NCT03470909

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Brust-Zentrum AG · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Surgery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-04-12
• Primary completion: 2017-08-04
• Completion: 2017-08-04
• First posted: 2018-03-20
• Last updated: 2018-03-21

Locations

1 site across 1 country: Switzerland