Laser Fluorescent Imaging of Abdominal Skin During Abdominoplasty
1 other identifier
observational
20
1 country
1
Brief Summary
Abdominoplasty is a common cosmetic operation. Some investigators believe that the risk of complications is reduced by limiting the operative dissection. However, this can compromise the quality of the result. This study was undertaken to investigate the blood supply of the abdominoplasty skin flap during surgery using laser fluorescent imaging. An imaging agent is injected and the fluorescence is recorded using a near-infrared laser. The blood supply is tested after a limited dissection and then after a traditional dissection to determine whether an extended dissection reduces the skin circulation. The study hypothesis is that there is no difference in blood supply and the traditional abdominoplasty does not compromise skin circulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 19, 2014
CompletedFirst Posted
Study publicly available on registry
July 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedNovember 20, 2014
November 1, 2014
4 months
July 19, 2014
November 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Skin circulation during abdominoplasty.
The blood supply to the skin is evaluated intraoperatively using laser fluorescent imaging.
6 months
Study Arms (1)
Patients undergoing abdominoplasty
Skin circulation to abdominal flap is evaluated during surgery using laser fluorescent imaging.
Eligibility Criteria
Adult men and women undergoing abdominoplasty.
You may qualify if:
- Patients undergoing abdominoplasty
You may not qualify if:
- Allergy to iodinated contrast agents
- Nonconsenting patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Swanson Centerlead
Study Sites (1)
Swanson Center
Leawood, Kansas, 66211, United States
Related Publications (2)
Roostaeian J, Harris R, Farkas JP, Barton FE, Kenkel JM. Comparison of Limited-Undermining Lipoabdominoplasty and Traditional Abdominoplasty Using Laser Fluorescence Imaging. Aesthet Surg J. 2014 Jul;34(5):741-7. doi: 10.1177/1090820X14532286. Epub 2014 Jul 1.
PMID: 24809360BACKGROUNDSwanson E. Comparison of Limited and Full Dissection Abdominoplasty Using Laser Fluorescence Imaging to Evaluate Perfusion of the Abdominal Skin. Plast Reconstr Surg. 2015 Jul;136(1):31e-43e. doi: 10.1097/PRS.0000000000001376.
PMID: 26111330DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Swanson, M.D.
Swanson Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 19, 2014
First Posted
July 22, 2014
Study Start
July 1, 2014
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
November 20, 2014
Record last verified: 2014-11