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

NACompletedINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

April 12, 2016

Primary Completion Date

August 4, 2017

Study Completion Date

August 4, 2017

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."

Trial Locations (1)

8008

Brust-Zentrum AG, Zurich

All Listed Sponsors
lead

Brust-Zentrum AG

OTHER

NCT03470909 - SKINI - Radicality of Skin-Sparing and Nipple-Sparing Mastectomy | Biotech Hunter | Biotech Hunter