Immediate Breast Reconstruction With Hybrid Fat Transfer

Not Applicable

• Conditions: Breast Appearance Reconstruction Disproportion
• Interventions: Procedure: Goldilocks mastectomy and fat transfer

• Registration Number: NCT05190809
• Lead Sponsor: Abouqir General Hospital

Brief Summary

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

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

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2021-12-21
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-12
• Last Update Submitted: 2022-01-12
• Study First Posted: 2022-01-13
• Last Update Posted: 2022-01-13
• Primary Completion: 2022-01-31
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Goldilocks mastectomy and fat transfer	Group of female patients who will undergo Goldilocks mastectomy in which they will receive an autologous fat grafting in the remaining breast flaps

Primary Outcome Measures

Name	Time	Method
Immediate breast reconstruction and equalizing the operated breast cup size with the no-operated breast cup size	6 months follow up post-surgical	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

Secondary Outcome Measures

Name	Time	Method
Evaluate the skin changes and the trophic effect of radiotherapy on the fat grafted tissue	through the radiotherapy course and 1 month after	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

Trial Locations

Locations (1)

Abouqir General Hospital; 🇪🇬 Alexandria, Egypt