Multicentric Risk Evaluation of Autologous Fat Grafting Procedure

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04130373
• Other study ID #: 1955K
• Status: Active, not recruiting
• Start date: June 1, 2019
• Est. completion date: June 2020

Study information

• Verified date: October 2019
• Source: Humanitas Clinical and Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6510
• Est. completion date: June 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• Autologous fat grafting procedure
Surgical intervention based on the injection of autologous fat grafting after radical or conservative breast surgery and breast reconstruction.
• Breast reconstruction
Breast reconstructive procedures after oncological radical or conservative breast surgery

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Humanitas Clinical and Research Center

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oncological safety of autologous fat grafting	Percentage of disease relapse in loco	Two years
Secondary	Establishment of timing in disease relapse		Two years
Secondary	Establish the distribution in disease relapses	Establish the distribution in disease relapse in thre different histological subtypes of breast carcinoma	Two years
Secondary	Establish overall survival rate in experimental and control groups		Two years