Clinical Outcomes of Patients Undergoing Skin-Reducing Mastectomies

NCT06133452 | Completed

• 1 other identifier: UID 4357
• Study Type: observational
• Target: 398
• Locations: 1 country
• Sites: 1

Brief Summary

The "mastectomy skin reducing" is a surgical procedure involving the removal of the mammary gland and, simultaneously, reducing the excess skin to enhance the aesthetic appearance in breast reconstruction. This technique is commonly used in patients with an excessive amount of residual skin after breast tissue removal, such as following a mastectomy for breast cancer treatment or prophylactic purposes (in patients at high risk of breast carcinoma due to family history and/or mutations in the Breast Cancers genes ). The goal of mastectomy skin reducing is to create a breast reconstruction that appears natural and aesthetically harmonious by minimizing excess skin. Excess skin can be removed in two main ways: as a conventional ellipse around the nipple-areola complex or, preferably, as part of an inverted "T"-shaped incision, commonly used in reduction mammoplasty. This procedure adheres to oncological principles of skin-conserving mastectomy and also incorporates a lower dermal flap, used to create a dermo-muscular pocket that reinforces the coverage of the prosthetic implant. The primary indication for mastectomy skin reducing is when a patient has excessively large (hypertrophic) and sagging (ptotic) breasts. In these cases, removing excess skin and breast tissue during mastectomy contributes to creating a solid foundation for breast reconstruction and improving the aesthetics of the reconstructed breast. The purpose of this retrospective study is to provide accurate data on the clinical outcomes of mastectomy skin reducing performed at the European Oncology Institute in Milan. This study is part of a larger project involving patients with breast cancer and/or carriers of mutations in the Breast Cancer genes who have undergone mastectomy skin reducing in the last 5 years.

Conditions

Breast Cancer

Keywords

skin reducing mastectomy; breast cancer

Outcome Measures

Primary Outcomes (2)

• rate of short term complications

  hematoma, seroma, bleeding, infections, necrosis, prothesis exposure,Prothesis Explantations

  60 months

• rate of long term complications

  Seroma, Infections, Necrosis, Prothesis Explantations,prothesis exposure

  60 months

Secondary Outcomes (1)

• rate of refinements

  60 months

Interventions

skin reducing mastectomy PROCEDURE

The goal of mastectomy skin reducing is to create a breast reconstruction that appears natural and aesthetically harmonious by minimizing excess skin. Excess skin can be removed in two main ways: as a conventional ellipse around the nipple-areola complex or, preferably, as part of an inverted "T"-shaped incision, commonly used in reduction mammoplasty. This procedure adheres to oncological principles of skin-conserving mastectomy and also incorporates a lower dermal flap, used to create a dermo-muscular pocket that reinforces the coverage of the prosthetic implant. This technique allows complete detachment of the pectoral muscle at the bottom while ensuring full coverage of the prosthetic implant with a dermo-muscular layer. By increasing the implant pocket and providing an additional tissue layer at the bottom of the breast, this technique can reduce the risk of complications and improve aesthetic outcomes.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

breast cancer affected and/or High risk breast cancer ( BRCA1 and/or 2 mutated) women with moderate-large Brest underwent to skin reducing mastectomy.

You may qualify if:

• breast cancer affected women with moderate-large Breast underwent to skin reducing mastectomy.
• High risk breast cancer ( BRCA1 and/or 2 mutated) women with moderate-large Breast underwent to skin reducing mastectomy.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

Istituto Europeo di Oncologia

Milan, Lombardy, 20132, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Andrea Vittorio Emanuele Lisa, MD

  Istituto Europeo di Oncologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 60 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 15, 2023
• Study Start: January 7, 2018
• Primary Completion: April 2, 2023
• Study Completion: October 1, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-10

Locations

IT (1)