Abdominal Skin Redundancy Clinical Trial
Official title:
Laser Fluorescent Imaging of Abdominal Skin During Abdominoplasty
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.
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.
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Observational Model: Case-Only, Time Perspective: Prospective