Clinical trial NCT02417818: Cutaneous Microcirculation After Plasma Therapy
Official title: Effects of Plasma Therapy in Cutaneous Microcirculation of Different Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn Injury
Acute Wound
Chronic Wound
Burn Scar
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2015-04-16
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in microcirculation (composite measure)
timeFrame: Baseline and 1 minute post-dose
Secondary outcomes:
measure: Change in microcirculation (areolar measure)
timeFrame: Baseline, while and 1 minute post-dose
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: University of Schleswig-Holstein
state: Schleswig-Holstein
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Tobias Kisch, MD
role: PRINCIPAL_INVESTIGATOR
References: