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

Not Applicable

• Conditions: Sensitivity of Nipple-areolar Complex
• Interventions: Procedure: Section of Periareolar Dermis in Breast Reduction.

• Registration Number: NCT01789450
• Lead Sponsor: Universidade Federal de Pernambuco

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.

Study Timeline

• Study First Submitted: 2013-02-04
• Study First Submitted QC: 2013-02-08
• Study First Posted: 2013-02-12
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-26
• Last Update Posted: 2013-04-29
• Study Start: 2013-06
• Primary Completion: 2014-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Section of Periareolar Dermis	Section of Periareolar Dermis in Breast Reduction.	Section of Periareolar Dermis

Primary Outcome Measures

Name	Time	Method
Nipple-Areola Complex (NAC) Sensitivity	3 weeks	To evaluate the sensitivity of the NAC in breast reduction

Secondary Outcome Measures

Name	Time	Method
Nipple-Areola Complex (NAC) sensitivity	6 weeks	To evaluate the sensitivity of the NAC in breast reduction

Trial Locations

Locations (1)

Hospital das clínicas da UFPE; 🇧🇷 Recife, Pernambuco, Brazil