Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis

University of British Columbia

Status: Completed

Conditions: Mastectomy Flap Necrosis

Treatments: Drug: nitroglycerin ointment; Drug: Polysporin ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT01608880

H12-01161

Details and patient eligibility

About

Background:

Mastectomy flap necrosis (MFN) is a common complication that affects recovery, reconstructive success and aesthetic outcome. Nitroglycerin (NTG) ointment is a potent topical vasodilator that increases local blood flow by dilating arteries and veins without altering the ratio of pre- to post-capillary resistance. There are no studies that evaluate whether the application of NTG ointment in patients undergoing Skin-sparing mastectomy (SSM) or nipple-sparing mastectomy (NSM) and immediate reconstruction decreases the rate of mastectomy flap necrosis.

Objective:

To evaluate if the post-operative application of NTG ointment improve rates of MFN in patients undergoing SSM or NSM with immediate breast reconstruction compared to patients receiving placebo.

Hypothesis:

In patients undergoing SSM and immediate breast reconstruction there will be a decrease in the rate of MFN in those who receive NTG ointment compared to those who receive placebo.

Enrollment: 154 patients

Sex: Female

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who undergo SSM or NSM with immediate alloplastic or autologous breast reconstruction
• Unilateral and bilateral cases (in bilateral cases only the mastectomy performed by the general surgeon will be included. This will avoid the potential effect of absorption of nitroglycerin from one breast to the other)
• Patients older than 21 and less than 65

Exclusion criteria

• Patient declining inclusion in the study

• Patient with medical history that precludes the administration of nitroglycerin, i.e. a medical history significant for

  • Acute circulatory failure accompanied by clear hypotension
  • Myocardial insufficiency related to obstruction
  • Use of sildenafil, vardenafil & tadalafil
  • Use of beta-blockers, calcium channel blockers, diuretics or phenothiazides
  • Salicylates (ASA)
  • Alteplase
  • Recent history of MI or cardiac insufficiency
  • Anemia, severe
  • Cerebral hemorrhage or recent head trauma
  • Glaucoma
  • Hepatic function impairment, severe
  • Hyperthyroidism
  • Hypertrophic cardiomyopathy
  • Hypotension
  • Sensitivity to nitrites

• Patient with a history of mantle radiation

• Patient with an allergy to polysporin or any of its ingredients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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154 participants in 2 patient groups, including a placebo group

Polysporin Control

Placebo Comparator group

Description:

Patients in control group will receive polysporin ointment application. Polysporin ointment will be made to look like Nitroglycerin ointment.

Treatment:

Drug: Polysporin ointment

Nitroglycerin

Active Comparator group

Description:

Patients in treatment group will receive nitroglycerin ointment application

Treatment:

Drug: nitroglycerin ointment