Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis

This study is currently recruiting participants.
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

May 28, 2012
February 28, 2014
August 2012
September 2014   (final data collection date for primary outcome measure)
Mastectomy Flap Necrosis [ Time Frame: 1 month post operative ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01608880 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis
Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Mastectomy Flap Necrosis
  • 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)
  • 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.
  • Placebo Comparator: Polysporin Control
    Patients in control group will receive polysporin ointment application. Polysporin ointment will be made to look like Nitroglycerin ointment.
    Intervention: Drug: Polysporin ointment
  • Active Comparator: Nitroglycerin
    Patients in treatment group will receive nitroglycerin ointment application
    Intervention: Drug: nitroglycerin ointment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
December 2014
September 2014   (final data collection date for primary outcome measure)

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
Female
21 Years to 65 Years
No
Contact: Sheina Macadam, MD, MsC, FRCSC 604-876-1688 drsmacadam@gmail.com
Contact: Perry Gdalevitch, MD, FRCSC 778-829-3442 drperryg@gmail.com
Canada
 
NCT01608880
H12-01161
Yes
University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Sheina Macadam, MD, MSc, FRCSC University of British Columbia
Principal Investigator: Perry Gdalevitch, MD, FRCSC University of British Columbia
University of British Columbia
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP