Immediate Breast Reconstruction With Hybrid Fat Transfer

NCT ID: NCT05190809

Last Updated: 2022-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-04-01

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

Conditions

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Breast Appearance Reconstruction Disproportion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study group

Group of female patients who will undergo Goldilocks mastectomy in which they will receive an autologous fat grafting in the remaining breast flaps

Group Type EXPERIMENTAL

Goldilocks mastectomy and fat transfer

Intervention Type PROCEDURE

Skin sparing mastectomy (Goldilocks mastectomy), then autologous fat grafting in the medial and lateral breast pillars as well as the inferior dermal flap

Interventions

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Goldilocks mastectomy and fat transfer

Skin sparing mastectomy (Goldilocks mastectomy), then autologous fat grafting in the medial and lateral breast pillars as well as the inferior dermal flap

Intervention Type PROCEDURE

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role collaborator

Abouqir General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abouzaid

Dr. Ahmed Mohamed Abouzaid

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Abouqir General Hospital

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Ahmed M Abouzaid, MsC

Role: primary

01224567862 ext. +2

Mahmoud A. El Hussini

Role: backup

Other Identifiers

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0304743

Identifier Type: -

Identifier Source: org_study_id

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