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Predicting Breast Flap Necrosis by Spatial Frequency Domain Imaging

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02273076
First Posted: October 23, 2014
Last Update Posted: August 30, 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. 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

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.


Condition Intervention
Disorders of Skin Grafts and Flaps Device: Spatial Frequency Domain Imaging

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Predicting Breast Flap Necrosis by Spatial Frequency Domain Imaging

Resource links provided by NLM:


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

Primary Outcome Measures:
  • skin flap healing [ Time Frame: up to 6 months ]

Enrollment: 0
Study Start Date: October 2014
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Spatial Frequency Domain Imaging
    Spatial Frequency Domain Imaging
Detailed Description:

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.

  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 recruited from UCI Anesthetic and Plastic Surgery Institute clinics, seen by the Plastic Surgery Service. Subjects requiring breast reconstructive surgery using either implant based or autologous reconstruction will be identified.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Minor and pregnant women
  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): NCT02273076


Locations
United States, California
UCIMC
Orange, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Gregory Evans, MD 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: NCT02273076     History of Changes
Other Study ID Numbers: NIH-LAMMP-2014-1229
First Submitted: October 21, 2014
First Posted: October 23, 2014
Last Update Posted: August 30, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Necrosis
Skin Diseases
Pathologic Processes