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Monitoring of Tissue Transfer Flaps by Modulated Imaging

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. Identifier: NCT00792792
Recruitment Status : Withdrawn (Not a clinical trial study.)
First Posted : November 18, 2008
Last Update Posted : December 12, 2017
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine

Brief Summary:
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.

Condition or disease Intervention/treatment
Other Reconstructive Surgery Device: Modulated Imaging

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-contact, Intra-operative & Post-operative Device, Evaluation of Tissue Transfer Flaps After Reconstructive Surgery.
Study Start Date : January 2007
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Tissue transfer skin flap
Modulated Imaging Spectroscopy
Device: Modulated Imaging
Modulated Imaging Spectroscopy

Primary Outcome Measures :
  1. Transfer Skin flap [ Time Frame: up to 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.

Inclusion Criteria:

  • Adult 18 years and older planned to undergo reconstructive surgery

Exclusion Criteria:

  • All emergency reconstructive surgery

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 identifier (NCT number): NCT00792792

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United States, California
University of California Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
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Principal Investigator: Evans R Gregory, PhD Aesthetic & Plastic Surgery Institute, UCIMC

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Responsible Party: Beckman Laser Institute and Medical Center, Gregory Evans, M.D., Chair, Department of Plastic Surgery, University of California, Irvine Identifier: NCT00792792    
Other Study ID Numbers: NIH/LAMMP-2007-5891
First Posted: November 18, 2008    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Keywords provided by Beckman Laser Institute and Medical Center, University of California, Irvine:
tissue transfer