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

NCT06147661 | Unknown

• 1 other identifier: 8954
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Implants

Keywords

Breast Prosthesis; Breast Implants

Outcome Measures

Primary Outcomes (1)

• Patient woman satisfaction

  This satisfaction will be assessed using a remote satisfaction interview

  1 to 4 years after breast implants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Chirurgie Plastique, Reconstructrice et Esthétique - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

Central Study Contacts

Frédéric BODIN, MD, PhD

CONTACT

33 3 68 76 51 67; frederic.bodin@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 27, 2023
• Study Start: June 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 22, 2024
• Last Updated: November 27, 2023

Record last verified: 2023-10

Locations

FR (1)