Cutaneous Microcirculation After Remote Ischemic Preconditioning

Not Applicable

Completed

• Conditions: Chronic Wound; Burn Injury; Acute Wound

• Registration Number: NCT02417805
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-04-11
• Study First Posted: 2015-04-16
• Status Verified: 2023-02
• Primary Completion: 2023-02
• Study Completion: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in microcirculation (composite measure)	Baseline and 1 minute post-dose	* capillary blood flow \[arbitrary units AU\]; * capillary blood velocity \[AU\]; * tissue oxygen saturation \[%\]; * relative postcapillary venous filling pressure \[AU\]

Secondary Outcome Measures

Name	Time	Method
Change in microcirculation (areolar measure)	Baseline, while and 1 minute post-dose	* tissue oxygen saturation \[%\]; * tissue hemoglobin index

Trial Locations

Locations (1)

University of Schleswig-Holstein; 🇩🇪 Lübeck, Schleswig-Holstein, Germany