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Monitoring of Tissue Transfer Flaps by Modulated Imaging

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00792792
First received: November 14, 2008
Last updated: October 22, 2014
Last verified: October 2014

November 14, 2008
October 22, 2014
January 2007
June 2018   (final data collection date for primary outcome measure)
Transfer Skin flap [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
a correlation between the immediate post-operative optical properties of tissue transfer flaps and the development of late complications. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
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
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.
 
Enrolling by invitation
200
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00792792
NIH/LAMMP WIFI-RR-01192-29
No
Montana Compton, University of California, Irvine
Montana Compton
Beckman Laser Institute University of California Irvine
Principal Investigator: Evans R Gregory, PhD Aesthetic & Plastic Surgery Institute, UCIMC
University of California, Irvine
October 2014

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