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Free Flap Microcirculatory Monitoring Correlates to Free Flap Temperature Assessment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01235299
First Posted: November 5, 2010
Last Update Posted: February 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hannover Medical School
  Purpose
In case of free flap failure, time is of utmost importance as salvage rates have been reported to be inversely related to the time interval between the onset of ischemia and its clinical recognition. Consecutively, monitoring of free flaps remains of major importance. Currently, combined Laser-Doppler and Spectrophotometry is available to determine microcirculation of free flaps in reconstructive surgery as a scientific method of reliable assessment of flap perfusion. The investigators thought to analyze the correlation of free flap skin temperature and free frap microcirculation as an accurate tool of postoperative flap monitoring.

Condition
Flap Monitoring

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Free Flap Microcirculatory Monitoring Correlates to Free Flap Temperature Assessment

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Correlation of cutaneous microcirculation to free flap temperature [ Time Frame: 4 months ]

Enrollment: 54
Study Start Date: September 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy subjects
Subjects suffering from Diabetes mellitus
Subjects suffering from peripheral arterial occlusive disease

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients suffering from a soft tissue defect at any location of the body receiving free flap soft-tissue defect coverage at the Department of Plastic, Hand and Reconstructive Surgery, Medical School Hannover, Germany.
Criteria

Inclusion Criteria:

  • Age between 16 and 65 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 or equal.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01235299


Locations
Germany
Medical School Hannover
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT01235299     History of Changes
Other Study ID Numbers: Kraemer002
First Submitted: November 4, 2010
First Posted: November 5, 2010
Last Update Posted: February 27, 2017
Last Verified: November 2010