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

Sensitivity of Nipple-areolar Complex Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01789450
• Other study ID #: UFPE
• Status: Not yet recruiting
• Phase: N/A
• First received: February 4, 2013
• Last updated: April 26, 2013
• Start date: June 2013
• Est. completion date: June 2015

Study information

• Verified date: April 2013
• Source: Universidade Federal de Pernambuco
• Contact: Jairo Z Sá, surgeon
• Phone: 81 34675717
• Email: jairozacche[@]gmail.com
• Is FDA regulated: No
• Health authority: Brasil: Plataforma Brasil
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sensitivity of Nipple-areolar Complex

Intervention

Procedure:
• Section of Periareolar Dermis in Breast Reduction.

Locations

Country	Name	City	State
Brazil	Hospital das clínicas da UFPE	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nipple-Areola Complex sensitivity	To evaluate the sensitivity of the NAC in breast reduction	12 months	No
Primary	Nipple-Areola Complex (NAC) Sensitivity	To evaluate the sensitivity of the NAC in breast reduction	3 weeks	No
Secondary	Nipple-Areola Complex (NAC) sensitivity	To evaluate the sensitivity of the NAC in breast reduction	6 weeks	No