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

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT06147661
Collaborator
(none)
119
Enrollment
1
Location
7.7
Anticipated Duration (Months)
15.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    119 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Primary Aesthetic Breast Augmentation: Comparative Study Between Breast Implants and Autograft of Adipose Tissue
    Actual Study Start Date :
    Jun 1, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Jan 22, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Patient woman satisfaction [1 to 4 years after breast implants]

      This satisfaction will be assessed using a remote satisfaction interview

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Chirurgie Plastique, Reconstructrice et Esthétique - CHU de Strasbourg - France Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT06147661
    Other Study ID Numbers:
    • 8954
    First Posted:
    Nov 27, 2023
    Last Update Posted:
    Nov 27, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Breast Prosthesis
    Breast Implants

    Study Results

    No Results Posted as of Nov 27, 2023