Predicting Breast Flap Necrosis by Spatial Frequency Domain Imaging

Withdrawn

• Conditions: Disorders of Skin Grafts and Flaps

• Registration Number: NCT02273076
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-10-21
• Study First Posted: 2014-10-23
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• Minor and pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
skin flap healing	up to 6 months

Trial Locations

Locations (1)

UCIMC; 🇺🇸 Orange, California, United States