Predicting Breast Flap Necrosis by Spatial Frequency Domain Imaging

October 28, 2022 updated by: Beckman Laser Institute and Medical Center, University of California, Irvine

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

Withdrawn

Conditions

Disorders of Skin Grafts and Flaps

Intervention / Treatment

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Orange, California, United States, 92697
    - UCIMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

Minor and pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

Beckman Laser Institute University of California Irvine

Investigators

Principal Investigator: Gregory Evans, MD, UCIMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

October 21, 2014

First Submitted That Met QC Criteria