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

Breast Implants Clinical Trial

— AMEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06147661
• Other study ID #: 8954
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: January 22, 2024

Study information

• Verified date: October 2023
• Source: University Hospital, Strasbourg, France
• Contact: Frédéric BODIN, MD, PhD
• Phone: 33 3 68 76 51 67
• Email: frederic.bodin[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 119
• Est. completion date: January 22, 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Implants

Locations

Country	Name	City	State
France	Service de Chirurgie Plastique, Reconstructrice et Esthétique - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient woman satisfaction	This satisfaction will be assessed using a remote satisfaction interview	1 to 4 years after breast implants