- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01789450
Nipple-Areola Complex Sensitivity After the Section of Periareolar Dermis in Breast Reduction
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Pernambuco
-
Recife, Pernambuco, Brasilien, 50670-607
- Hospital das clínicas da UFPE
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Section of Periareolar Dermis
|
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Nipple-Areola Complex (NAC) Sensitivity
Tidsramme: 3 weeks
|
To evaluate the sensitivity of the NAC in breast reduction
|
3 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Nipple-Areola Complex (NAC) sensitivity
Tidsramme: 6 weeks
|
To evaluate the sensitivity of the NAC in breast reduction
|
6 weeks
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Nipple-Areola Complex sensitivity
Tidsramme: 12 months
|
To evaluate the sensitivity of the NAC in breast reduction
|
12 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Jairo Z Sá, surgeon, Hospital das Clínicas da Universidade Federal de Pernambuco
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UFPE (CAAE N. 79139717.6.0000.5208)
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