Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis

NCT01608880 | Completed DMC

• 1 other identifier: H12-01161
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 3

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.

Conditions

Mastectomy Flap Necrosis

Outcome Measures

Primary Outcomes (1)

• Mastectomy Flap Necrosis

  1 month post operative

Study Arms (2)

Polysporin Control

PLACEBO COMPARATOR

Patients in control group will receive polysporin ointment application. Polysporin ointment will be made to look like Nitroglycerin ointment.

Drug: Polysporin ointment

Nitroglycerin

ACTIVE COMPARATOR

Patients in treatment group will receive nitroglycerin ointment application

Drug: nitroglycerin ointment

Interventions

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)

Nitroglycerin

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.

Polysporin Control

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (3)

Mount Saint Joseph Hospital

Vancouver, British Columbia, V5T 3N4, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

University of British Columbia Hospital

Vancouver, British Columbia, V6T 2B5, Canada

Location

Related Publications (19)

• 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.

  PMID: 21542401 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.

  PMID: 8331946 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.

  PMID: 6427801 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.

  PMID: 1447671 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.

  PMID: 9215351 RESULT

• Nelson R. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD003431. doi: 10.1002/14651858.CD003431.pub2.

  PMID: 17054170 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.

  PMID: 16526822 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.

  PMID: 19939277 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.

  PMID: 18580145 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.

  PMID: 20409522 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.

  PMID: 19644248 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.

  PMID: 1985335 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.

  PMID: 17965954 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.

  PMID: 12052757 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.

  PMID: 19106672 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.

  PMID: 17084333 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.

  PMID: 19015470 RESULT

• 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.

  PMID: 27018703 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.

  PMID: 26017589 DERIVED

MeSH Terms

Interventions

polysporin ointment

Study Officials

• Sheina Macadam, MD, MSc, FRCSC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Perry Gdalevitch, MD, FRCSC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2012
• First Posted: May 31, 2012
• Study Start: August 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 10, 2014

Record last verified: 2014-09

Locations

CA (3)