Assiut unversity Hospitals
Asyut, Asyut Governorate, Egypt
NCT Number: NCT07197190
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.
Trial opening soon.
Get Notified18 year–50 year
Female
Interventional
Not applicable
Asyut, Asyut Governorate, Egypt
*Aim of work: To achieve breast autologous internal BRA mastopexy in grade 2 and 3 breast ptosis using, auto-augmentation with tissue rearrangement, sub pectoral fascia fat grafting and upper pole lipofilling. And 6-month long follow-up to observe participants' satisfaction level, measurements and complications.
*Patients and Methods: A primary prospective randomized control trial. 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 and medium sized breast. Exclusion criteria
Personal History: Name, age, sex, Job, Marital status, co-morbidities and smoking.
Preoperative investigations: blood count, coagulation profile, basic metabolic panel and mammograms.
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Surgical procedure:
Then the flap was transposed superiorly, and three separate sutures were taken between upper borders of flap and pectoralis muscle and fascia using polypropylene 1 or zero.
Liposuction and fat harvesting procedure:
For each 500 cc of Ringer solution, the investigators add 1 mL of epinephrine and 10 cc of 2% Lidocaine.
3*Postoperative Care
4*Post-operative data:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Preoperative, postoperative and 6- month follow-up.
Photographs were taken for each patient in anterior, oblique and lateral views.
Time frame: Pre- operative, post operative and 6- month follow up.
Breast measurements while standing in a lateral position include
Time frame: Pre-operative, postoperative and after 6 month.
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.
Contact information is provided by the study sponsor or research team.
Alaa M Elhawary, Masters
CONTACT
Wael Saadeldin Professor, MD
CONTACT
Assiut University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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