Cutaneous Microcirculation After Plasma Therapy

Effects of Plasma Therapy in Cutaneous Microcirculation of Different Wounds

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 Overview

• Status: Completed
• Conditions: Burn Scar; Chronic Wound; Burn Injury; Acute Wound
• Intervention / Treatment: Device: Plasma Therapy (PlasmaDerm); Device: Repetitive Plasma Therapy (repetitive PlasmaDerm)

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • University of Schleswig-Holstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Second-Degree Burn; 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)	Device: Plasma Therapy (PlasmaDerm); Plasma Therapy (PlasmaDerm)
Experimental: Skin Excision (for Skin Graft); 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)	Device: Plasma Therapy (PlasmaDerm); Plasma Therapy (PlasmaDerm)
Experimental: Chronic Wound; 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)	Device: Plasma Therapy (PlasmaDerm); Plasma Therapy (PlasmaDerm)
Active Comparator: Intact Skin; 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)	Device: Plasma Therapy (PlasmaDerm); Plasma Therapy (PlasmaDerm)
Experimental: Second-Degree Burn (repetitive); 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)	Device: Repetitive Plasma Therapy (repetitive PlasmaDerm); Repetitive Plasma Therapy (Repetitive PlasmaDerm)
Experimental: Skin Excision (for Skin Graft) (repetitive); 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)	Device: Repetitive Plasma Therapy (repetitive PlasmaDerm); Repetitive Plasma Therapy (Repetitive PlasmaDerm)
Experimental: Chronic Wound (repetitive); 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)	Device: Repetitive Plasma Therapy (repetitive PlasmaDerm); Repetitive Plasma Therapy (Repetitive PlasmaDerm)
Active Comparator: Intact Skin (repetitive); 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)	Device: Repetitive Plasma Therapy (repetitive PlasmaDerm); Repetitive Plasma Therapy (Repetitive PlasmaDerm)
Experimental: Hypertrophic burn scar; 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)	Device: Plasma Therapy (PlasmaDerm); Plasma Therapy (PlasmaDerm)
Experimental: Hypertrophic burn scar (repetitive); 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)	Device: Repetitive Plasma Therapy (repetitive PlasmaDerm); Repetitive Plasma Therapy (Repetitive PlasmaDerm)
Experimental: Flap; Group F (n=20): Consent-capable male and female patients ≥18 years of age who received a flap. Intervention: Repetitive Plasma Therapy (repetitive PlasmaDerm)	Device: Plasma Therapy (PlasmaDerm); Plasma Therapy (PlasmaDerm)
Experimental: Flap (repetitive); Group F (n=20): Consent-capable male and female patients ≥18 years of age who received a flap. Intervention: Repetitive Plasma Therapy (repetitive PlasmaDerm)	Device: Repetitive Plasma Therapy (repetitive PlasmaDerm); Repetitive Plasma Therapy (Repetitive PlasmaDerm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in microcirculation (composite measure)	capillary blood flow [arbitrary units AU]; capillary blood velocity [AU]; tissue oxygen saturation [%]; relative postcapillary venous filling pressure [AU]	Baseline and 1 minute post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in microcirculation (areolar measure)	tissue oxygen saturation [%]; tissue hemoglobin index	Baseline, while and 1 minute post-dose

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: March 12, 2015
• First Submitted That Met QC Criteria: April 11, 2015
• First Posted (Estimate): April 16, 2015

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 14-266-3