Nipple-Areola Complex Sensitivity After the Section of Periareolar Dermis in Breast Reduction
Primary Purpose
Sensitivity of Nipple-areolar Complex
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Section of Periareolar Dermis in Breast Reduction.
Sponsored by
About this trial
This is an interventional treatment trial for Sensitivity of Nipple-areolar Complex focused on measuring sensitivity, section of periareolar dermis, breast reduction
Eligibility Criteria
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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;
- Patients with autoimmune disease;
- Menopausal patients
- Patients with collagen disease;
- Patients with psychiatric disorders.
Sites / Locations
- Hospital das clínicas da UFPE
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Section of Periareolar Dermis
Arm Description
Section of Periareolar Dermis
Outcomes
Primary Outcome Measures
Nipple-Areola Complex (NAC) Sensitivity
To evaluate the sensitivity of the NAC in breast reduction
Secondary Outcome Measures
Nipple-Areola Complex (NAC) sensitivity
To evaluate the sensitivity of the NAC in breast reduction
Full Information
NCT ID
NCT01789450
First Posted
February 4, 2013
Last Updated
April 26, 2013
Sponsor
Universidade Federal de Pernambuco
1. Study Identification
Unique Protocol Identification Number
NCT01789450
Brief Title
Nipple-Areola Complex Sensitivity After the Section of Periareolar Dermis in Breast Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensitivity of Nipple-areolar Complex
Keywords
sensitivity, section of periareolar dermis, breast reduction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Section of Periareolar Dermis
Arm Type
Experimental
Arm Description
Section of Periareolar Dermis
Intervention Type
Procedure
Intervention Name(s)
Section of Periareolar Dermis in Breast Reduction.
Other Intervention Name(s)
Sensitivity, Nipple-Areolar Complex (NAC), Breast Reduction, Schwartzmann's Maneuver, Decortication
Primary Outcome Measure Information:
Title
Nipple-Areola Complex (NAC) Sensitivity
Description
To evaluate the sensitivity of the NAC in breast reduction
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Nipple-Areola Complex (NAC) sensitivity
Description
To evaluate the sensitivity of the NAC in breast reduction
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Nipple-Areola Complex sensitivity
Description
To evaluate the sensitivity of the NAC in breast reduction
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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;
Exclusion Criteria:
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;
Patients with autoimmune disease;
Menopausal patients
Patients with collagen disease;
Patients with psychiatric disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jairo Z Sá, surgeon
Phone
81 34675717
Ext
+55
Email
jairozacche@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jairo Z Sá, surgeon
Organizational Affiliation
Hospital das Clínicas da Universidade Federal de Pernambuco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das clínicas da UFPE
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50670-607
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jairo Z Sá, surgeon
Phone
81 34675717
Ext
+55
Email
jairozacche@gmail.com
First Name & Middle Initial & Last Name & Degree
Jairo Z Sá, surgeon
12. IPD Sharing Statement
Learn more about this trial
Nipple-Areola Complex Sensitivity After the Section of Periareolar Dermis in Breast Reduction
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