Cutaneous Microcirculation After Plasma Therapy

February 22, 2023 updated by: Tobias Kisch, University Hospital Schleswig-Holstein

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in microcirculation (composite measure)
Time Frame: Baseline and 1 minute post-dose
  • 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in microcirculation (areolar measure)
Time Frame: Baseline, while and 1 minute post-dose
  • tissue oxygen saturation [%]
  • tissue hemoglobin index
Baseline, while and 1 minute post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Schleswig-Holstein

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-266-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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