Predicting Breast Flap Necrosis by Spatial Frequency Domain Imaging

NCT ID: NCT02273076

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WITHDRAWN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

2014-10-31

Study Completion Date

2019-10-31

Brief Summary

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The current surgical procedure for breast diseases places an emphasis on the conservation of breast skin in order to provide more optimal reconstruction.

The purpose of this study is to use portable, non-contact optical imaging device developed at the Beckman Laser Institute called Spatial Frequency Domain Imaging to detect the changes in a skin during reconstructive surgery procedure and healing process.

Detailed Description

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The researchers can use Spatial Frequency Domain Imaging instrument to measure the concentration of blood flow in the skin tissue and can determine of the changes that observed in the properties of the mastectomy flap that may be delay in healing process.

The imaging device can determine the change from baseline measurement to the development of skin necrosis, wound infection, or implant extrusion.

Conditions

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Disorders of Skin Grafts and Flaps

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Spatial Frequency Domain Imaging

Spatial Frequency Domain Imaging

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult male and female 18 years and older scheduled for breast reconstructive surgery.

Exclusion Criteria

* Minor and pregnant women
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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Gregory Evans, MD

Role: PRINCIPAL_INVESTIGATOR

UCIMC

Locations

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UCIMC

Orange, California, United States

Site Status

Countries

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United States

Other Identifiers

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20141229

Identifier Type: -

Identifier Source: org_study_id

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