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.
Additional locations may be listed on ClinicalTrials.gov for NCT03716050.
See trial information on ClinicalTrials.gov for a list of participating sites.
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.
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorIvo Pestana