- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02273076
Predicting Breast Flap Necrosis by Spatial Frequency Domain Imaging
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Contacts and Locations
Study Locations
-
-
California
-
Orange, California, United States, 92697
- UCIMC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult male and female 18 years and older scheduled for breast reconstructive surgery.
Exclusion Criteria:
- Minor and pregnant women
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
skin flap healing
Time Frame: up to 6 months
|
up to 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gregory Evans, MD, UCIMC
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20141229
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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