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Predicting Breast Flap Necrosis by Spatial Frequency Domain Imaging

Predicting Breast Flap Necrosis by Spatial Frequency Domain Imaging

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02273076
Enrollment
0
Registered
2014-10-23
Start date
2014-10-31
Completion date
2019-10-31
Last updated
2022-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorders of Skin Grafts and Flaps

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.

Interventions

Spatial Frequency Domain Imaging

Sponsors

Beckman Laser Institute University of California Irvine
CollaboratorOTHER
University of California, Irvine
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Minor and pregnant women

Design outcomes

Primary

MeasureTime frame
skin flap healingup to 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026