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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polysporin Control | Placebo Comparator | Patients in control group will receive polysporin ointment application. Polysporin ointment will be made to look like Nitroglycerin ointment. |
|
| Nitroglycerin | Active Comparator | Patients in treatment group will receive nitroglycerin ointment application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Mastectomy Flap Necrosis | 1 month post operative |
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Inclusion Criteria:
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
Patient with a history of mantle radiation
Patient with an allergy to polysporin or any of its ingredients
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| Name | Affiliation | Role |
|---|---|---|
| Sheina Macadam, MD, MSc, FRCSC | University of British Columbia | Principal Investigator |
| Perry Gdalevitch, MD, FRCSC | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Saint Joseph Hospital | Vancouver | British Columbia | V5T 3N4 | Canada | ||
| Vancouver General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21542401 | Result | Kutun S, Ay AA, Ulucanlar H, Tarcan O, Ay A, Aldan M, Gorkem G, Demir A, Cetin A. Is transdermal nitroglycerin application effective in preventing and healing flap ischaemia after modified radical mastectomy? S Afr J Surg. 2010 Nov;48(4):119-21. | |
| 8331946 | Result | Fan Z, He J. Preventing necrosis of the skin flaps with nitroglycerin after radical resection for breast cancer. J Surg Oncol. 1993 Jul;53(3):210. doi: 10.1002/jso.2930530319. No abstract available. |
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| ID | Term |
|---|---|
| C420142 | polysporin ointment |
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| 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. |
|
| Vancouver |
| British Columbia |
| V5Z 1M9 |
| Canada |
| University of British Columbia Hospital | Vancouver | British Columbia | V6T 2B5 | Canada |
| 6427801 | Result | Rohrich RJ, Cherry GW, Spira M. Enhancement of skin-flap survival using nitroglycerin ointment. Plast Reconstr Surg. 1984 Jun;73(6):943-8. doi: 10.1097/00006534-198406000-00016. |
| 1447671 | Result | Wong AF, McCulloch LM, Sola A. Treatment of peripheral tissue ischemia with topical nitroglycerin ointment in neonates. J Pediatr. 1992 Dec;121(6):980-3. doi: 10.1016/s0022-3476(05)80356-7. |
| 9215351 | Result | Jones JT, Stenson MA, Spannagel BD, Robinson DD. Treatment of pressure ulcers with nitropaste. J Am Geriatr Soc. 1997 Jul;45(7):895. doi: 10.1111/j.1532-5415.1997.tb01528.x. No abstract available. |
| 17054170 | Result | Nelson R. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD003431. doi: 10.1002/14651858.CD003431.pub2. |
| 16526822 | Result | Fenton C, Wellington K, Easthope SE. 0.4% nitroglycerin ointment : in the treatment of chronic anal fissure pain. Drugs. 2006;66(3):343-9. doi: 10.2165/00003495-200666030-00006. |
| 19939277 | Result | Rao R, Saint-Cyr M, Ma AM, Bowling M, Hatef DA, Andrews V, Xie XJ, Zogakis T, Rohrich R. Prediction of post-operative necrosis after mastectomy: a pilot study utilizing optical diffusion imaging spectroscopy. World J Surg Oncol. 2009 Nov 25;7:91. doi: 10.1186/1477-7819-7-91. |
| 18580145 | Result | Losken A, Styblo TM, Schaefer TG, Carlson GW. The use of fluorescein dye as a predictor of mastectomy skin flap viability following autologous tissue reconstruction. Ann Plast Surg. 2008 Jul;61(1):24-9. doi: 10.1097/SAP.0b013e318156621d. |
| 20409522 | Result | Chun YS, Verma K, Rosen H, Lipsitz SR, Breuing K, Guo L, Golshan M, Grigorian N, Eriksson E. Use of tumescent mastectomy technique as a risk factor for native breast skin flap necrosis following immediate breast reconstruction. Am J Surg. 2011 Feb;201(2):160-5. doi: 10.1016/j.amjsurg.2009.12.011. Epub 2010 Apr 20. |
| 19644248 | Result | Antony AK, Mehrara BM, McCarthy CM, Zhong T, Kropf N, Disa JJ, Pusic A, Cordeiro PG. Salvage of tissue expander in the setting of mastectomy flap necrosis: a 13-year experience using timed excision with continued expansion. Plast Reconstr Surg. 2009 Aug;124(2):356-363. doi: 10.1097/PRS.0b013e3181aee9a3. |
| 1985335 | Result | Kroll SS, Ames F, Singletary SE, Schusterman MA. The oncologic risks of skin preservation at mastectomy when combined with immediate reconstruction of the breast. Surg Gynecol Obstet. 1991 Jan;172(1):17-20. |
| 17965954 | Result | Patani N, Mokbel K. Oncological and aesthetic considerations of skin-sparing mastectomy. Breast Cancer Res Treat. 2008 Oct;111(3):391-403. doi: 10.1007/s10549-007-9801-7. Epub 2007 Oct 28. |
| 12052757 | Result | Foster RD, Esserman LJ, Anthony JP, Hwang ES, Do H. Skin-sparing mastectomy and immediate breast reconstruction: a prospective cohort study for the treatment of advanced stages of breast carcinoma. Ann Surg Oncol. 2002 Jun;9(5):462-6. doi: 10.1007/BF02557269. |
| 19106672 | Result | Garwood ER, Moore D, Ewing C, Hwang ES, Alvarado M, Foster RD, Esserman LJ. Total skin-sparing mastectomy: complications and local recurrence rates in 2 cohorts of patients. Ann Surg. 2009 Jan;249(1):26-32. doi: 10.1097/SLA.0b013e31818e41a7. |
| 17084333 | Result | Sacchini V, Pinotti JA, Barros AC, Luini A, Pluchinotta A, Pinotti M, Boratto MG, Ricci MD, Ruiz CA, Nisida AC, Veronesi P, Petit J, Arnone P, Bassi F, Disa JJ, Garcia-Etienne CA, Borgen PI. Nipple-sparing mastectomy for breast cancer and risk reduction: oncologic or technical problem? J Am Coll Surg. 2006 Nov;203(5):704-14. doi: 10.1016/j.jamcollsurg.2006.07.015. Epub 2006 Sep 11. |
| 19015470 | Result | Crowe JP, Patrick RJ, Yetman RJ, Djohan R. Nipple-sparing mastectomy update: one hundred forty-nine procedures and clinical outcomes. Arch Surg. 2008 Nov;143(11):1106-10; discussion 1110. doi: 10.1001/archsurg.143.11.1106. |
| 27018703 | Derived | 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. |
| 26017589 | Derived | 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. |