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Immediate Breast Reconstruction With Hybrid Fat Transfer

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05190809
Enrollment
25
Registered
2022-01-13
Start date
2021-10-01
Completion date
2022-04-01
Last updated
2022-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Appearance Reconstruction Disproportion

Keywords

Goldilocks Mastectomy, Fat grafting, Breast reconstruction, skin sparing mastectomy

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

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

Sponsors

Alexandria University
CollaboratorOTHER
Abouqir General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Immediate breast reconstruction and equalizing the operated breast cup size with the no-operated breast cup size6 months follow up post-surgicalfat 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

MeasureTime frameDescription
Evaluate the skin changes and the trophic effect of radiotherapy on the fat grafted tissuethrough the radiotherapy course and 1 month afterobserve 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026