Immediate Breast Reconstruction With Hybrid Fat Transfer

Sponsor

Abouqir General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05190809

Collaborator

Alexandria University (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Appearance Reconstruction Disproportion	Procedure: Goldilocks mastectomy and fat transfer	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Jan 31, 2022

Anticipated Study Completion Date :

Apr 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abouqir General Hospital	Alexandria		Egypt	21527

Sponsors and Collaborators

Abouqir General Hospital
Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Mohamed Abouzaid, Dr. Ahmed Mohamed Abouzaid, Abouqir General Hospital

ClinicalTrials.gov Identifier:

NCT05190809

Other Study ID Numbers:

0304743

First Posted:

Jan 13, 2022

Last Update Posted:

Jan 13, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ahmed Mohamed Abouzaid, Dr. Ahmed Mohamed Abouzaid, Abouqir General Hospital

Goldilocks Mastectomy

Fat grafting

Breast reconstruction

skin sparing mastectomy

Study Results

No Results Posted as of Jan 13, 2022