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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02273076
Other study ID # 20141229
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date October 2014
Est. completion date October 2019

Study information

Verified date October 2022
Source University of California, Irvine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2019
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult male and female 18 years and older scheduled for breast reconstructive surgery. Exclusion Criteria: - Minor and pregnant women

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Spatial Frequency Domain Imaging
Spatial Frequency Domain Imaging

Locations

Country Name City State
United States UCIMC Orange California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Irvine Beckman Laser Institute University of California Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary skin flap healing up to 6 months