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

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.

Study Overview

• Status: Unknown
• Conditions: Sensitivity of Nipple-areolar Complex
• Intervention / Treatment: Procedure: Section of Periareolar Dermis in Breast Reduction.

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jairo Z Sá, surgeon; Phone Number: +55 81 34675717; Email: jairozacche@gmail.com

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50670-607
      • Hospital das Clínicas da UFPE
      • Contact: Jairo Z Sá, surgeon; Phone Number: +55 81 34675717; Email: jairozacche@gmail.com
      • Principal Investigator: Jairo Z Sá, surgeon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Section of Periareolar Dermis	Procedure: Section of Periareolar Dermis in Breast Reduction.; Other Names: Decortication; Sensitivity; Nipple-Areolar Complex (NAC); Breast Reduction; Schwartzmann's Maneuver

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nipple-Areola Complex (NAC) Sensitivity	To evaluate the sensitivity of the NAC in breast reduction	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nipple-Areola Complex (NAC) sensitivity	To evaluate the sensitivity of the NAC in breast reduction	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nipple-Areola Complex sensitivity	To evaluate the sensitivity of the NAC in breast reduction	12 months

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco
• Investigators: Principal Investigator: Jairo Z Sá, surgeon, Hospital das Clínicas da Universidade Federal de Pernambuco

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: February 4, 2013
• First Submitted That Met QC Criteria: February 8, 2013
• First Posted (Estimate): February 12, 2013

Study Record Updates

• Last Update Posted (Estimate): April 29, 2013
• Last Update Submitted That Met QC Criteria: April 26, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: sensitivity; breast reduction; section of periareolar dermis
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: UFPE (CAAE N. 79139717.6.0000.5208)