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In plastic and reconstructive surgery, treatment strategies of second-degree burns, superficial wounds and chronic wounds aim at reducing infection and improving microcirculation. Although previous studies indicate that remote ischemic preconditioning (RIPC) 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 remote ischemic preconditioning on second-degree burns, superficial and chronic wounds in a human in-vivo setting for the first time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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: Remote Ischemic Preconditioning (by Blood Pressure Cuff) |
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| 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: Remote Ischemic Preconditioning (by Blood Pressure Cuff) |
|
| 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: Remote Ischemic Preconditioning (by Blood Pressure Cuff) |
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| 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: Remote Ischemic Preconditioning (by Blood Pressure Cuff) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention: Remote Ischemic Preconditioning | Procedure | Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in microcirculation (composite measure) |
| Baseline and 1 minute post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change in microcirculation (areolar measure) |
| Baseline, while and 1 minute post-dose |
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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.
Exclusion Criteria:
General exclusion criteria
Exclusion Criteria Groups A, B, D:
Anamnestic exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Kisch, MD | University Hospital Schleswig-Holstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Schleswig-Holstein | Lübeck | Schleswig-Holstein | 23538 | Germany |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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