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

Surgery Clinical Trial

Official title:
SKINI - Prospective Evaluation of the Radicality of Breast Tissue Removal With Skin-Sparing and Nipple-Sparing Mastectomy (SSM or NSM)

Clinical Trial Summary

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

Clinical Trial Description

In this prospective, multi-center trial patients undergoing mastectomy and fulfilling inclusion criteria receive additional biopsies from the remaining skin envelope in order to quantify the amount of residual breast tissue.

Since the investigators will assess, 142 breasts will be investigated. This means a maximum of n=142 patients will be included (corresponding to a minimum of n=71 patient).

On the specimen additional histological sections in radial direction will be performed.

The aim of the study is to evaluate the quality of Skin- Sparing and Nipple-Sparing Mastectomy. On each predefined location in the wound cavity the investigators will investigate where residual breast tissue (RBT) will be found or not. If no RBT can be detected at all predefined breast locations this breast will be classified as having no RBT (=RBT negative). If breast tissue can be detected the investigators have a RBT positive breast. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03470909
Study type Interventional
Source Brust-Zentrum AG
Contact
Status Completed
Phase N/A
Start date April 12, 2016
Completion date August 4, 2017
View Details
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