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CompletedNCT02201979Updated Nov 20, 2014

Laser Fluorescent Imaging of Nipple and Areola During Breast Lift

An observational study in Breast Sagging, Ptosis and Loss of Breast Volume, sponsored by Swanson Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-20.

Sponsored by Swanson Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
15
Ages
18 Years to 80 Years
Sex
Female
01

Study 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. 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.

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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.

02

Conditions studied

  • Breast Sagging
  • Ptosis
  • Loss of Breast Volume

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Keywords

  • breast
  • ptosis
  • sagging
  • implant
  • lift
03

In context

Prolapse

676 studies on the registry are indexed under Prolapse; 79 are open to participants now.

This study's enrollment of 15 is below the median of 126 across 222 observational studies indexed under Prolapse.

Browse Prolapse studies →

Lead sponsor

Swanson Center is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adult women undergoing cosmetic breast lifts in combination with implants.

Inclusion criteria

  • Women aged 18 - 80
  • Consent for participation

Exclusion criteria

Exclusion Criteria:

  • history of allergy to iodinated contrast dye -
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
15 participants (actual)
Patient registry
No

Groups and cohorts

  • Breast lift in combination with implants.

    Patients undergoing breast lifts in combination with implants are studied using laser fluorescent imaging to evaluate blood supply.

    Procedure: Vertical breast lift with implants

Interventions

  • ProcedureVertical breast lift with implants
06

What researchers measure

Primary outcomes

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

    Laser fluorescent imaging is used to evaluate breast blood supply.

    Time frame: 5 months

07

Study locations

1 site
  • Swanson Center
    Leawood, Kansas 66211, United States
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02201979
Lead sponsor
Swanson Center
Responsible party
Eric Swanson, M.D. (Principal Investigator, Swanson Center) — Principal investigator
First posted
Jul 28, 2014
Start date
Jul 2014
Primary completion
Nov 2014
Completion
Nov 2014
Last update
Nov 20, 2014

Study contacts

Eric Swanson, M.D.
principal investigator · Swanson Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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