NCT02417818CompletedNot Applicable

Effects of Plasma Therapy in Cutaneous Microcirculation of Different Wounds

University Hospital Schleswig-Holstein1 site in 1 country240 target enrollmentStarted: March 1, 2015Last updated: February 24, 2023

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor
Enrollment: 240
Locations: 1
Primary Endpoint: Change in microcirculation (composite measure)

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Single (Participant)

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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

Arms & Interventions

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)

Intervention: Plasma Therapy (PlasmaDerm) (Device)

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)

Intervention: Plasma Therapy (PlasmaDerm) (Device)

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)

Intervention: Plasma Therapy (PlasmaDerm) (Device)

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)

Intervention: Plasma Therapy (PlasmaDerm) (Device)

Second-Degree Burn (repetitive)

Experimental

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.