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Free Flap Microcirculatory Monitoring Correlates to Free Flap Temperature Assessment

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ClinicalTrials.gov Identifier: NCT01235299
Recruitment Status : Completed
First Posted : November 5, 2010
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Hannover Medical School

Brief Summary:
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 or disease
Flap Monitoring

Study Type : Observational
Actual Enrollment : 54 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Free Flap Microcirculatory Monitoring Correlates to Free Flap Temperature Assessment
Study Start Date : September 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Group/Cohort
Healthy subjects
Subjects suffering from Diabetes mellitus
Subjects suffering from peripheral arterial occlusive disease



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


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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older 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.

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

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 Posted: November 5, 2010    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: November 2010