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Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis

NCT01608880 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2014-09-10

No results posted yet for this study

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

Interventions

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)

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.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Sheina Macadam, MD, MSc, FRCSC · University of British Columbia

  • Perry Gdalevitch, MD, FRCSC · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-03-31
Completion
2014-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01608880 on ClinicalTrials.gov