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

Brust-Zentrum AG

Status

Completed

Conditions

Surgery

Treatments

Procedure: Skin-Sparing Mastectomy (SSM)

Procedure: Nipple-Sparing Mastectomy (NSM)

Study type

Interventional

Funder types

Other

Identifiers

NCT03470909

2016-01191

Details and patient eligibility

About

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

Full 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.

Enrollment

160 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients undergoing uni- or bilateral Skin-Sparing or Nipple-Sparing mastectomy
Female participants ≥ 18 years of age
The subject was informed on the project and gave her written informed consent to use her data and samples for this project.

Exclusion criteria