Ptosis Clinical Trial
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.
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.
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Observational Model: Case-Only, Time Perspective: Prospective
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