Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala

Ingia / Ingia

Kiungo kimehifadhiwa kwenye clipboard

HaliImekamilika

Wadhamini

University of British Columbia

JARIBIO LA KLINIKI: NCT01608880

BioSeek: nct01608880

Maneno muhimu

Kikemikali

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.

Tarehe

Imethibitishwa Mwisho:	08/31/2014
Iliyowasilishwa Kwanza:	05/27/2012
Uandikishaji uliokadiriwa Uliwasilishwa:	05/29/2012
Iliyotumwa Kwanza:	05/30/2012
Sasisho la Mwisho Liliwasilishwa:	09/07/2014
Sasisho la Mwisho Lilichapishwa:	09/09/2014
Tarehe halisi ya kuanza kwa masomo:	07/31/2012
Tarehe ya Kukamilisha Msingi iliyokadiriwa:	02/28/2014
Tarehe ya Kukamilisha Utafiti:	05/31/2014

Hali au ugonjwa

Mastectomy Flap Necrosis

Uingiliaji / matibabu

Drug: Nitroglycerin

Drug: Polysporin Control

Awamu

Vikundi vya Arm

Mkono	Uingiliaji / matibabu
Placebo Comparator: Polysporin Control Patients in control group will receive polysporin ointment application. Polysporin ointment will be made to look like Nitroglycerin ointment.	Drug: Polysporin Control 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.
Active Comparator: Nitroglycerin Patients in treatment group will receive nitroglycerin ointment application	Drug: Nitroglycerin 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)

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza	21 Years Kwa 21 Years
Jinsia Inastahiki Kujifunza	Female
Hupokea Wajitolea wa Afya	Ndio
Vigezo	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

Matokeo

Hatua za Matokeo ya Msingi

1. Mastectomy Flap Necrosis [1 month post operative]