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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Second-Degree Burn | Experimental | 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 | 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 | 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 | 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma Therapy (PlasmaDerm) | Device | Plasma Therapy (PlasmaDerm) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in microcirculation (composite measure) |
| Baseline and 1 minute post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change in microcirculation (areolar measure) |
| Baseline, while and 1 minute post-dose |
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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
Exclusion criteria groups A, B, D, E, F, H:
Anamnestic exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Kisch, MD | University Hospital Schleswig-Holstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Schleswig-Holstein | Lübeck | Schleswig-Holstein | 23538 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36326797 | Derived | Lucius J, Jensen JO, Tasar RR, Schleusser S, Stang FH, Mailander P, Kisch T. Acute Microcirculatory Effects of Remote Ischemic Conditioning in Superficial Partial Thickness Burn Wounds. J Burn Care Res. 2023 Jul 5;44(4):912-917. doi: 10.1093/jbcr/irac166. |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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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 | 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 | 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 | 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 | 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 | 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 | Group F (n=20): Consent-capable male and female patients ≥18 years of age who received a flap. Intervention: Repetitive Plasma Therapy (repetitive PlasmaDerm) |
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| Flap (repetitive) | Experimental | Group F (n=20): Consent-capable male and female patients ≥18 years of age who received a flap. Intervention: Repetitive Plasma Therapy (repetitive PlasmaDerm) |
|
| Repetitive Plasma Therapy (repetitive PlasmaDerm) | Device | Repetitive Plasma Therapy (Repetitive PlasmaDerm) |
|