Monitoring of Tissue Transfer Flaps by Modulated Imaging

NCT ID: NCT00792792

Last Updated: 2022-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Other Reconstructive Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Tissue transfer skin flap

Modulated Imaging Spectroscopy

Modulated Imaging

Intervention Type DEVICE

Modulated Imaging Spectroscopy

Interventions

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Modulated Imaging

Modulated Imaging Spectroscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult 18 years and older planned to undergo reconstructive surgery

Exclusion Criteria

* All emergency reconstructive surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Beckman Laser Institute and Medical Center

Gregory Evans, M.D., Chair, Department of Plastic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evans R Gregory, PhD

Role: PRINCIPAL_INVESTIGATOR

Aesthetic & Plastic Surgery Institute, UCIMC

Locations

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University of California Medical Center

Orange, California, United States

Site Status

Countries

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United States

Other Identifiers

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20075891

Identifier Type: -

Identifier Source: org_study_id

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