Cutaneous Microcirculation After Plasma Therapy

NCT02417818 | Completed

• 1 other identifier: 14-266-3
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn Injury; Acute Wound; Chronic Wound; Burn Scar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in microcirculation (areolar measure)

  Baseline, while and 1 minute post-dose

Study Arms (12)

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)

Device: Plasma Therapy (PlasmaDerm)

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)

Device: Plasma Therapy (PlasmaDerm)

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)

Device: Plasma Therapy (PlasmaDerm)

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)

Device: Plasma Therapy (PlasmaDerm)

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. Intervention: Repetitive Plasma Therapy (repetitive PlasmaDerm)

Device: Repetitive Plasma Therapy (repetitive PlasmaDerm)

Skin Excision (for Skin Graft) (repetitive)

EXPERIMENTAL

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)

Chronic Wound (repetitive)

EXPERIMENTAL

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)

Intact Skin (repetitive)

ACTIVE COMPARATOR

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)

Hypertrophic burn scar

EXPERIMENTAL

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)

Hypertrophic burn scar (repetitive)

EXPERIMENTAL

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)

Flap

EXPERIMENTAL

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)

Flap (repetitive)

EXPERIMENTAL

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)

Interventions

Plasma Therapy (PlasmaDerm) DEVICE

Plasma Therapy (PlasmaDerm)

Chronic Wound; Flap; Hypertrophic burn scar; Intact Skin; Second-Degree Burn; Skin Excision (for Skin Graft)

Repetitive Plasma Therapy (repetitive PlasmaDerm) DEVICE

Repetitive Plasma Therapy (Repetitive PlasmaDerm)

Chronic Wound (repetitive); Flap (repetitive); Hypertrophic burn scar (repetitive); Intact Skin (repetitive); Second-Degree Burn (repetitive); Skin Excision (for Skin Graft) (repetitive)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• below 18 years of age
• wounds requiring artificial respiration, since consent for the study participation is unobtainable
• peripheral arterial occlusive disease
• vasculitis
• diabetes mellitus
• chronic kidney or liver disease
• cardiac dysfunction
• arterial hypo- or hypertension
• ongoing immunosuppressive or chemotherapy treatment
• drug abuse
• systemic skin diseases
• systemic and local cortisone therapy

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

University of Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Related Publications (1)

• Lucius J, Jensen JO, Tasar RR, Schleusser S, Stang FH, Mailander P, Kisch T. Acute Microcirculatory Effects of Remote Ischemic Conditioning in Superficial Partial Thickness Burn Wounds. J Burn Care Res. 2023 Jul 5;44(4):912-917. doi: 10.1093/jbcr/irac166.

  PMID: 36326797 DERIVED

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Tobias Kisch, MD

  University Hospital Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: April 16, 2015
• Study Start: March 1, 2015
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

DE (1)