Cutaneous Microcirculation After Plasma Therapy

University Hospital Schleswig-Holstein (UKSH)

Status: Completed

Conditions: Acute Wound; Chronic Wound; Burn Scar; Burn Injury

Treatments: Device: Plasma Therapy (PlasmaDerm); Device: Repetitive Plasma Therapy (repetitive PlasmaDerm)

Study type: Interventional

Funder types: Other

Identifiers

NCT02417818

14-266-3

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 12 patient groups

Second-Degree Burn

Experimental group

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: Plasma Therapy (PlasmaDerm)

Treatment:

Device: Plasma Therapy (PlasmaDerm)

Skin Excision (for Skin Graft)

Experimental group

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 of the skin-graft donor site must not be less than 1% of TBSA. Intervention: Plasma Therapy (PlasmaDerm)

Treatment:

Device: Plasma Therapy (PlasmaDerm)

Chronic Wound

Experimental group

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: Plasma Therapy (PlasmaDerm)

Treatment:

Device: Plasma Therapy (PlasmaDerm)

Intact Skin

Active Comparator group

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: Plasma Therapy (PlasmaDerm)

Treatment:

Device: Plasma Therapy (PlasmaDerm)

Second-Degree Burn (repetitive)

Experimental group

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 Plasma Therapy (repetitive PlasmaDerm)

Treatment:

Device: Repetitive Plasma Therapy (repetitive PlasmaDerm)

Skin Excision (for Skin Graft) (repetitive)

Experimental group

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 of the skin-graft donor site must not be less than 1% of TBSA. Intervention: Repetitive Plasma Therapy (repetitive PlasmaDerm)

Treatment:

Device: Repetitive Plasma Therapy (repetitive PlasmaDerm)

Chronic Wound (repetitive)

Experimental group

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 Plasma Therapy (repetitive PlasmaDerm)

Treatment:

Device: Repetitive Plasma Therapy (repetitive PlasmaDerm)

Intact Skin (repetitive)

Active Comparator group

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 Plasma Therapy (repetitive PlasmaDerm)

Treatment:

Device: Repetitive Plasma Therapy (repetitive PlasmaDerm)

Hypertrophic burn scar

Experimental group

Description:

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)

Treatment:

Device: Plasma Therapy (PlasmaDerm)

Hypertrophic burn scar (repetitive)

Experimental group

Description:

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)

Treatment:

Device: Repetitive Plasma Therapy (repetitive PlasmaDerm)

Flap

Experimental group

Description:

Group F (n=20): Consent-capable male and female patients ≥18 years of age who received a flap. Intervention: Repetitive Plasma Therapy (repetitive PlasmaDerm)

Treatment:

Device: Plasma Therapy (PlasmaDerm)

Flap (repetitive)

Experimental group

Description:

Group F (n=20): Consent-capable male and female patients ≥18 years of age who received a flap. Intervention: Repetitive Plasma Therapy (repetitive PlasmaDerm)

Treatment:

Device: Repetitive Plasma Therapy (repetitive PlasmaDerm)