Clinical trial NCT01608880: Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis
Official title: Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mastectomy Flap Necrosis
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2012-05-31
Enrollment: 154
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Mastectomy Flap Necrosis
timeFrame: 1 month post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Mount Saint Joseph Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: University of British Columbia Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Sheina Macadam, MD, MSc, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Perry Gdalevitch, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Gdalevitch P, Brasher P, Macadam S. Reply: Effects of Nitroglycerin Ointment on Mastectomy Flap Necrosis in Immediate Breast Reconstruction: A Randomized Controlled Trial. Plast Reconstr Surg. 2016 Apr;137(4):748e. doi: 10.1097/01.prs.0000481832.83256.5d. No abstract available.
citation: Gdalevitch P, Van Laeken N, Bahng S, Ho A, Bovill E, Lennox P, Brasher P, Macadam S. Effects of nitroglycerin ointment on mastectomy flap necrosis in immediate breast reconstruction: a randomized controlled trial. Plast Reconstr Surg. 2015 Jun;135(6):1530-1539. doi: 10.1097/PRS.0000000000001237.