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Free Flap Microcirculatory Monitoring Correlates to Free Flap Temperature Assessment

This study has been completed.
Sponsor:
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01235299
First received: November 4, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235299

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

No publications provided by Hannover Medical School

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hannover Medical School, Plastic, Hand and Reconstructive Surgery
ClinicalTrials.gov Identifier: NCT01235299     History of Changes
Other Study ID Numbers: Kraemer002
Study First Received: November 4, 2010
Last Updated: November 4, 2010
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on June 18, 2013