Immediate Breast Reconstruction With Hybrid Fat Transfer

January 12, 2022 updated by: Ahmed Mohamed Abouzaid, Abouqir General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21527
        • Recruiting
        • Abouqir General Hospital
        • Contact:
        • Contact:
          • Mahmoud A. El Hussini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: 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

What is the study measuring?

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
Time Frame: 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
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
Time Frame: 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
through the radiotherapy course and 1 month after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abouqir General Hospital

Collaborators

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Anticipated)

January 31, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

December 21, 2021

First Submitted That Met QC Criteria

January 12, 2022

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Actual)

January 13, 2022

Last Update Submitted That Met QC Criteria

January 12, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0304743

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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