- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02417805
Cutaneous Microcirculation After Remote Ischemic Preconditioning
Effects of Remote Ischemic Preconditioning in Cutaneous Microcirculation of Different Wounds
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Schleswig-Holstein
-
Lübeck, Schleswig-Holstein, Germany, 23538
- University of Schleswig-Holstein
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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: Remote Ischemic Preconditioning (by Blood Pressure Cuff) |
Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.
|
Experimental: 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: Remote Ischemic Preconditioning (by Blood Pressure Cuff) |
Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.
|
Experimental: 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: Remote Ischemic Preconditioning (by Blood Pressure Cuff) |
Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.
|
Active Comparator: 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: Remote Ischemic Preconditioning (by Blood Pressure Cuff) |
Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in microcirculation (composite measure)
Time Frame: Baseline and 1 minute post-dose
|
|
Baseline and 1 minute post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in microcirculation (areolar measure)
Time Frame: Baseline, while and 1 minute post-dose
|
|
Baseline, while and 1 minute post-dose
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-266-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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