, Burn Scar |
| Interventions | Plasma Therapy (PlasmaDerm), Repetitive Plasma Therapy (repetitive PlasmaDerm) (Device) |
| Dates | start 2015-03-01, primary completion 2023-02-01, completion 2023-02-01, first posted 2015-04-16, last updated 2023-02-24 |
| Locations | 1 site in Germany |
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All trials for Burn Injury All trials for Acute Wound All trials of Plasma Therapy (PlasmaDerm) All trials of Repetitive Plasma Therapy (repetitive PlasmaDerm)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Second-Degree Burn | Experimental | Device: Plasma Therapy (PlasmaDerm) | 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: Plasma Therapy (PlasmaDerm) |
| Skin Excision (for Skin Graft) | Experimental | Device: Plasma Therapy (PlasmaDerm) | 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. Intervention: Plasma Therapy (PlasmaDerm) |
| Chronic Wound | Experimental | Device: Plasma Therapy (PlasmaDerm) | 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: Plasma Therapy (PlasmaDerm) |
| Intact Skin | Active comparator | Device: Plasma Therapy (PlasmaDerm) | 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: Plasma Therapy (PlasmaDerm) |
| Second-Degree Burn (repetitive) | Experimental | Device: Repetitive Plasma Therapy (repetitive PlasmaDerm) | 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 Plasma Therapy (repetitive PlasmaDerm) |
| Skin Excision (for Skin Graft) (repetitive) | Experimental | Device: Repetitive Plasma Therapy (repetitive PlasmaDerm) | 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. Intervention: Repetitive Plasma Therapy (repetitive PlasmaDerm) |
| Chronic Wound (repetitive) | Experimental | Device: Repetitive Plasma Therapy (repetitive PlasmaDerm) | 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 Plasma Therapy (repetitive PlasmaDerm) |
| Intact Skin (repetitive) | Active comparator | Device: Repetitive Plasma Therapy (repetitive PlasmaDerm) | 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 Plasma Therapy (repetitive PlasmaDerm) |
| Hypertrophic burn scar | Experimental | Device: Plasma Therapy (PlasmaDerm) | Group F (n=20): Consent-capable male and female patients ≥18 years of age who suffer from a hypertrophic burn scar. Intervention: Repetitive Plasma Therapy (repetitive PlasmaDerm) |
| Hypertrophic burn scar (repetitive) | Experimental | Device: Repetitive Plasma Therapy (repetitive PlasmaDerm) | Group F (n=20): Consent-capable male and female patients ≥18 years of age who suffer from a hypertrophic burn scar. Intervention: Repetitive Plasma Therapy (repetitive PlasmaDerm) |
| Flap | Experimental | Device: Plasma Therapy (PlasmaDerm) | Group F (n=20): Consent-capable male and female patients ≥18 years of age who received a flap. Intervention: Repetitive Plasma Therapy (repetitive PlasmaDerm) |
| Flap (repetitive) | Experimental | Device: Repetitive Plasma Therapy (repetitive PlasmaDerm) | Group F (n=20): Consent-capable male and female patients ≥18 years of age who received a flap. Intervention: Repetitive Plasma Therapy (repetitive PlasmaDerm) |
Sex: All, ages: 18 Years to any
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 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. 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
| Facility | City | Country | Status |
|---|---|---|---|
| University of Schleswig-Holstein | Lübeck, Schleswig-Holstein | Germany |