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Multicentric Risk Evaluation of Autologous Fat Grafting Procedure

Multicentic Retrospective Evaluation of Risks in Mammary Carcinoma Relapse in Patients With Mammary Reconstruction and Autologous Fat Grafting

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04130373
Enrollment
6510
Registered
2019-10-17
Start date
2019-06-01
Completion date
2020-06-30
Last updated
2019-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

Autologous fat grafting, Lipofilling, Breast cancer, Breast reconstruction

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.

Interventions

PROCEDUREAutologous fat grafting procedure

Surgical intervention based on the injection of autologous fat grafting after radical or conservative breast surgery and breast reconstruction.

PROCEDUREBreast reconstruction

Breast reconstructive procedures after oncological radical or conservative breast surgery

Sponsors

Humanitas Clinical and Research Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Oncological safety of autologous fat graftingTwo yearsPercentage of disease relapse in loco

Secondary

MeasureTime frameDescription
Establishment of timing in disease relapseTwo years
Establish the distribution in disease relapsesTwo yearsEstablish the distribution in disease relapse in thre different histological subtypes of breast carcinoma
Establish overall survival rate in experimental and control groupsTwo years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026