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Abdominal Skin RedundancyNCT02196779

Laser Fluorescent Imaging of Abdominal Skin During Abdominoplasty

An observational study of Abdominal Skin Redundancy, run by Swanson Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Abdominal Skin Redundancy
How many people
20 participants
Where
1 siteUnited States
Study dates
Jul 2014to Nov 2014
How long will I take part?
6 Months
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 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adult men and women undergoing abdominoplasty.

Who may be able to join

  • Patients undergoing abdominoplasty

Who cannot join

  • Allergy to iodinated contrast agents
  • Nonconsenting patients

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Swanson Center

    Leawood, Kansas, 66211

Other trials in United States

About this study

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.

Read the detailed description

Protocol

Laser Fluorescent Imaging of Abdominal Skin During Abdominoplasty.

Background/Purpose

Abdominoplasty (tummy tuck) is a common cosmetic operation. One of the risks of surgery is delayed wound healing caused by impaired circulation to the skin. In an effort to reduce risk, some investigators1 advocate a limited-undermining technique, with preservation of the perforating blood vessels and preservation of the Scarpa fascia of the lower abdomen. However, there is no evidence that this limited-undermining technique improves blood supply compared with a traditional abdominoplasty dissection. Such a limited dissection may compromise the cosmetic result.

This study was undertaken to investigate the blood supply of the abdominal skin during the abdominoplasty procedure. By testing the circulation at two points during the dissection, and a third time after completion of the operation, data may be obtained and used to evaluate the effect of the extent of the dissection on blood supply of the skin flap.

Laser fluorescent imaging represents an objective measurement technique that has been used to quantitate blood supply in skin flaps and other tissues. It has been used for several years to monitor the vascularity of flaps used in breast reconstruction. This technique has also been used previously in patients undergoing abdominoplasty.2

Subjects

Twenty consecutive consenting adult men and women undergoing outpatient elective abdominoplasty will be investigated using laser fluorescent imaging. By testing the blood supply at three time points, the patient serves as his or her own control.

Imaging

The SPY Elite Intraoperative Perfusion Assessment System (Lifecell Corp., Branchburg, NJ) consists of a near-infrared laser that detects fluorescence. The imaging agent, indocyanine green, is absorbed at this region of the spectrum, 800-810 nm. The imaging agent is injected intravenously. Starting within 5-10 seconds of injection, the system records images of the abdomen, showing the fluorescence, which indicates blood supply. The half-life of the imaging agent is 2.5-3 minutes. The imaging agent is metabolized by the liver. The only known risk is an allergic reaction to the imaging agent. Patients with a history of an allergic reaction to iodinated contrast dyes are excluded.

Surgery

The lipoabdominoplasty technique is performed as described by Saldanha et al.1 Following this limited dissection, 3 mL (7.5 mg) of indocyanine green is injected and the abdominal image is recorded, documenting blood supply to the lower abdomen. After further dissection, another 3 mL of imaging agent is injected and the lower abdomen is re-imaged. On completion of surgery, a third injection is administered and a final image is recorded.

Null Hypothesis

A traditional abdominoplasty dissection does not compromise circulation compared with a more limited dissection technique.

Informed Consent

Patients are informed as to the nature of the study and are told that their participation is entirely voluntary and they are free to decline, and that doing so does not in any way prejudice their treatment. Patients are informed of the small risk of an allergic reaction that will be treated if it occurs.

Patient Risk

There is no patient risk apart from a very small risk of allergic reaction, which is further reduced by excluding any patient with a known allergy to iodinated contrast dye. The study does not affect patient treatment. It offers the possibility of detection of reduced skin circulation, information that can be used by the surgeon to limit the dissection if necessary and avoid tissue loss and delayed wound healing, known complications of abdominoplasty.

Sample Size

A sample of 20 patients is anticipated, treated over a period of approximately 6 months.

Disclosure

The author has no financial interest in any of the products, devices, or drugs mentioned in this article. The author has no conflicts of interest to disclose. There was no outside funding for this study.

Keywords
Abdominoplasty, circulation, skin, dissection, laser, fluorescence, imaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02196779
Study groupRoleWhat they receive
Patients undergoing abdominoplastySkin circulation to abdominal flap is evaluated during surgery using laser fluorescent imaging.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Skin circulation during abdominoplasty.

    The blood supply to the skin is evaluated intraoperatively using laser fluorescent imaging.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

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 only
Time perspective
Prospective
Enrolment
20 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02196779
Sponsor's protocol ID
Swanson 003
Status last verified
Nov 2014
First submitted
19 Jul 2014
Last updated
20 Nov 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24809360
  • 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.

    PubMed 26111330

Questions about this trial

What is this clinical trial studying?

An observational study of Abdominal Skin Redundancy, run by Swanson Center 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 2 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: finished, as of the sponsor's last update on 20 Nov 2014. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 circulation during abdominoplasty. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02196779, which also lists 2 linked publications.

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 20 Nov 2014.

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