Nitroglycerin Ointment, Fluorescent Angiography, and Incisional Negative-Pressure Wound Therapy in Preventing Skin Flap Problems in Patients Undergoing Mastectomy

Status: Active

Description

This phase II / III trial studies how well nitroglycerin ointment, fluorescent angiography, and incisional negative-pressure wound therapy work in preventing skin flap problems in patients undergoing mastectomy. Nitroglycerin ointment may help prevent problems when used after immediate breast reconstruction. Fluorescent angiography uses dye and a specialized camera to inspect blood flow. Negative-pressure wound therapy uses a vacuum dressing to promote healing. These different ways of examining blood flow to the skin remaining after mastectomy are accepted techniques that may improve the outcome of mastectomy and breast reconstruction surgery.

Eligibility Criteria

Inclusion Criteria

  • 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 Wake Forest Baptist Medical Center (WFBMC).
  • Patients must have the ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document.

Exclusion Criteria

  • 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 allergy to acrylics and adhesives.

Locations & Contacts

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: Active
Contact: Ivo Pestana
Phone: 336-716-4171
Email: ipestana@wakehealth.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To evaluate and to compare the described interventions and their effect on the incidence of perfusion-related problems (PRPs) in patients with breast cancer undergoing mastectomy and implant-based immediate breast reconstruction (IBR).

OUTLINE: Patients are randomized to 1 of 8 groups.

GROUP I: Patients undergo breast skin examination after mastectomy.

GROUP II: Patients undergo breast skin examination after mastectomy and application of Nitro-Bid nitroglycerin (NTG) cream to the breast skin after implant placement.

GROUP III: Patients undergo breast skin examination after mastectomy and placement of an incisional vacuum-assisted dressing (iVAC) over the breast incisions after implant placement.

GROUP IV: Patients undergo breast skin examination after mastectomy, application of Nitro-Bid NTG cream to breast skin, and placement of iVAC over the incisions after implant placement.

GROUP V: Patients undergo examination of blood flow to breast skin after mastectomy using fluorescent angiography (FA).

GROUP VI: Patients undergo examination of blood flow to breast skin after mastectomy using FA and application of Nitro-Bid NTG cream to the skin after implant placement.

GROUP VII: Patients undergo examination of blood flow to breast skin after mastectomy using FA and placement of iVAC over breast skin incisions after implant placement.

GROUP VIII: Patients undergo examination of blood flow to breast skin after mastectomy using FA, application of Nitro-Bid NTG cream to the breast skin, and placement of iVAC over the breast incisions after implant placement.

After completion of study, patients are followed weekly for 30 days.

Trial Phase & Type

Trial Phase

Phase II/III

Trial Type

Prevention

Lead Organization

Lead Organization
Wake Forest University Health Sciences

Principal Investigator
Ivo Pestana

Trial IDs

Primary ID CCCWFU 03216
Secondary IDs NCI-2018-02734
Clinicaltrials.gov ID NCT03716050