Immediate Breast Reconstruction With Hybrid Fat Transfer

Study Overview
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Brief Summary
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Investigators in this study describe a new perspective for female patients that will undergo skin-sparing mastectomy in which there will be an immediate reconstruction of the mastectomized breast for more satisfactory aesthetic results.

Detailed Description
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This study introduces a new perspective for women who will undergo mastectomy especially Goldilocks mastectomy in which the investigators do fat grafting to the medial and lateral pillars of the breast as well as the inferior dermal flap in order to have a voluminous remaining breast shape that is close enough in size with the contralateral breast for more aesthetic results and to observe the lipografted tissue reaction after radiotherapy

Official Title
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Immediate Breast Reconstruction With Hybrid Fat Transfer: Prospective Single-arm Interventional Study

Conditions
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Breast Appearance Reconstruction Disproportion

Intervention / Treatment
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* Procedure: Goldilocks mastectomy and fat transfer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients Age 20 - 65 years old females with unilateral breast malignancy candidate for Goldilocks mastectomy procedure Exclusion Criteria: Females with ages beyond the study frame. Females refusing to participate Fameles that not accepting the liposuction, lipofilling procedure Females with contralateral previously operated or mastectomized breast.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Group of female patients who will undergo Goldilocks mastectomy in which they will receive an autologous fat grafting in the remaining breast flaps | Procedure: Goldilocks mastectomy and fat transfer<br>* Skin sparing mastectomy (Goldilocks mastectomy), then autologous fat grafting in the medial and lateral breast pillars as well as the inferior dermal flap<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate breast reconstruction and equalizing the operated breast cup size with the no-operated breast cup size | fat grafting to the Goldilocks mastectomy flaps to have the mastectomized breast cup size to be aesthetically close to the contralateral non-operated breast cup size, also 5 point Likert scale was used to evaluate the patient satisfaction | 6 months follow up post-surgical | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the skin changes and the trophic effect of radiotherapy on the fat grafted tissue | observe and evaluate the skin changes to the skin flaps of the mastectomy side after radiotherapy and evaluate if the fat grafted tissue can resist the trophic effect of radiotherapy | through the radiotherapy course and 1 month after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Goldilocks Mastectomy, Fat grafting, Breast reconstruction, skin sparing mastectomy