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.

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Key information

Conditions

Mastectomy Flap Necrosis

Age range

21 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Saint Joseph Hospital, Vancouver, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitroglycerin Ointment

Drug

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)

Polysporin ointment

Drug

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.

Primary outcomes

Mastectomy Flap Necrosis

Time frame: 1 month post operative

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: May 31, 2012
Registry last updated: Sep 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.