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Clinical Trials/NCT06147661
NCT06147661RecruitingNot Applicable

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

University Hospital, Strasbourg, France1 site in 1 country119 target enrollmentStarted: June 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
119
Locations
1
Primary Endpoint
Patient woman satisfaction

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Patient woman satisfaction

Time Frame: 1 to 4 years after breast implants

This satisfaction will be assessed using a remote satisfaction interview

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital, Strasbourg, France
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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