Hybrid Autologous Breast Augmentation in Mastopexy With Internal BRA Fixation; Using Local Breast Tissues and Fat Grafting

NCT07197190 | Not Yet Recruiting

• 1 other identifier: Augmentation mastopexy
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The breast is a very important organ for women's self-esteem and is regarded as a symbol of femininity. Deviations from normal size, shape, and symmetry are interpreted as unattractive and a sign of aging. Far from posing merely a cosmetic problem, such deviations deeply disturb both the patient's perception of her body and her emotional balance. The first breast surgeries started as early as the 6th century, yet the aesthetic breast surgeries and specifically mastopexy techniques were first recorded in the 19th century in parallel with the evolution of reduction mammaplasty. Most of these techniques involved suspension targeting breast mound elevation. Breast ptosis refers to the downward displacement of the nipple-areola complex (NAC) below the inframammary fold (IMF), commonly due to aging, pregnancy, weight fluctuations, and genetics. It's caused by loss of skin elasticity, stretching of Cooper's ligaments, parenchymal involution, and genetic factors. The degree of ptosis can be categorized by the Regnault classification, which assesses the breast according to the relative position of the nipple to the inframammary fold (IMF): Grade 1: Mild ptosis - The nipple is at the level of the IMF. Grade 2: Moderate ptosis - The nipple is below the level of the IMF but is not the most dependent part of the breast. Grade 3: Severe ptosis - The nipple is below the IMF and is the most dependent part of the breast. Pseudoptosis designates a breast configuration in which the nipple is located above or at the level of the IMF, most of the breast is well below the IMF, and the nipple-to-IMF distance is often greater than 6 cm. Mastopexy procedures are similar and traditionally derived from reduction procedures, involving skin resection with no or minimal parenchymal resection. There are three main surgical goals that should be attained to correct breast ptosis and give a firm aesthetic breast shape. These include nipple areola complex (NAC) elevation, skin envelope excess management and breast reshaping. Breast flaps and parenchymal shaping manoeuvres can help auto augmentation correct any shape defects, Hence come the idea of autogenous internal bra mastopexy technique. The term 'internal bra' refers to a range of techniques that aim to stabilise the position of the breast and improve longevity of surgical results. They can be categorised into 5 groups: mesh techniques, acellular dermal matrix (ADMs) techniques, suture techniques, dermal flap techniques, and muscle techniques. In this study, the investigators address one of the dermal flap techniques. Dermal flaps have two key advantages compared to meshes and ADMs, the first of which is that they are low cost due to their autologous nature The fact that they utilise the patient's own tissue also means they are not associated with an increased risk of infection or immunological reaction, which is their second main advantage. There are many different types of pedicled flaps in mastopexy as medial, superior and superomedial flaps. But in this study, the investigators use the superior pedicelled flap with inferior dermal flap described by Liacyr Ribeiro. This flap can be better mobilized than any of the other flaps, and the breast and the flap move together. The flap does not heal to pectoralis fascia; rather, the anterior surface of the flap heals to the posterior surface of the pedicle. Later, if the patient decides to have an implant, there is still a good plane between the pectoralis fascia and the inferior flap. This plane could be filled by sub pectoral fascia fat grafting. Autologous augmentation mastopexy may seem the most suitable technique for ptotic small sized breasts. But it has some drawbacks on the long term, such as upper pole hollowness. This issue can also be addressed by upper pole fullness by fat grafting. So, in this research, the investigators do autologous internal bra mastopexy with fat grafting in two planes: Sub- fascial level for augmentation and subcutaneous level for upper pole fullness. The investigators assess the result by taking pre and post operative breast measurements and photographs. The investigators also assess participants' satisfaction level and possible complication.

Conditions

Breast Ptosis

Keywords

Internal Bra; Sub-pectoral lipofilling; Autologous Augmentation mastpexy; Breast fat grafting

Outcome Measures

Primary Outcomes (3)

• Photpgraphs

  Photographs were taken for each patient in anterior, oblique and lateral views.

  Preoperative, postoperative and 6- month follow-up.

• Breast measurements.

  Breast measurements while standing in a lateral position include 1. Suprasternal notch to nipple (SN-N) 2. Inframammary fold distance. 3. Base width 4. Areola diameter 5. Inter-nipple distance. 6. nipple to inframammary fold (N-IMF). 7. Upper pole projection. 8. Lateral maximum projection. 9. Humerus length. Finally, circumference measurements were obtained at three different levels: upper pole, level of maximum projection and at the level of IMF.

  Pre- operative, post operative and 6- month follow up.

• Patient statisification level

  Patient statisification level is measured using a breast q questionaire. The improvement postoperative is measured by increased statisification and quality of life than preoperative assessment.

  Pre-operative, postoperative and after 6 month.

Study Arms (1)

Female patient with breast ptosis, grade 2 or 3, with small or medium sized breast.

EXPERIMENTAL

\- Study subjects: 1. Inclusion criteria: 1. Female patient 2. Grade 2 or 3 breast ptosis according to Regnault classification. 3. Age is between 18 years and 50 years old. 4. Small to moderate breast size. 2. Exclusion criteria: 1. Age is below 18 years and above 50 years. 2. Pregnant or breast-feeding patient. 3. Large sized breast. 4. Grade 1 breast ptosis or pseudoptosis according to Regnault classification. 5. Patients are currently under treatment of breast cancer. 6. Immunosuppressed patients. They are all subjected to autologous augmentation mastopexy with subpectoral lipofilling and upper and medial pole fat grafting.

Procedure: Autologous augmentation mastopexy with subpectoral lipofilling and upper and medial pole fat grafting.

Interventions

Autologous augmentation mastopexy with subpectoral lipofilling and upper and medial pole fat grafting. PROCEDURE

The term 'internal bra' refers to a range of techniques that aim to stabilise the position of the breast and improve longevity of surgical results. In this study, the investigators address one of them which is dermal flap technique. Dermal flaps have two key advantages, the first of which is that they are low cost due to their autologous nature. The fact that they utilise the patient's own tissue also means they are not associated with an increased risk of infection or immunological reaction, which is their second main advantage, But it has some drawbacks on the long term, such as upper pole hollowness and lack of breast parenchymal tissue to give a good breast volume. In this research, the investigators used the autogenous internal BRA mastopexy technique for correction of breast ptosis and sub pectoral lipofilling to help increase the breast volume and subcutaneous fat grafting to give the breast upper pole fullness.

Female patient with breast ptosis, grade 2 or 3, with small or medium sized breast.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patient
• Grade 2 or 3 breast ptosis according to Regnault classification.
• Age is between 18 years and 50 years old.
• Small to moderate breast size.

You may not qualify if:

• Age is below 18 years and above 50 years.
• Pregnant or breast-feeding patient.
• Large sized breast.
• Grade 1 breast ptosis or pseudoptosis according to Regnault classification.
• Patients are currently under treatment of breast cancer.
• Immunosuppressed patients. -

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut unversity Hospitals

Asyut, Asyut Governorate, Egypt

Location

Related Links

• Breast Q test, the measurement tool for patients' statisfication.

Central Study Contacts

Alaa M Elhawary, Masters

CONTACT

0201096778330; alaaelhawary@med.aun.edu.eg

Wael Saadeldin Professor, MD

CONTACT

0201005395056; waelsaadeldeen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Plastic surgery Specialist

Study Record Dates

• First Submitted: September 20, 2025
• First Posted: September 29, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)