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Free Flap Microcirculatory Monitoring Correlates to Free Flap Temperature Assessment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01235299
First received: November 4, 2010
Last updated: February 23, 2017
Last verified: November 2010
November 4, 2010
February 23, 2017
September 2010
November 2010   (Final data collection date for primary outcome measure)
Correlation of cutaneous microcirculation to free flap temperature [ Time Frame: 4 months ]
Same as current
Complete list of historical versions of study NCT01235299 on ClinicalTrials.gov Archive Site
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Free Flap Microcirculatory Monitoring Correlates to Free Flap Temperature Assessment
Free Flap Microcirculatory Monitoring Correlates to Free Flap Temperature Assessment
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
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.
Flap Monitoring
Not Provided
  • Healthy subjects
  • Subjects suffering from Diabetes mellitus
  • Subjects suffering from peripheral arterial occlusive disease
Kraemer R, Lorenzen J, Knobloch K, Papst S, Kabbani M, Koennecker S, Vogt PM. Free flap microcirculatory monitoring correlates to free flap temperature assessment. J Plast Reconstr Aesthet Surg. 2011 Oct;64(10):1353-8. doi: 10.1016/j.bjps.2011.04.030. Epub 2011 Jun 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
November 2010
November 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
16 Years to 65 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01235299
Kraemer002
No
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Hannover Medical School
Hannover Medical School
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Hannover Medical School
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP