Nipple-Areola Complex Sensitivity After the Section of Periareolar Dermis in Breast Reduction

NCT ID: NCT01789450

Last Updated: 2013-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-06-30

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.

Conditions

Sensitivity of Nipple-areolar Complex

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Section of Periareolar Dermis

Section of Periareolar Dermis

Group Type: EXPERIMENTAL

Section of Periareolar Dermis in Breast Reduction.

Intervention Type: PROCEDURE

Interventions

Section of Periareolar Dermis in Breast Reduction.

Intervention Type: PROCEDURE

Other Intervention Names

Sensitivity; Nipple-Areolar Complex (NAC); Breast Reduction; Schwartzmann's Maneuver; Decortication

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal de Pernambuco

OTHER

Sponsor Role: lead

Responsible Party

Jairo Zacchê de Sá

Jairo Zacchê de Sá

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jairo Z Sá, surgeon

Role: PRINCIPAL_INVESTIGATOR

Hospital das Clínicas da Universidade Federal de Pernambuco

Locations

Hospital das clínicas da UFPE

Recife, Pernambuco, Brazil

Countries

Brazil

Central Contacts

Jairo Z Sá, surgeon

Role: CONTACT

jairozacche@gmail.com

81 34675717 ext. +55

Facility Contacts

Jairo Z Sá, surgeon

Role: primary

jairozacche@gmail.com

81 34675717 ext. +55

Other Identifiers

UFPE

Identifier Type: -

Identifier Source: org_study_id