Breast CancerNCT02938390
Localization of Intercostal Perforating Vessels Reduces Wound Complications From Nipple Sparing Mastectomy
An observational study of Breast Cancer, run by Amita Health at 1 site in United States.
Trial summary
Approximately 100 women scheduled for NSM will be consented pre-operatively to participate in the study. US will be performed after induction of general anesthesia, prior to surgery using Sonosite™ portable US, 5-12mHz transducer using doppler mode. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ultrasound for localizing intercostal perforating vessels
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Dec 2021
- Phase
- Observational
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female subjects scheduled for nipple sparing mastectomy.
Who may be able to join
- Females 18 years of age or older
- Planned nipple sparing mastectomy
Who cannot join
- Contraindication to nipple sparing mastectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
AMITA Health Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
About this study
Official title: Ultrasound Localization of Intercostal Perforating Vessels Reduces Post-Operative Wound Complications From Nipple Sparing Mastectomy
Approximately 100 women scheduled for NSM will be consented pre-operatively to participate in the study. US will be performed after induction of general anesthesia, prior to surgery using Sonosite™ portable US, 5-12mHz transducer using doppler mode.
Read the detailed description
Nipple Sparing Mastectomy (NSM) has been increasingly utilized over the last ten years for risk-reducing surgery and surgical treatment for breast cancer. The oncologic safety has been well established in multiple studies in appropriately selected individuals. Additionally, rates of wound complications and risk factors for wound problems are well documented. The intercostal perforating vessels (IPV) have been demonstrated to provide a significant proportion of the blood supply to the nipple-areolar complex1-3. Thus, preservation of these vessels is essential to reducing ischemic necrosis of the nipple-areolar complex. We propose that localization of these vessels utilizing intra-operative ultrasound (US) will reduce ischemic necrosis complications of NSM.
Objectives
- Demonstrate that US is an effective means of localizing the IPV intraoperatively.
- Evaluate the frequency of IPV preservation with the use of US.
- Measure rate and severity of ischemic necrosis when US is utilized to preserve IPV.
- Compare observed rate with historical controls.
- Conditions
- Breast Cancer
- Being tested
- Ultrasound for localizing intercostal perforating vessels
- Keywords
- Nipple Sparing Mastectomy, Ultrasound
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound for localizing intercostal perforating vesselsProcedure or surgery
Use of an Intra-operative ultrasound during nipple sparing mastectomy to localize intercostal perforating vessels.
What is being measured
The primary outcome is the main question the study is designed to answer.
Localization of the intercostal perforating vessels utilizing intra-operative ultrasound (US) will reduce ischemic necrosis complications of nipple sparing mastectomy.
Measured: At the time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2020
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amita Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Maganini, MD, Amita Health
- Investigators
- Robert O Maganini, MD, Principal investigator, Amita Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938390
- Sponsor's protocol ID
- Nipple Sparing Study
- Status last verified
- Jan 2021
- First submitted
- 18 Oct 2016
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Palmer JH, Taylor GI. The vascular territories of the anterior chest wall. Br J Plast Surg. 1986 Jul;39(3):287-99. doi: 10.1016/0007-1226(86)90037-8.
PubMed 3730674Lemaine V, Hoskin TL, Farley DR, Grant CS, Boughey JC, Torstenson TA, Jacobson SR, Jakub JW, Degnim AC. Introducing the SKIN score: a validated scoring system to assess severity of mastectomy skin flap necrosis. Ann Surg Oncol. 2015 Sep;22(9):2925-32. doi: 10.1245/s10434-015-4409-3. Epub 2015 Jan 30.
PubMed 25634782
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Localization of Intercostal Perforating Vessels Reduces Post-Operative Wound Complications From Nipple Sparing Mastectomy
- ClinicalTrials.gov ID
- NCT02938390
- Acronym / sponsor ID
- Nipple Sparing Study
- Conditions
- Breast Cancer
- Keywords
- Nipple Sparing Mastectomy, Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Amita HealthUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 19 Oct 2016 (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.
Approximately 100 women scheduled for NSM will be consented pre-operatively to participate in the study. US will be performed after induction of general anesthesia, prior to surgery using Sonosite™ portable US, 5-12mHz transducer using doppler mode.
Detailed description
Nipple Sparing Mastectomy (NSM) has been increasingly utilized over the last ten years for risk-reducing surgery and surgical treatment for breast cancer. The oncologic safety has been well established in multiple studies in appropriately selected individuals. Additionally, rates of wound complications and risk factors for wound problems are well documented. The intercostal perforating vessels (IPV) have been demonstrated to provide a significant proportion of the blood supply to the nipple-areolar complex1-3. Thus, preservation of these vessels is essential to reducing ischemic necrosis of the nipple-areolar complex. We propose that localization of these vessels utilizing intra-operative ultrasound (US) will reduce ischemic necrosis complications of NSM.
Objectives
- Demonstrate that US is an effective means of localizing the IPV intraoperatively.
- Evaluate the frequency of IPV preservation with the use of US.
- Measure rate and severity of ischemic necrosis when US is utilized to preserve IPV.
- Compare observed rate with historical controls.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female subjects scheduled for nipple sparing mastectomy.
Key inclusion criteria (2 listed)
- Females 18 years of age or older
- Planned nipple sparing mastectomy
Key exclusion criteria (1 listed)
- Contraindication to nipple sparing mastectomy
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 |
|---|---|---|
| Ultrasound for localizing intercostal perforating vesselsUse of an Intra-operative ultrasound during nipple sparing mastectomy to localize intercostal perforating vessels. | Procedure or surgery | – |
Primary outcome
Localization of the intercostal perforating vessels utilizing intra-operative ultrasound (US) will reduce ischemic necrosis complications of nipple sparing mastectomy.
Time frame: At the time of procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Background: PubMed 3730674Palmer JH, Taylor GI. The vascular territories of the anterior chest wall. Br J Plast Surg. 1986 Jul;39(3):287-99. doi: 10.1016/0007-1226(86)90037-8.
- Background: PubMed 25634782Lemaine V, Hoskin TL, Farley DR, Grant CS, Boughey JC, Torstenson TA, Jacobson SR, Jakub JW, Degnim AC. Introducing the SKIN score: a validated scoring system to assess severity of mastectomy skin flap necrosis. Ann Surg Oncol. 2015 Sep;22(9):2925-32. doi: 10.1245/s10434-015-4409-3. Epub 2015 Jan 30.
- Individual participant dataSharing planned: Yes
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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.
Robert O Maganini, MD principal investigator
Amita Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Amita Health at 1 site in United States.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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?
Results are not available in the source record.
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?
Localization of the intercostal perforating vessels utilizing intra-operative ultrasound (US) will reduce ischemic necrosis complications of nipple sparing mastectomy. (time frame: At the time of procedure). 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 NCT02938390, which also lists 2 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 14 Jan 2021.