NCT02273076

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

5 years

First QC Date

October 21, 2014

Last Update Submit

October 28, 2022

Conditions

Disorders of Skin Grafts and Flaps

Outcome Measures

Primary Outcomes (1)

  • skin flap healing

    up to 6 months

Interventions

Spatial Frequency Domain ImagingDEVICE

Spatial Frequency Domain Imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Minor and pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCIMC

Orange, California, 92697, United States

Location

Study Officials

  • Gregory Evans, MD

    UCIMC

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gregory Evans, M.D., Chair, Department of Plastic Surgery

Study Record Dates

First Submitted

October 21, 2014

First Posted

October 23, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

US(1)