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SKINI - Radicality of Skin-Sparing and Nipple-Sparing Mastectomy

NCT03470909 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2018-03-21

No results posted yet for this study

Summary

Prospective collection of health related personal data and biological material (tissue biopsy) in patients undergoing mastectomy.

Conditions

  • Surgery

Interventions

PROCEDURE

Skin-Sparing Mastectomy (SSM)

For patients undergoing SSM, 10 points of interest in radial localization have been selected for investigation of the presence of residual breast tissue. The points are located under the remaining skin envelope and will be investigated by performing small biopsies with a cervical biopsy forceps. Additionally, the distance between the surface of the specimen and the glandular tissue will be explored at five points at the base of the removed breast. These histological sections will be radially oriented.

PROCEDURE

Nipple-Sparing Mastectomy (NSM)

For patients undergoing NSM, 14 points of interest in radial localization have been selected for investigation of the presence of residual breast tissue, i.e. comparing to SSM, 4 additional biopsies will be taken behind the peripheral part of the areola. The points are located under the remaining skin envelope and will be investigated by performing small biopsies with a cervical biopsy forceps. Additionally, the distance between the surface of the specimen and the glandular tissue will be explored at five points at the base of the removed breast. These histological sections will be radially oriented.

Sponsors & Collaborators

  • Brust-Zentrum AG

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-12
Primary Completion
2017-08-04
Completion
2017-08-04

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03470909 on ClinicalTrials.gov