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Breast SaggingNCT02201979

Laser Fluorescent Imaging of Nipple and Areola During Breast Lift

An observational study of Breast Sagging and Ptosis, 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

Breast lift surgery performed in combination with breast implants is a common cosmetic operation. However, there have been concerns regarding the safety of this treatment combination. Read more about this study

Who is it for?
Ages 18 to 80 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Sagging, Ptosis, Loss of Breast Volume
What is being tested?
Vertical breast lift with implants
Type of treatment
Surgery or procedure
How many people
15 participants
Where
1 siteUnited States
Study dates
Jul 2014to Nov 2014
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
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adult women undergoing cosmetic breast lifts in combination with implants.

Who may be able to join

  • Women aged 18 - 80
  • Consent for participation

Who cannot join

  • history of allergy to iodinated contrast dye -

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

Official title: Laser Fluorescent Imaging of Nipple and Areola During Breast Lift in Combination With Breast Implants

Breast lift surgery performed in combination with breast implants is a common cosmetic operation. However, there have been concerns regarding the safety of this treatment combination. Some investigators are concerned that an implant may increase the risk of complications, including loss of circulation to the nipple and areola. This study was undertaken to evaluate the blood supply of the breast using intraoperative laser fluorescent imaging and to determine whether a breast implant compromises blood supply to the nipple and areola.

Read the detailed description

Protocol

Laser Fluorescent Imaging of Breasts During Vertical Breast Lifts and Reductions Performed in Combination with Breast Implants.

Background/Purpose

Today, breast lifts are a common operation. Implants may be recommended to provide greater fullness of the upper poles of the breasts. One of the risks of surgery is compromised circulation to the nipples and areolae. Some investigators believe that the simultaneous insertion of breast implants adds to the risk by causing pressure on the overlying breast tissue and skin.1 Staging the procedure (first the breast lift and then implants or vice versa) has been recommended, but staging is inconvenient and costly for patients, necessitating two operations. Clinical experience with the newer vertical breast lift technique, as opposed to the traditional inferior pedicle technique, has been favorable, with few reported complications.2 The vertical technique uses a shorter, more superficial pedicle than the traditional inferior pedicle, with a more reliable blood supply.2 A breast lift and reduction are essentially the same operation; more breast tissue is removed during a reduction but the dissection is the same.

This study was undertaken to investigate the blood supply to the nipples and areolae during the combined breast lift/reduction and implants procedure. Laser fluorescent imaging represents an objective measurement technique that has been used for several years to monitor the vascularity of flaps used in breast reconstruction.

Subjects

Fifteen consecutive consenting adult women undergoing outpatient elective breast lifts or reductions in combination with breast implants will be investigated. By testing the blood supply at two time points, the patient serves as 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 800-810 nm. The imaging agent is injected intravenously. Starting within 5-10 seconds of injection, the system records images of the breasts, showing the fluorescence, which indicates blood supply. The half-life of the imaging agent is 2.5-3 minutes.

Surgery

The implants are inserted and the breast lift/reduction procedure is performed on both sides using the vertical technique.2 The implants are not inflated. The filling tubes are left in place. At this point, 3 mL (7.5 mg) of indocyanine green is injected and the image is recorded, documenting blood supply to both breasts. Next, the implants are inflated using the filling tubes. After inflation of the implants, the breasts are reimaged, with the filling tubes still in place. Once adequate circulation is demonstrated, the filling tubes are removed. In the unlikely event that inadequate circulation is found during imaging, the implant volume may be reduced accordingly, and a third image taken to confirm adequate circulation to the nipples.

Null Hypothesis

A breast lift or reduction performed using the vertical technique in combination with insertion of breast implants does not compromise circulation to the nipples and areolae and may be safely performed simultaneously, avoiding a need for staged surgery.

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 implant volume, or forego their simultaneous insertion if necessary and reduce the risk of tissue loss and delayed wound healing, known complications of breast lifts and reductions.

Sample Size

A sample of 15 patients is anticipated, treated over a period of approximately 5 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.

Being tested
Vertical breast lift with implants
Keywords
breast, ptosis, sagging, implant, lift
Medical subject headings
Blepharoptosis

What participants receive

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

  • Vertical breast lift with implantsProcedure or surgery

Study groups in NCT02201979
Study groupRoleWhat they receive
Breast lift in combination with implants.Patients undergoing breast lifts in combination with implants are studied using laser fluorescent imaging to evaluate blood supply.
Receives: Procedure: Vertical breast lift with implants

What is being measured

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

  1. Blood supply to breast as evaluated by laser fluorescent imaging

    Laser fluorescent imaging is used to evaluate breast blood supply.

    Measured: 5 months

Timeline

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

  1. First posted28 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
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02201979
Sponsor's protocol ID
Swanson 004
Status last verified
Nov 2014
First submitted
24 Jul 2014
Last updated
20 Nov 2014
Results posted
No
Data monitoring committee
No

Publications

  • Swanson E. Prospective comparative clinical evaluation of 784 consecutive cases of breast augmentation and vertical mammaplasty, performed individually and in combination. Plast Reconstr Surg. 2013 Jul;132(1):30e-45e. doi: 10.1097/PRS.0b013e3182910b2e.

    PubMed 23806952

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Sagging and Ptosis, 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 2 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: 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?

Blood supply to breast as evaluated by laser fluorescent imaging (time frame: 5 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 NCT02201979, which also lists 1 linked publication.

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; AzTrials last refreshed its copy on 8 Nov 2026.

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