Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis

September 8, 2014 updated by: University of British Columbia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
      • Vancouver, British Columbia, Canada, V6T 2B5
        • University of British Columbia Hospital
      • Vancouver, British Columbia, Canada, V5T 3N4
        • Mount Saint Joseph Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mastectomy Flap Necrosis
Time Frame: 1 month post operative
1 month post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Sheina Macadam, MD, MSc, FRCSC, University of British Columbia
  • Principal Investigator: Perry Gdalevitch, MD, FRCSC, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

May 28, 2012

First Submitted That Met QC Criteria

May 30, 2012

First Posted (Estimate)

May 31, 2012

Study Record Updates

Last Update Posted (Estimate)

September 10, 2014

Last Update Submitted That Met QC Criteria

September 8, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H12-01161

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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