Primary Aesthetic Breast Augmentation: Comparative Study Between Breast Implants and Autograft of Adipose Tissue (AMEP)

November 22, 2023 updated by: University Hospital, Strasbourg, France

The use of autograft of adipose tissue for aesthetic breast augmentation is increasing year after year. According to the latest meta-analysis of 2016, autograft of adipose tissue in augmentation mastoplasty seems to be a promising method with a satisfactory resorption volume and patient and surgeon satisfaction. However, this technique allows for small to moderate breast augmentation and is therefore not suitable for patients wanting a significant increase.

Breast prostheses allow a significant increase. Numerous studies have shown an improvement in patient satisfaction and quality of life assessed using the BREAST-Q questionnaire.

On the other hand, very few studies have objectively evaluated the satisfaction of patients who have benefited from an autograft of adipose tissue as part of aesthetic breast augmentation. No study has yet compared the satisfaction of patients who have benefited from breast implants or lipofilling.

The aim of this study is to compare the satisfaction of patients who have benefited from breast augmentation by prosthesis or by lipofilling using a remote satisfaction interview.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

119

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Chirurgie Plastique, Reconstructrice et Esthétique - CHU de Strasbourg - France
        • Contact:
        • Contact:
        • Principal Investigator:
          • Frédéric BODIN
        • Principal Investigator:
          • Anna AUQUE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult woman (age ≥ 18 years) having benefited from primary aesthetic breast augmentation at Strasbourg University Hospital between June 27, 2017 and June 27, 2022

Description

Inclusion Criteria:

  • Adult woman (age ≥ 18 years)
  • having benefited from primary aesthetic breast augmentation at Strasbourg University Hospital between June 27, 2017 and June 27, 2022
  • not opposing the reuse of its data for scientific research purposes.

Exclusion Criteria:

  • Woman who expressed her opposition to the reuse of her data for scientific research purposes
  • Woman with a breast malformation: tuberous breasts or breast asymmetry of more than one cup
  • Woman with comprehension difficulties
  • Woman under guardianship or curatorship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient woman satisfaction
Time Frame: 1 to 4 years after breast implants
This satisfaction will be assessed using a remote satisfaction interview
1 to 4 years after breast implants

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 22, 2024

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

November 22, 2023

First Posted (Actual)

November 27, 2023

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 8954

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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