Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01608880
First received: May 28, 2012
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Mastectomy Flap Necrosis
Drug: nitroglycerin ointment
Drug: Polysporin ointment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Mastectomy Flap Necrosis [ Time Frame: 1 month post operative ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608880

Contacts
Contact: Sheina Macadam, MD, MsC, FRCSC 604-876-1688 drsmacadam@gmail.com
Contact: Perry Gdalevitch, MD, FRCSC 778-829-3442 drperryg@gmail.com

Locations
Canada, British Columbia
University of British Columbia Hospital Recruiting
Vancouver, British Columbia, Canada, V6T 2B5
Contact: Sheina Macadam, MD, MSc, FRCSC    604-876-1688    drsmacadam@gmail.com   
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Sheina Macadam, MD,MSc, FRCSC    604-876-1688    drsmacadam@gmail.com   
Mount Saint Joseph Hospital Recruiting
Vancouver, British Columbia, Canada, V5T 3N4
Contact: Sheina Macadam, MD, MSc, FRCSC    604-876-1688    drsmacadam@gmail.com   
Sponsors and Collaborators
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
  More Information

Publications:

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01608880     History of Changes
Other Study ID Numbers: H12-01161
Study First Received: May 28, 2012
Last Updated: February 28, 2014
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Additional relevant MeSH terms:
Necrosis
Pathologic Processes
Nitroglycerin
Bacitracin
Gramicidin
Polymyxin B
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 08, 2014