We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01608880
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : September 10, 2014
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:


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.


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.


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.

Condition or disease Intervention/treatment Phase
Mastectomy Flap Necrosis Drug: nitroglycerin ointment Drug: Polysporin ointment Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis
Study Start Date : August 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
Placebo Comparator: Polysporin Control
Patients in control group will receive polysporin ointment application. Polysporin ointment will be made to look like Nitroglycerin ointment.
Drug: Polysporin ointment
Polysporin ointment will be applied as the control ointment on the mastectomy flap skin at the end of surgery. A maximum of 7.5cm strip of ointment will be applied to the skin.

Active Comparator: Nitroglycerin
Patients in treatment group will receive nitroglycerin ointment application
Drug: nitroglycerin ointment
Nitroglycerin ointment will be applied to mastectomy skin flaps at the end of surgery. A maximum of 7.5cm strip of 2% Nitroglycerin ointment will be applied (equivalent to a maximal dose of 45mg)

Primary Outcome Measures :
  1. Mastectomy Flap Necrosis [ Time Frame: 1 month post operative ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608880

Layout table for location information
Canada, British Columbia
Mount Saint Joseph Hospital
Vancouver, British Columbia, Canada, V5T 3N4
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
University of British Columbia Hospital
Vancouver, British Columbia, Canada, V6T 2B5
Sponsors and Collaborators
University of British Columbia
Layout table for investigator information
Principal Investigator: Sheina Macadam, MD, MSc, FRCSC University of British Columbia
Principal Investigator: Perry Gdalevitch, MD, FRCSC University of British Columbia
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01608880    
Other Study ID Numbers: H12-01161
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: September 10, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Pathologic Processes
Vasodilator Agents