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Monitoring of Tissue Transfer Flaps by Modulated Imaging

This study is currently recruiting participants.
Verified February 2017 by Beckman Laser Institute and Medical Center, University of California, Irvine
Sponsor:
ClinicalTrials.gov Identifier:
NCT00792792
First Posted: November 18, 2008
Last Update Posted: February 10, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
  Purpose
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 Intervention
Other Reconstructive Surgery Device: Modulated Imaging

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-contact, Intra-operative & Post-operative Device, Evaluation of Tissue Transfer Flaps After Reconstructive Surgery.

Resource links provided by NLM:


Further study details as provided by Beckman Laser Institute and Medical Center, University of California, Irvine:

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

Estimated Enrollment: 200
Study Start Date: January 2007
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Tissue transfer skin flap
Modulated Imaging Spectroscopy
Device: Modulated Imaging
Modulated Imaging Spectroscopy

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
Criteria

Inclusion Criteria:

  • Adult 18 years and older planned to undergo reconstructive surgery

Exclusion Criteria:

  • All emergency reconstructive surgery
  Contacts and Locations
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): NCT00792792


Contacts
Contact: Ata Sharif, MD 714-456-5755 sharifs@uci.edu
Contact: Christopher Ellstrom, MD 714-456-5755 ellstros@uci.edu

Locations
United States, California
University of California Medical Center Recruiting
Orange, California, United States, 92868
Contact: Ata Sharif, MD    714-456-5755    sharifs@uci.edu   
Contact: Christopher Ellstrom, MD    714.456.5755    ellstros@uci.edu   
Principal Investigator: Gregory R Evans, MD         
Sub-Investigator: Mark R Kobayashi, M.D         
Sub-Investigator: Garrett A Wirth, M.D.         
Sub-Investigator: Anthony J Durkin, Ph.D.         
Sub-Investigator: Thomas Scholz, M.D         
Sub-Investigator: Aaron Kosins, M.D         
Sub-Investigator: Rolf B Saager, PhD         
Sub-Investigator: Keyianoosh Z Paydar, MD         
Sub-Investigator: Ata Sharif, MD         
Sub-Investigator: Adrien Ponticorvo, PhD         
Sub-Investigator: Christopher Ellstrom, MD         
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Evans R Gregory, PhD Aesthetic & Plastic Surgery Institute, UCIMC
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, Gregory Evans, M.D., Chair, Department of Plastic Surgery, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00792792     History of Changes
Other Study ID Numbers: NIH/LAMMP-2007-5891
First Submitted: November 14, 2008
First Posted: November 18, 2008
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Beckman Laser Institute and Medical Center, University of California, Irvine:
tissue transfer