Mastectomy Flap NecrosisNCT01608880
Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis
A study testing nitroglycerin ointment and Polysporin ointment in people with Mastectomy Flap Necrosis, run by University of British Columbia at 3 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Mastectomy Flap Necrosis
- What is being tested?
- nitroglycerin ointment and Polysporin ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 3 sitesCanada
- Study dates
- Aug 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Mount Saint Joseph Hospital
Vancouver, British Columbia, V5T 3N4
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
University of British Columbia Hospital
Vancouver, British Columbia, V6T 2B5
About this study
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.
Read more
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
- Being tested
- nitroglycerin ointment, Polysporin ointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nitroglycerin ointmentDrug
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)
Polysporin ointmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Polysporin Control | Placebo comparator | Patients in control group will receive polysporin ointment application. Polysporin ointment will be made to look like Nitroglycerin ointment. Receives: Drug: Polysporin ointment |
| Nitroglycerin | Active comparator | Patients in treatment group will receive nitroglycerin ointment application Receives: Drug: nitroglycerin ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mastectomy Flap Necrosis
Measured: 1 month post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Mastectomy Flap NecrosisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheina Macadam, MD, MSc, FRCSC, Principal investigator, University of British ColumbiaPerry Gdalevitch, MD, FRCSC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608880
- Sponsor's protocol ID
- H12-01161
- Status last verified
- Sep 2014
- First submitted
- 28 May 2012
- Last updated
- 10 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21542401Fan 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.
PubMed 8331946Rohrich 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.
PubMed 6427801Wong 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.
PubMed 1447671Jones 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.
PubMed 9215351Nelson R. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD003431. doi: 10.1002/14651858.CD003431.pub2.
PubMed 17054170Fenton 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.
PubMed 16526822Rao 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.
PubMed 19939277Losken 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.
PubMed 18580145Chun 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.
PubMed 20409522Antony 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.
PubMed 19644248Kroll 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.
PubMed 1985335Patani 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.
PubMed 17965954Foster 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.
PubMed 12052757Garwood 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.
PubMed 19106672
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis
- ClinicalTrials.gov ID
- NCT01608880
- Acronym / sponsor ID
- H12-01161
- Conditions
- Mastectomy Flap Necrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 31 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polysporin Control | Placebo comparator | Drug: Polysporin ointmentPatients in control group will receive polysporin ointment application. Polysporin ointment will be made to look like Nitroglycerin ointment. |
| Nitroglycerin | Active comparator | Drug: nitroglycerin ointmentPatients in treatment group will receive nitroglycerin ointment application |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nitroglycerin ointmentNitroglycerin 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 | Nitroglycerin |
| Polysporin ointmentPolysporin 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. | Drug | Polysporin Control |
Primary outcome
Mastectomy Flap Necrosis
Time frame: 1 month post operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2014.
- Results publication: PubMed 21542401Kutun 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 publication: PubMed 8331946Fan 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 publication: PubMed 6427801Rohrich 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 publication: PubMed 1447671Wong 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 publication: PubMed 9215351Jones 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 publication: PubMed 17054170Nelson R. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD003431. doi: 10.1002/14651858.CD003431.pub2.
- Results publication: PubMed 16526822Fenton 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 publication: PubMed 19939277Rao 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 publication: PubMed 18580145Losken 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 publication: PubMed 20409522Chun 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 publication: PubMed 19644248Antony 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 publication: PubMed 1985335Kroll 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.
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Prophylactic Mastectomy: Prospective Evaluation of the Correlation Between Skin Flap Thickness, Residual Glandular Tissue and Skin Necrosis by Imaging and Clinical Examination
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheina Macadam, MD, MSc, FRCSC principal investigator
University of British Columbia
Perry Gdalevitch, MD, FRCSC principal investigator
University of British Columbia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nitroglycerin ointment and Polysporin ointment in people with Mastectomy Flap Necrosis, run by University of British Columbia at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mastectomy Flap Necrosis (time frame: 1 month post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01608880, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2014.