Mastectomy Flap Necrosis Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 154 |
| Est. completion date | June 2014 |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 21 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Mount Saint Joseph Hospital | Vancouver | British Columbia |
| Canada | University of British Columbia Hospital | Vancouver | British Columbia |
| Canada | Vancouver General Hospital | Vancouver | British Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| University of British Columbia |
Canada,
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* Note: There are 17 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mastectomy Flap Necrosis | 1 month post operative | No |