Multicentric Risk Evaluation of Autologous Fat Grafting Procedure

• Conditions: Pain, Postoperative
• Interventions: Procedure: Breast reconstruction; Procedure: Autologous fat grafting procedure

• Registration Number: NCT04130373
• Lead Sponsor: Humanitas Clinical and Research Center

Brief Summary

Autologous fat grafting, also known as lipofilling, is a surgical technique consisting in the processing and transfer of adipose tissue from one area in our organism (hips, thighs) to region which in need of reconstructive and aesthetic correction. The technique is frequently used after radical or conservative mammary surgery, aiming to achieve better aesthetic results, reduce pain induced by both surgery and radiotherapy. The scientific community was widely involved in the debate regarding the use of mesenchymal/stem cells in a patient with high risk of tumor progression due to their elevated proliferative profile. This study aims to retrospectively evaluate the oncological safety in the use of lipofilling in patients who underwent oncological and reconstructive treatment in our Institute.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-01
• Status Verified: 2019-10
• Study First Submitted: 2019-10-15
• Study First Submitted QC: 2019-10-15
• Study First Posted: 2019-10-17
• Last Update Submitted: 2019-10-28
• Last Update Posted: 2019-10-30
• Primary Completion: 2020-01
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 6510

Inclusion Criteria

• female
• breast carcinoma (any histological type, carcinoma in situ included) treated with radical or conservative surgery
• group treated with lipofilling and group which didnt receive lipofilling
• timing: retrospective evaluation of cases form 2006 to 2016, with a minimum of two year follow up

Exclusion Criteria

• neoplasie different from infiltrating and in sutu breast carcinoma
• in situ lobular carcinoma
• patients with breast carcinoma and metastasis
• lipofilling procedure used before the oncological treatment for breast carcinoma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Breast reconstruction	Women who received breast reconstruction only.
Women receiving autologous fat grafting	Autologous fat grafting procedure	Women who received breast reconstruction and autologous fat grafting.
Women receiving autologous fat grafting	Breast reconstruction	Women who received breast reconstruction and autologous fat grafting.

Primary Outcome Measures

Name	Time	Method
Oncological safety of autologous fat grafting	Two years	Percentage of disease relapse in loco

Secondary Outcome Measures

Name	Time	Method
Establishment of timing in disease relapse	Two years
Establish overall survival rate in experimental and control groups	Two years
Establish the distribution in disease relapses	Two years	Establish the distribution in disease relapse in thre different histological subtypes of breast carcinoma

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milan, Italy