The Effect of Nitroglycerin Ointment, Fluorescent Angiography, and Incisional Negative Pressure Wound Therapy on Mastectomy Skin Flap Perfusion-Related Problems

This study's aim is to evaluate and compare a variety of interventions and their effect on
the incidence of perfusion related problems in patients with breast cancer undergoing
mastectomy and implant-based immediate breast reconstruction (IBR). The ability to identify,
prevent and treat these perfusion related problems can help maximize aesthetic results after
breast surgery, improve patient satisfaction with both mastectomy and breast reconstruction,
and reduce healthcare cost associated with mastectomy and reconstruction complications.The
study team will perform a randomized pilot study comprised of eight groups. All of these
groups employ accepted techniques, medications and dressings and therefore are not
experimental.

Group 1: Breast skin after mastectomy will be clinically examined by the surgeon to determine
if there is adequate blood flow to the skin to allow safe coverage of the breast implant. No
dye study, ointment, or vacuum dressing will be applied to the breast after implant
placement.

Group 2 - Breast skin after mastectomy will be clinically examined by the surgeon, and
nitroglycerin (NTG) cream will be applied to the breast skin after implant placement. This
cream does not have systemic effects but may improve blood flow to the remnant breast skin
after mastectomy.

Group 3 - Breast skin after mastectomy will be clinically examined by the surgeon, and an
incisional vacuum-assisted dressing (iVAC) will be placed over the breast incisions after
implant placement, which may improve blood flow to the skin and help wound healing.

Group 4 - Breast skin after mastectomy will be clinically examined by the surgeon, and both
NTG cream will be applied to the breast skin and an iVAC will be placed over the incisions
after implant placement.

Group 5 - Blood flow to breast skin after mastectomy will be examined using a fluorescent dye
study called fluorescent angiography (FA) to determine if there is adequate blood flow to the
skin to allow safe coverage of the breast implant. No further intervention will be used after
implant placement.

Group 6 - Blood flow to breast skin breast skin will be examined using FA, and NTG cream will
be applied to the skin after the implant is placed.

Group 7 - Blood flow to breast skin breast skin will be examined using FA, and an iVAC will
be placed over breast skin incisions after the implant is placed.

Group 8 - Blood flow to breast skin breast skin will be examined using FA, and both NTG cream
and iVAC will be used as interventions after the implant is placed.

The dosage of indocyanine-green (IC-green) to be used for assessment of mastectomy flaps will
be in 10 mg boluses, not to exceed 5 mg/kg.

Nitro-Bid® (nitroglycerin ointment, 2%) at a dose of 45 mg (equal to 7.5 cm on the measuring
strip provided with packaging) will be used. The paste will be applied to remnant breast skin
after skin closure and surgical dressings placed over top.

Incisional negative pressure wound therapy will consist of a standard sponge dressing with
adhesive drape, either Ioban® 2 (3M ™) or KCI-V.A.C.® Drape (KCI®), to continuous suction at
125 mm Hg while the patient is in hospital and not to exceed 4 days.

A physician will see the subjects on a regular weekly basis for up to 30 days once the
procedure has been completed. These clinical visits are standard of care and the subject's
health and well-being will be monitored rigorously during these visits. If during any of
these visits, the physician deems a therapy necessary to prevent impairment/damage and
improve well-being, the subject will be treated appropriately.

Inclusion Criteria:

- Patients must be female.

- Patients must be between the ages of 18 and 99 years.

- Patients must undergo mastectomy with our attending breast oncology surgeons followed
by possible implant-based immediate breast reconstruction (IBR) performed by our
attending plastic surgeons at WFBMC.

- Patients must have the ability to understand and the willingness to sign an
IRB-approved informed consent document.

Exclusion Criteria:

- Patients who are under the age of 18 or over the age of 99.

- Patients who are undergoing mastectomy without immediate breast reconstruction
including immediate breast reconstruction with autologous tissue (or combination of
autologous tissue with tissue expanders or implants), or patients with a history of
mastectomy presenting for delayed breast reconstruction.

- Patients with pre-existing conditions in which use of indocyanine-green is
contraindicated or must be used with caution, including those with a history of
allergy to iodides or iodinated dye, those with chronic kidney disease, those with
hepatic failure or cirrhosis of the liver, and females who are nursing, pregnant, or
may become pregnant.

- Pregnant women are excluded from this study because pregnancy precludes immediate
breast reconstruction in our patient population.

- Patients with pre-existing conditions in which use of nitroglycerin paste is
contraindicated, including those with a history of cardiac insufficiency, hypotension,
sensitivity to nitrites, severe liver impairment, glaucoma, hyperthyroidism, recent
head trauma, severe anemia, or taking certain medication (i.e. alteplase, aspirin,
beta-blocker, calcium channel blocker, diuretics or thiazides).

- Patients with pre-existing conditions in whom use of incisional negative pressure
wound therapy is contraindicated including those with evidence of surgical site
infection ( i.e. erythema, purulent drainage), clinical signs of hematoma (i.e. wound
swelling, fluctuance, blood drainage), history of persistent cancer, exposed blood
vessel on site of proposed therapeutic use, or sensitivity to acrylics and adhesives.