Cutaneous Microcirculation After Plasma Therapy

NCT ID: NCT02417818

Last Updated: 2023-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2023-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

Plasma Therapy (PlasmaDerm)

Intervention Type: DEVICE

Plasma Therapy (PlasmaDerm)

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)

Group Type: EXPERIMENTAL

Plasma Therapy (PlasmaDerm)

Intervention Type: DEVICE

Plasma Therapy (PlasmaDerm)

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)

Group Type: EXPERIMENTAL

Plasma Therapy (PlasmaDerm)

Intervention Type: DEVICE

Plasma Therapy (PlasmaDerm)

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)

Group Type: ACTIVE_COMPARATOR

Plasma Therapy (PlasmaDerm)

Intervention Type: DEVICE

Plasma Therapy (PlasmaDerm)

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)

Group Type: EXPERIMENTAL

Repetitive Plasma Therapy (repetitive PlasmaDerm)

Intervention Type: DEVICE

Repetitive Plasma Therapy (Repetitive PlasmaDerm)

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)

Group Type: EXPERIMENTAL

Repetitive Plasma Therapy (repetitive PlasmaDerm)

Intervention Type: DEVICE

Repetitive Plasma Therapy (Repetitive PlasmaDerm)

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)

Group Type: EXPERIMENTAL

Repetitive Plasma Therapy (repetitive PlasmaDerm)

Intervention Type: DEVICE

Repetitive Plasma Therapy (Repetitive PlasmaDerm)

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)

Group Type: ACTIVE_COMPARATOR

Repetitive Plasma Therapy (repetitive PlasmaDerm)

Intervention Type: DEVICE

Repetitive Plasma Therapy (Repetitive PlasmaDerm)

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)

Group Type: EXPERIMENTAL

Plasma Therapy (PlasmaDerm)

Intervention Type: DEVICE

Plasma Therapy (PlasmaDerm)

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)

Group Type: EXPERIMENTAL

Repetitive Plasma Therapy (repetitive PlasmaDerm)

Intervention Type: DEVICE

Repetitive Plasma Therapy (Repetitive PlasmaDerm)

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)

Group Type: EXPERIMENTAL

Plasma Therapy (PlasmaDerm)

Intervention Type: DEVICE

Plasma Therapy (PlasmaDerm)

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)

Group Type: EXPERIMENTAL

Repetitive Plasma Therapy (repetitive PlasmaDerm)

Intervention Type: DEVICE

Repetitive Plasma Therapy (Repetitive PlasmaDerm)

Interventions

Plasma Therapy (PlasmaDerm)

Plasma Therapy (PlasmaDerm)

Intervention Type: DEVICE

Repetitive Plasma Therapy (repetitive PlasmaDerm)

Repetitive Plasma Therapy (Repetitive PlasmaDerm)

Intervention Type: DEVICE

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

Tobias Kisch

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tobias Kisch, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Schleswig-Holstein

Locations

University of Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 36326797 (View on PubMed)

Other Identifiers

14-266-3

Identifier Type: -

Identifier Source: org_study_id