Disorders of Skin Grafts and FlapsNCT02273076
Predicting Breast Flap Necrosis by Spatial Frequency Domain Imaging
An observational study of Disorders of Skin Grafts and Flaps, run by University of California, Irvine at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorders of Skin Grafts and Flaps
- What is being tested?
- Spatial Frequency Domain Imaging
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult male and female 18 years and older scheduled for breast reconstructive surgery.
Who cannot join
- Minor and pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Disorders of Skin Grafts and Flaps
- Being tested
- Spatial Frequency Domain Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatial Frequency Domain ImagingDevice
Spatial Frequency Domain Imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
skin flap healing
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of Skin Grafts and FlapsStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Gregory Evans, MD, Principal investigator, UCIMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273076
- Sponsor's protocol ID
- 20141229
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2014
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Breast Flap Necrosis by Spatial Frequency Domain Imaging
- ClinicalTrials.gov ID
- NCT02273076
- Acronym / sponsor ID
- 20141229
- Conditions
- Disorders of Skin Grafts and Flaps
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Oct 2014
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 23 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult male and female 18 years and older scheduled for breast reconstructive surgery.
Key exclusion criteria (1 listed)
- Minor and pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spatial Frequency Domain ImagingSpatial Frequency Domain Imaging | Device | – |
Primary outcome
skin flap healing
Time frame: up to 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Evans, MD principal investigator
UCIMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorders of Skin Grafts and Flaps, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin flap healing (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.