Cutaneous Microcirculation After Remote Ischemic Preconditioning

University Hospital Schleswig-Holstein (UKSH)

Status: Completed

Conditions: Acute Wound; Chronic Wound; Burn Injury

Treatments: Procedure: Intervention: Remote Ischemic Preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT02417805

14-266-2

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• below 18 years of age
• wounds requiring artificial respiration, since consent for the study participation is unobtainable

Exclusion Criteria Groups A, B, D:

• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 4 patient groups

Second-Degree Burn

Experimental group

Description:

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)

Treatment:

Procedure: Intervention: Remote Ischemic Preconditioning

Skin Excision (for Skin Graft)

Experimental group

Description:

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)

Treatment:

Procedure: Intervention: Remote Ischemic Preconditioning

Chronic Wound

Experimental group

Description:

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)

Treatment:

Procedure: Intervention: Remote Ischemic Preconditioning

Intact Skin

Active Comparator group

Description:

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)

Treatment:

Procedure: Intervention: Remote Ischemic Preconditioning