Sensitivity of Nipple-areolar ComplexNCT01789450
Nipple-Areola Complex Sensitivity After the Section of Periareolar Dermis in Breast Reduction
A study testing Section of Periareolar Dermis in Breast Reduction. in people with Sensitivity of Nipple-areolar Complex, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the feasibility and sensitivity of nipple-areolar complex (NAC) prospectively due to the section of the dermis after decortication (Schwartzmann's maneuver), in 50 patients undergoing breast reduction surgery. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sensitivity of Nipple-areolar Complex
- What is being tested?
- Section of Periareolar Dermis in Breast Reduction.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2013to Jun 2015
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who willingly seek the service requesting breast reduction or mastopexy;
- Patients who after consultation with the surgeon who led the research presents realistic expectation, being safe with the possible outcome of the surgery;
- Patients who undertake to comply with the protocol previously presented and discussed with them;
Who cannot join
- Patients with prior breast surgery;
- Patients with body mass index (BMI) greater than 34.9;
- Patients with severe anemia;
- Patients with neurological disease;
- Patients with impairment cardiovascular;
- Metabolic diseases - diabetes;
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- Patients with autoimmune disease;
- Menopausal patients
- Patients with collagen disease;
- Patients with psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das clínicas da UFPE
Recife, Pernambuco, 50670-607
Jairo Z Sá, surgeon, 81 34675717 ext. +55, jairozacche@gmail.com
Jairo Z Sá, surgeon
About this study
The purpose of this study is to evaluate the feasibility and sensitivity of nipple-areolar complex (NAC) prospectively due to the section of the dermis after decortication (Schwartzmann's maneuver), in 50 patients undergoing breast reduction surgery.
Read the detailed description
Preservation of the dermis after decortication regions of the areola and periareolar is considered relevant by most plastic surgeons.
In patients whose CAP should be mobilized through large distances in order to correct breast ptosis, or in cases of dense breasts where noted little slip of skin over the breast parenchyma, the periareolar dermis causes limitation on the mobility of the NAC.
In clinical practice, there is a greater mobilization of NAC when making a careful section of the dermis after decortication. In contrast, the appearance of partial necrosis in these cases has become a rarity, as no case of total necrosis was observed.
Given the technical benefit observed due to greater mobilization, there is no report in the literature about how behaves the sensitivity of the NAC in these cases.
To evaluate the sensitivity of the NAC will be used Semmes-Weisnstein's monofilament. Each point will be obtained five measurements. The largest will be scorned and the lowest value. The final value of each point corresponds to an arithmetic mean of the three remaining values.
- Conditions
- Sensitivity of Nipple-areolar Complex
- Being tested
- Section of Periareolar Dermis in Breast Reduction.
- Keywords
- sensitivity, section of periareolar dermis, breast reduction
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Section of Periareolar Dermis in Breast Reduction.Procedure or surgery
Also called Sensitivity, Nipple-Areolar Complex (NAC), Breast Reduction, Schwartzmann's Maneuver
| Study group | Role | What they receive |
|---|---|---|
| Section of Periareolar Dermis | Experimental | Section of Periareolar Dermis Receives: Procedure: Section of Periareolar Dermis in Breast Reduction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nipple-Areola Complex (NAC) Sensitivity
To evaluate the sensitivity of the NAC in breast reduction
Measured: 3 weeks
Secondary outcomes (1)
Nipple-Areola Complex (NAC) sensitivity
To evaluate the sensitivity of the NAC in breast reduction
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitivity of Nipple-areolar ComplexStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jairo Zacchê de Sá, Federal University of São Paulo
- Investigators
- Jairo Z Sá, surgeon, Principal investigator, Hospital das Clínicas da Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789450
- Sponsor's protocol ID
- UFPE
- Status last verified
- Apr 2013
- First submitted
- 4 Feb 2013
- Last updated
- 29 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nipple-Areola Complex Sensitivity After the Section of Periareolar Dermis in Breast Reduction
- ClinicalTrials.gov ID
- NCT01789450
- Acronym / sponsor ID
- UFPE
- Conditions
- Sensitivity of Nipple-areolar Complex
- Keywords
- sensitivity, section of periareolar dermis, breast reduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 12 Feb 2013 (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.
The purpose of this study is to evaluate the feasibility and sensitivity of nipple-areolar complex (NAC) prospectively due to the section of the dermis after decortication (Schwartzmann's maneuver), in 50 patients undergoing breast reduction surgery.
Detailed description
Preservation of the dermis after decortication regions of the areola and periareolar is considered relevant by most plastic surgeons.
In patients whose CAP should be mobilized through large distances in order to correct breast ptosis, or in cases of dense breasts where noted little slip of skin over the breast parenchyma, the periareolar dermis causes limitation on the mobility of the NAC.
In clinical practice, there is a greater mobilization of NAC when making a careful section of the dermis after decortication. In contrast, the appearance of partial necrosis in these cases has become a rarity, as no case of total necrosis was observed.
Given the technical benefit observed due to greater mobilization, there is no report in the literature about how behaves the sensitivity of the NAC in these cases.
To evaluate the sensitivity of the NAC will be used Semmes-Weisnstein's monofilament. Each point will be obtained five measurements. The largest will be scorned and the lowest value. The final value of each point corresponds to an arithmetic mean of the three remaining values.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Section of Periareolar Dermis | Experimental | Procedure: Section of Periareolar Dermis in Breast Reduction.Section of Periareolar Dermis |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients who willingly seek the service requesting breast reduction or mastopexy;
- Patients who after consultation with the surgeon who led the research presents realistic expectation, being safe with the possible outcome of the surgery;
- Patients who undertake to comply with the protocol previously presented and discussed with them;
Key exclusion criteria (10 listed)
- Patients with prior breast surgery;
- Patients with body mass index (BMI) greater than 34.9;
- Patients with severe anemia;
- Patients with neurological disease;
- Patients with impairment cardiovascular;
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 |
|---|---|---|
| Section of Periareolar Dermis in Breast Reduction.Also: Sensitivity, Nipple-Areolar Complex (NAC), Breast Reduction, Schwartzmann's Maneuver | Procedure or surgery | Section of Periareolar Dermis |
Primary outcome
Nipple-Areola Complex (NAC) Sensitivity
Time frame: 3 weeks
To evaluate the sensitivity of the NAC in breast reduction
1 secondary outcome
Nipple-Areola Complex (NAC) sensitivity
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2013.
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.
Jairo Z Sá, surgeon principal investigator
Hospital das Clínicas da Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Section of Periareolar Dermis in Breast Reduction. in people with Sensitivity of Nipple-areolar Complex, run by Universidade Federal de Pernambuco at 1 site in Brazil.
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 10 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 29 Apr 2013. 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 Brazil. 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?
Contact Jairo Z Sá, surgeon (81 34675717 ext. +55, jairozacche@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nipple-Areola Complex (NAC) Sensitivity (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2013.