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Multicentric Risk Evaluation of Autologous Fat Grafting Procedure

H

Humanitas Clinical and Research Center

Status

Unknown

Conditions

Pain, Postoperative

Treatments

Procedure: Breast reconstruction
Procedure: Autologous fat grafting procedure

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

6,510 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

6,510 participants in 2 patient groups

Women receiving autologous fat grafting
Description:
Women who received breast reconstruction and autologous fat grafting.
Treatment:
Procedure: Autologous fat grafting procedure
Procedure: Breast reconstruction
Control
Description:
Women who received breast reconstruction only.
Treatment:
Procedure: Breast reconstruction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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