Cutaneous Microcirculation After Plasma Therapy

Burn Injury Clinical Trial

Official title:

Effects of Plasma Therapy in Cutaneous Microcirculation of Different Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417818
• Other study ID #: 14-266-3
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: February 2023

Study information

• Verified date: February 2023
• Source: University Hospital Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Wound
• Burn Injury
• Burn Scar
• Chronic Wound
• Wounds and Injuries

Intervention

Device:
• Plasma Therapy (PlasmaDerm)
Plasma Therapy (PlasmaDerm)
• Repetitive Plasma Therapy (repetitive PlasmaDerm)
Repetitive Plasma Therapy (Repetitive PlasmaDerm)

Locations

Country	Name	City	State
Germany	University of Schleswig-Holstein	Lübeck	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

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