search
Back to results

Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis

Primary Purpose

Mastectomy Flap Necrosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
nitroglycerin ointment
Polysporin ointment
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mastectomy Flap Necrosis

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Saint Joseph Hospital
  • Vancouver General Hospital
  • University of British Columbia Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Polysporin Control

Nitroglycerin

Arm Description

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

Patients in treatment group will receive nitroglycerin ointment application

Outcomes

Primary Outcome Measures

Mastectomy Flap Necrosis

Secondary Outcome Measures

Full Information

First Posted
May 28, 2012
Last Updated
September 8, 2014
Sponsor
University of British Columbia
search

1. Study Identification

Unique Protocol Identification Number
NCT01608880
Brief Title
Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis
Official Title
Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mastectomy Flap Necrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polysporin Control
Arm Type
Placebo Comparator
Arm Description
Patients in control group will receive polysporin ointment application. Polysporin ointment will be made to look like Nitroglycerin ointment.
Arm Title
Nitroglycerin
Arm Type
Active Comparator
Arm Description
Patients in treatment group will receive nitroglycerin ointment application
Intervention Type
Drug
Intervention Name(s)
nitroglycerin ointment
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Polysporin ointment
Intervention Description
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 Outcome Measure Information:
Title
Mastectomy Flap Necrosis
Time Frame
1 month post operative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheina Macadam, MD, MSc, FRCSC
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Perry Gdalevitch, MD, FRCSC
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Saint Joseph Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5T 3N4
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
University of British Columbia Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21542401
Citation
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.
Results Reference
result
PubMed Identifier
8331946
Citation
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.
Results Reference
result
PubMed Identifier
6427801
Citation
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.
Results Reference
result
PubMed Identifier
1447671
Citation
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.
Results Reference
result
PubMed Identifier
9215351
Citation
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.
Results Reference
result
PubMed Identifier
17054170
Citation
Nelson R. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD003431. doi: 10.1002/14651858.CD003431.pub2.
Results Reference
result
PubMed Identifier
16526822
Citation
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.
Results Reference
result
PubMed Identifier
19939277
Citation
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.
Results Reference
result
PubMed Identifier
18580145
Citation
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.
Results Reference
result
PubMed Identifier
20409522
Citation
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.
Results Reference
result
PubMed Identifier
19644248
Citation
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.
Results Reference
result
PubMed Identifier
1985335
Citation
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.
Results Reference
result
PubMed Identifier
17965954
Citation
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.
Results Reference
result
PubMed Identifier
12052757
Citation
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.
Results Reference
result
PubMed Identifier
19106672
Citation
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.
Results Reference
result
PubMed Identifier
17084333
Citation
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.
Results Reference
result
PubMed Identifier
19015470
Citation
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.
Results Reference
result
PubMed Identifier
27018703
Citation
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.
Results Reference
derived
PubMed Identifier
26017589
Citation
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.
Results Reference
derived

Learn more about this trial

Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis

We'll reach out to this number within 24 hrs