Multicentric Risk Evaluation of Autologous Fat Grafting Procedure

NCT ID: NCT04130373

Last Updated: 2019-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

6510 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-06-30

Brief Summary

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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

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Conditions

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Pain, Postoperative

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Women receiving autologous fat grafting

Women who received breast reconstruction and autologous fat grafting.

Autologous fat grafting procedure

Intervention Type PROCEDURE

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

Breast reconstruction

Intervention Type PROCEDURE

Breast reconstructive procedures after oncological radical or conservative breast surgery

Control

Women who received breast reconstruction only.

Breast reconstruction

Intervention Type PROCEDURE

Breast reconstructive procedures after oncological radical or conservative breast surgery

Interventions

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Autologous fat grafting procedure

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

Intervention Type PROCEDURE

Breast reconstruction

Breast reconstructive procedures after oncological radical or conservative breast surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Humanitas Clinical and Research Center

OTHER

Sponsor Role lead

Responsible Party

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Andrea Lisa

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marco Klinger, MD

Role: STUDY_CHAIR

Istituto Clinico Humanitas

Locations

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Istituto Clinico Humanitas

Rozzano, Milan, Italy

Site Status

Countries

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Italy

Other Identifiers

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1955K

Identifier Type: -

Identifier Source: org_study_id

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