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Monitoring of Tissue Transfer Flaps by Modulated Imaging

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ClinicalTrials.gov Identifier: NCT00792792
Recruitment Status : Withdrawn (Not a clinical trial study.)
First Posted : November 18, 2008
Last Update Posted : December 12, 2017
Information provided by (Responsible Party):

November 14, 2008
November 18, 2008
December 12, 2017
January 2007
June 2018   (Final data collection date for primary outcome measure)
Transfer Skin flap [ Time Frame: up to 6 weeks ]
a correlation between the immediate post-operative optical properties of tissue transfer flaps and the development of late complications. [ Time Frame: 1 week ]
Complete list of historical versions of study NCT00792792 on ClinicalTrials.gov Archive Site
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Monitoring of Tissue Transfer Flaps by Modulated Imaging
Non-contact, Intra-operative & Post-operative Device, Evaluation of Tissue Transfer Flaps After Reconstructive Surgery.
Tissue transfer flaps are a method of moving tissue from a donor location to a recipient location. In the case of a free tissue transfer flaps, the blood vessels to the transferred tissues are detached and then re-attached to different arteries and veins at the recipient site. The process of reconstructive surgery using tissue transfer flaps is not without complications. These complications may include acute arterial or venous occlusion, as well as the development of late complications such as fat necrosis and flap atrophy.
The researchers developed a safe, non-contact, intra-operative and post-operative device called Modulated Imaging, can detect changes in a flap's optical properties and can correlate with arterial or venous occlusion or with the development of fat necrosis or flap atrophy.
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample
Study population will be selected from Surgical Department as outpatients and in-patient bases that require reconstructive surgery using a pedicle or free tissue transfer flap.
Other Reconstructive Surgery
Device: Modulated Imaging
Modulated Imaging Spectroscopy
Tissue transfer skin flap
Modulated Imaging Spectroscopy
Intervention: Device: Modulated Imaging
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2018
June 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult 18 years and older planned to undergo reconstructive surgery

Exclusion Criteria:

  • All emergency reconstructive surgery
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Beckman Laser Institute and Medical Center, University of California, Irvine
University of California, Irvine
Beckman Laser Institute University of California Irvine
Principal Investigator: Evans R Gregory, PhD Aesthetic & Plastic Surgery Institute, UCIMC
University of California, Irvine
December 2017