Clinical trial NCT01789450: Nipple-Areola Complex Sensitivity After the Section of Periareolar Dermis in Breast Reduction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sensitivity of Nipple-areolar Complex
Keywords: sensitivity
section of periareolar dermis
breast reduction
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2013-02-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Nipple-Areola Complex (NAC) Sensitivity
timeFrame: 3 weeks
Secondary outcomes:
measure: Nipple-Areola Complex (NAC) sensitivity
timeFrame: 6 weeks
Other outcomes:
measure: Nipple-Areola Complex sensitivity
timeFrame: 12 months
Locations:
city: Recife
country: Brazil
facility: Hospital das clínicas da UFPE
state: Pernambuco
Study officials:
affiliation: Hospital das Clínicas da Universidade Federal de Pernambuco
name: Jairo Z Sá, surgeon
role: PRINCIPAL_INVESTIGATOR
References: