Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis
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|ClinicalTrials.gov Identifier: NCT01608880|
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : September 10, 2014
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.
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.
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 or disease||Intervention/treatment||Phase|
|Mastectomy Flap Necrosis||Drug: nitroglycerin ointment Drug: Polysporin ointment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||June 2014|
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)
- Mastectomy Flap Necrosis [ Time Frame: 1 month post operative ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608880
|Canada, British Columbia|
|Mount Saint Joseph Hospital|
|Vancouver, British Columbia, Canada, V5T 3N4|
|Vancouver General Hospital|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|University of British Columbia Hospital|
|Vancouver, British Columbia, Canada, V6T 2B5|
|Principal Investigator:||Sheina Macadam, MD, MSc, FRCSC||University of British Columbia|
|Principal Investigator:||Perry Gdalevitch, MD, FRCSC||University of British Columbia|