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Predicting Breast Flap Necrosis by Spatial Frequency Domain Imaging

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ClinicalTrials.gov Identifier: NCT02273076
Recruitment Status : Withdrawn
First Posted : October 23, 2014
Last Update Posted : August 30, 2017
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine

Brief Summary:

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 or disease Intervention/treatment
Disorders of Skin Grafts and Flaps Device: 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.


Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Predicting Breast Flap Necrosis by Spatial Frequency Domain Imaging
Study Start Date : October 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Spatial Frequency Domain Imaging
    Spatial Frequency Domain Imaging


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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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 Posted: October 23, 2014    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Necrosis
Skin Diseases
Pathologic Processes