Breast Appearance Reconstruction DisproportionNCT05190809
Immediate Breast Reconstruction With Hybrid Fat Transfer
A study testing Goldilocks mastectomy and fat transfer in people with Breast Appearance Reconstruction Disproportion, run by Abouqir General Hospital at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Breast Appearance Reconstruction Disproportion
- What is being tested?
- Goldilocks mastectomy and fat transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients
- Age 20 - 65 years old
- females with unilateral breast malignancy
- candidate for Goldilocks mastectomy procedure
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Abouqir General Hospital
Alexandria, 21527
Ahmed M Abouzaid, MsC, 01224567862 ext. +2, dr.mhossiny@yahoo.com
Mahmoud A. El Hussini
About this study
Official title: 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.
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
- Being tested
- Goldilocks mastectomy and fat transfer
- Keywords
- Goldilocks Mastectomy, Fat grafting, Breast reconstruction, skin sparing mastectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goldilocks mastectomy and fat transferProcedure or surgery
Skin sparing mastectomy (Goldilocks mastectomy), then autologous fat grafting in the medial and lateral breast pillars as well as the inferior dermal flap
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Group of female patients who will undergo Goldilocks mastectomy in which they will receive an autologous fat grafting in the remaining breast flaps Receives: Procedure: Goldilocks mastectomy and fat transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: through the radiotherapy course and 1 month after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Oct 2021
- Primary completion31 Jan 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Appearance Reconstruction DisproportionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abouqir General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Principal investigator, Ahmed Mohamed Abouzaid, Abouqir General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190809
- Sponsor's protocol ID
- 0304743
- Status last verified
- Jan 2022
- First submitted
- 21 Dec 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Breast Reconstruction With Hybrid Fat Transfer: Prospective Single-arm Interventional Study
- ClinicalTrials.gov ID
- NCT05190809
- Acronym / sponsor ID
- 0304743
- Keywords
- Goldilocks Mastectomy, Fat grafting, Breast reconstruction, skin sparing mastectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Abouqir General HospitalUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Goldilocks mastectomy and fat transferGroup of female patients who will undergo Goldilocks mastectomy in which they will receive an autologous fat grafting in the remaining breast flaps |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients
- Age 20 - 65 years old
- females with unilateral breast malignancy
- candidate for Goldilocks mastectomy procedure
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goldilocks mastectomy and fat transferSkin sparing mastectomy (Goldilocks mastectomy), then autologous fat grafting in the medial and lateral breast pillars as well as the inferior dermal flap | Procedure or surgery | Study group |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goldilocks mastectomy and fat transfer in people with Breast Appearance Reconstruction Disproportion, run by Abouqir General Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.