Ischemic Preconditioning Clinical Trial
— RIPCOfficial title:
Effects of Remote Ischemic Preconditioning in Cutaneous Microcirculation of Anterolateral Thigh Flaps
Verified date | November 2010 |
Source | Hannover Medical School |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
Background: In plastic and reconstructive surgery, free flaps are routinely used for
treatment of soft tissue defects. Treatment strategies aim at reducing or preventing flap
necrosis by conditioning tissue tolerance against ischemia. Although previous studies
indicate that remote ischemic preconditioning (RIPC) is a systemic phenomenon, only a few
studies have 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
a potential free flap location in a human in-vivo setting for the first time.
Conclusion: Remote ischemic preconditioning improves cutaneous tissue oxygen saturation,
arterial capillary blood flow and postcapillary venous flow in a remote free flap donor
location. To what extent remote preconditioning might ameliorate the reperfusion injury of
free flap transplantation, further clinical trials have to evaluate both in the means of
microcirculatory assessment and partial or total flap loss as end points of these studies.
Status | Completed |
Enrollment | 27 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - healthy male and female subjects aged 18 to 35 years Exclusion Criteria: - soft tissue inflammation or osteomyelitis, peripheral arterial occlusive disease, vasculitis, chronic kidney or liver disease, cardiac dysfunction, arterial hypotension and any type of vasoactive medication, i.e. ß-blockers, calcium channel blockers, nitroglycerin |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Germany | Medical School Hannover | Hannover |
Lead Sponsor | Collaborator |
---|---|
Hannover Medical School |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in microcirculation | capillary blood flow [arbitrary units AU] capillary blood velocity [AU] tissue oxygen saturation [%] relative postcapillary venous filling pressure [AU] |
No |
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