NCT02196779

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

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

4 months

First QC Date

July 19, 2014

Last Update Submit

November 18, 2014

Conditions

Keywords

Abdominoplastycirculationskindissectionlaserfluorescenceimaging

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

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

Swanson Center

Leawood, Kansas, 66211, United States

Location

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: 24809360BACKGROUND
  • Swanson 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.

Study Officials

  • Eric Swanson, M.D.

    Swanson Center

    PRINCIPAL INVESTIGATOR

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

Locations