Microcirculation Clinical Trial
Official title:
Impact of Active Thermoregulation on the Microcirculation of Free Flaps
This study evaluates the impact of active thermoregulation on free flap microcirculation following free flap transfer. Thermoregulation is performed by passive warming, active warming (water circulation based device) and active cooling. Changes in microcirculation are assessed using combined laser Doppler flowmetry and remission spectroscopy.
Status | Completed |
Enrollment | 25 |
Est. completion date | April 2015 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: Patients receiving free perforator flaps with a skin island not less than 4x4 cm Exclusion Criteria: - non-compliance, - non-consent, - history of cardiac disease, - arterial hypo- or hypertension, - intake of vasoactive drugs, - peripheral arterial occlusive disease, - chronic kidney and liver disease, - vasculitis |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Germany | Department of Plastic, Reconstructive, Hand and Burn Surgery, Bogenhausen Academic Hospital, Munich 81925, Germany | Munich | Bavaria |
Lead Sponsor | Collaborator |
---|---|
Ulf Dornseifer, MD |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood Flow (AU) measured by Doppler flowmetry and remission spectroscopy (Oxygen to See, O2C®, Lea Medizintechnik, Giessen, Germany) | Measurements were conducted at the day of the operation | No |
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