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Status unknownNCT05190809Updated Jan 13, 2022

Immediate Breast Reconstruction With Hybrid Fat Transfer

An interventional study of Goldilocks mastectomy and fat transfer in Breast Appearance Reconstruction Disproportion, sponsored by Abouqir General Hospital. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-01-13.

Sponsored by Abouqir General Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
20 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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

02

Conditions studied

  • Breast Appearance Reconstruction Disproportion

Keywords

  • Goldilocks Mastectomy
  • Fat grafting
  • Breast reconstruction
  • skin sparing mastectomy
03

In context

Lead sponsor

Abouqir General Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Female patients
  • Age 20 - 65 years old
  • females with unilateral breast malignancy
  • candidate for Goldilocks mastectomy procedure

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureGoldilocks 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months follow up post-surgical

Secondary outcomes

  1. 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

    Time frame: through the radiotherapy course and 1 month after

07

Study locations

1 of 1 sites recruiting
  • Abouqir General Hospital
    Alexandria, 21527, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05190809
Lead sponsor
Abouqir General Hospital
Collaborators
Alexandria University
Responsible party
Ahmed Mohamed Abouzaid (Dr. Ahmed Mohamed Abouzaid, Abouqir General Hospital) — Principal investigator
First posted
Jan 13, 2022
Start date
Oct 1, 2021
Primary completion
Jan 31, 2022 (estimated)
Completion
Apr 1, 2022 (estimated)
Last update
Jan 13, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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