Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis
Information source: University of British Columbia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mastectomy Flap Necrosis
Intervention: nitroglycerin ointment (Drug); Polysporin ointment (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s):
Sheina Macadam, MD, MSc, FRCSC, Principal Investigator, Affiliation: University of British Columbia
Perry Gdalevitch, MD, FRCSC, Principal Investigator, Affiliation: University of British Columbia
Summary
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.
Clinical Details
Official title: Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Mastectomy Flap Necrosis
Eligibility
Minimum age: 21 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Mount Saint Joseph Hospital, Vancouver, British Columbia V5T 3N4, Canada
University of British Columbia Hospital, Vancouver, British Columbia V6T 2B5, Canada
Vancouver General Hospital, Vancouver, British Columbia V5Z 1M9, Canada
Additional Information
Starting date: August 2012
Last updated: September 8, 2014
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