Breast PtosisNCT06262724
Breast Reshaping Following Massive Weight Loss
A study testing Breast auto-augmentation in people with Breast Ptosis, run by Ain Shams University at 1 site in Egypt.
Trial summary
Reliability of Chest Wall Perforator Flaps for Breast Reshaping following Massive Weight Loss Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Ptosis
- What is being tested?
- Breast auto-augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 1 Jan 2024
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-45 years old.
- Weight:
- Loss of 50% or greater of excess weight, following surgical or non-surgical interventions (MWL).
- Stable weight for at least 6 months, to achieve metabolic and nutritional homeostasis and decrease the risk of surgical complications (Rubin et al., 2004).
- BMI: 18.5 - 30 kg/m2.
- Ptotic and deflated breasts with Pittsburgh Rating Scale (PRS) score 2-3 (Song, et al., 2005).
- Patients seeking autologous augmentation or refusing implants.
- Patients requiring simultaneous contouring of lateral chest wall redundancy.
Who cannot join
- Weight fluctuations in the previous 6 months.
- Medical co-morbidities (e.g., uncontrolled diabetes, uncontrolled hypertension, thyroid diseases, hormonal disturbances, cardiopulmonary diseases).
- Hereditary conditions that affect wound healing (e.g., Ehler Danlos Syndrome, Progeria).
- Active smokers (Smokers are required to stop smoking 1 month before surgery).
- Nutritional deficiencies (e.g., iron, vitamin B12, protein, folate).
- Previous breast surgery.
Show all 10Show fewer
- Congenital breast deformity (e.g., tuberous breasts).
- Breast masses.
- Pregnant or lactating patients.
- PRS score 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability of Chest Wall Perforator Flaps for Breast Reshaping Following Massive Weight Loss
Reliability of Chest Wall Perforator Flaps for Breast Reshaping following Massive Weight Loss
Read the detailed description
Conditions for inclusion in the study:
- Ptotic and deflated breasts following massive weight loss (MWL) with Pittsburgh Rating Scale (PRS) score of 2-3 as described by Songet al. (Song AY, Jean RD, Hurwitz D, Fernstrom MH, Scott JA, Rubin JP. A Classification of Contour Deformities after Bariatric Weight Loss: The Pittsburgh Rating Scale. Plast Reconstr Surg. 2005;116:1535-1544).
- MWL is defined as loss of 50% or greater of excess weight, following surgical or non-surgical interventions.
- Stable weight for at least 6 months, to achieve metabolic and nutritional homeostasis and decrease the risk of surgical complications.
- Body mass index (BMI): 18.5 - 30 kg/m2.
- Patients seeking autologous augmentation or refusing implants.
- Patients requiring simultaneous contouring of lateral chest wall redundancy.
Exclusion Criteria:
- Weight fluctuations in the previous 6 months.
- Medical co-morbidities (e.g., uncontrolled diabetes, uncontrolled hypertension, thyroid diseases, hormonal disturbances, cardiopulmonary diseases).
- Hereditary conditions that affect wound healing (e.g., Ehler Danlos Syndrome, Progeria).
- Active smokers (Smokers are required to stop smoking 1 month before surgery).
- Nutritional deficiencies (e.g., iron, vitamin B12, protein, folate).
- Previous breast surgery.
- Congenital breast deformity (e.g., tuberous breasts).
- Breast masses.
- Pregnant or lactating patients.
Local breast examination:
- Skin dimpling and intertrigo.
- Masses.
- Axillary lymph nodes.
- Position of nipple areola complex (NAC) and degree of ptosis (Regnault classification).
- Parenchyma (PRS score)
- Skin laxity.
- Direct breast anthropometry (baseline measurements for comparison and to guide surgical intervention):
The following measurements were assessed as described by Quieregatto et al. (Quieregatto PR, Hochman B, Ferrara SF, Furtado F, Liebano R, Neto MS, Ferreira LM. Anthropometry of the Breast Region: How to Measure? Aesth Plast Surg. 2014; 38:344-349) to help in pre-operative planning and to be compared to post-operative results.
- Anatomical landmarks:
- AAL: Anterior axillary line
- MCP: Mid-clavicular plane
- MHP: Mid-humeral plane
- N: Nipple
- SN: Sternal notch
- IMF: Inframammary fold
- Linear measurements (using tape measure): (Ideal values described by Liu YJ, Thomson JG. Ideal Anthropomorphic Values of the Female Breast. Annals of Plastic Surgery. 2011;67(1), 7-11.):
- SN-N (21 cm)
- N-IMF (8 cm)
- N-N (21 cm)
Photographic assessment:
Seven standardized digital photographs were taken with the following parameters: Fixed camera settings, identical background and lighting and a tape on the floor to ensure that patients stand in the same place and the same room (Swanson E. A Measurement System and Ideal Breast Shape. Evidence-Based Cosmetic Breast Surgery. Springer, Cham. 2017;19-31.):
- Frontal view
- Left lateral view.
- Right lateral view.
- A view with 45° rotation to the left.
- A view with 45° rotation to the right.
- Left lateral view with arms up.
- Right lateral view with arms up.
Pre-operative mammography:
- To exclude pre-operative tumors, cysts, and fat necrosis.
- To assess pre-operative breast volume.
- To be compared to post-operative mammography.
Surgical technique:
- Pinch test of excess tissue in the lateral chest wall (donor flap).
- Mapping of the perforators by hand-held Doppler probe.
- Mastopexy and auto-augmentation (as described by Rubin JP, Khachi G. Mastopexy After Massive Weight Loss: Dermal Suspension and Selective Auto-Augmentation. Clinics in Plastic Surgery. 2008;35(1), 123-129.), which includes Wise Pattern with preservation of inferior and central pedicle, in addition to lateral extension to encompass the lateral chest wall skin roll.
- Intraoperative perforator marking (thoracodorsal artery perforator versus intercostal artery perforator).
- Flap transposition and anchoring to the chest wall by permanent sutures to the periosteum of the second rib for auto-augmentation and filling of the upper pole.
- Skin closure and surgical drains in the breast and donor site.
- Wound dressing and surgical bra.
- Post-operative follow-up: The patient was evaluated:
- During the first 48 hours: for hematoma, NAC compromise and drain removal according to amount and color (less than 50 cc/ serous) and then discharged.
- At postoperative day 7, 10, 14 and 21: to detect any complications such as seroma, wound dehiscence, infection (redness, hotness, tenderness, discharge).
Patient evaluation: Final results were documented at 6 and 12 months through:
- Direct breast anthropometry: To compare to pre-operative measurements, as well as assess the sustainability of the post-operative results.
- Mammography:
- To measure breast volume.
- For signs of fat necrosis (as described by Chala LF, de Barros N, de Camargo Moraes P, Endo E, Kim SJ, Pincerato KM, Carvalho FM, Cerri GG. Fat Necrosis of the Breast: Mammographic, Sonographic, Computed Tomography, and Magnetic Resonance Imaging Findings. Curr Probl Diagn Radiol. 2004;33(3):106-26.), which reflect partial or total flap loss: Oil cyst (radiolucent mass surrounded by a thin fibrous membrane). Fibrotic reaction (irregular spiculated density). Calcifications (thin-walled calcifications in oil cysts or coarse irregular calcifications with radiolucent areas interspersed between them).
- Photographic assessment (as before):
The pre and post-operative photos were analyzed by three plastic surgery consultants who were not involved in the study, through a PowerPoint presentation. Data provided by surgeons were grouped under three categories: poor, good or excellent. The inter-observer concordance rate was statistically calculated.
- Conditions
- Breast Ptosis
- Being tested
- Breast auto-augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast auto-augmentationProcedure or surgery
Single group assignment. All patients included were subjected to utilizing chest wall perforator flaps for breast reshaping.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Other | Surgical intervention for breast reshaping utilizing chest wall perforators for auto-augmentation. Receives: Procedure: Breast auto-augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of breast volume by sono-mammography
Use of sono-mammography to measure the breast volume in cubic centimetres preoperatively, after 6 months and after one year following surgery. The equation used to measure the breast volume was as follows:
Breast volume = π/4 × (W × H × C) where W = breast width, H = breast height, and C=compression thickness in craniocaudal mammography)
Measured: One year follow-up
Secondary outcomes (3)
Sternal notch to nipple distance
Measures of the distance between sternal notch and nipple in centimetres in both sides using tape preoperatively, after 6 months and one year following surgery
Measured: One-year follow-up
Nipple to inframammary fold distance
Measures of the distance between nipple and intramammary fold in centimetres in both sides using tape preoperatively, after 6 months and one year following surgery
Measured: One-year follow-up
Measure of nipple-to-nipple distance
Measure of the distance between both nipples in centimetres using tape preoperatively, after 6 months and one year following surgery
Measured: One-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Aug 2021
- Primary completion1 Aug 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast PtosisStudies 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
- Model description
- All patients were subjected to the same intervention.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amr AW Mabrouk, MD, Study director, Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262724
- Sponsor's protocol ID
- Perforator Flaps
- Status last verified
- Feb 2024
- First submitted
- 22 Jan 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Chest Wall Perforator Flaps for Breast Reshaping Following Massive Weight Loss
- ClinicalTrials.gov ID
- NCT06262724
- Acronym / sponsor ID
- Perforator Flaps
- Conditions
- Breast Ptosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 16 Feb 2024 (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.
Reliability of Chest Wall Perforator Flaps for Breast Reshaping following Massive Weight Loss
Detailed description
Conditions for inclusion in the study:
- Ptotic and deflated breasts following massive weight loss (MWL) with Pittsburgh Rating Scale (PRS) score of 2-3 as described by Songet al. (Song AY, Jean RD, Hurwitz D, Fernstrom MH, Scott JA, Rubin JP. A Classification of Contour Deformities after Bariatric Weight Loss: The Pittsburgh Rating Scale. Plast Reconstr Surg. 2005;116:1535-1544).
- MWL is defined as loss of 50% or greater of excess weight, following surgical or non-surgical interventions.
- Stable weight for at least 6 months, to achieve metabolic and nutritional homeostasis and decrease the risk of surgical complications.
- Body mass index (BMI): 18.5 - 30 kg/m2.
- Patients seeking autologous augmentation or refusing implants.
- Patients requiring simultaneous contouring of lateral chest wall redundancy.
Exclusion Criteria:
- Weight fluctuations in the previous 6 months.
- Medical co-morbidities (e.g., uncontrolled diabetes, uncontrolled hypertension, thyroid diseases, hormonal disturbances, cardiopulmonary diseases).
- Hereditary conditions that affect wound healing (e.g., Ehler Danlos Syndrome, Progeria).
- Active smokers (Smokers are required to stop smoking 1 month before surgery).
- Nutritional deficiencies (e.g., iron, vitamin B12, protein, folate).
- Previous breast surgery.
- Congenital breast deformity (e.g., tuberous breasts).
- Breast masses.
- Pregnant or lactating patients.
Local breast examination:
- Skin dimpling and intertrigo.
- Masses.
- Axillary lymph nodes.
- Position of nipple areola complex (NAC) and degree of ptosis (Regnault classification).
- Parenchyma (PRS score)
- Skin laxity.
- Direct breast anthropometry (baseline measurements for comparison and to guide surgical intervention):
The following measurements were assessed as described by Quieregatto et al. (Quieregatto PR, Hochman B, Ferrara SF, Furtado F, Liebano R, Neto MS, Ferreira LM. Anthropometry of the Breast Region: How to Measure? Aesth Plast Surg. 2014; 38:344-349) to help in pre-operative planning and to be compared to post-operative results.
- Anatomical landmarks:
- AAL: Anterior axillary line
- MCP: Mid-clavicular plane
- MHP: Mid-humeral plane
- N: Nipple
- SN: Sternal notch
- IMF: Inframammary fold
- Linear measurements (using tape measure): (Ideal values described by Liu YJ, Thomson JG. Ideal Anthropomorphic Values of the Female Breast. Annals of Plastic Surgery. 2011;67(1), 7-11.):
- SN-N (21 cm)
- N-IMF (8 cm)
- N-N (21 cm)
Photographic assessment:
Seven standardized digital photographs were taken with the following parameters: Fixed camera settings, identical background and lighting and a tape on the floor to ensure that patients stand in the same place and the same room (Swanson E. A Measurement System and Ideal Breast Shape. Evidence-Based Cosmetic Breast Surgery. Springer, Cham. 2017;19-31.):
- Frontal view
- Left lateral view.
- Right lateral view.
- A view with 45° rotation to the left.
- A view with 45° rotation to the right.
- Left lateral view with arms up.
- Right lateral view with arms up.
Pre-operative mammography:
- To exclude pre-operative tumors, cysts, and fat necrosis.
- To assess pre-operative breast volume.
- To be compared to post-operative mammography.
Surgical technique:
- Pinch test of excess tissue in the lateral chest wall (donor flap).
- Mapping of the perforators by hand-held Doppler probe.
- Mastopexy and auto-augmentation (as described by Rubin JP, Khachi G. Mastopexy After Massive Weight Loss: Dermal Suspension and Selective Auto-Augmentation. Clinics in Plastic Surgery. 2008;35(1), 123-129.), which includes Wise Pattern with preservation of inferior and central pedicle, in addition to lateral extension to encompass the lateral chest wall skin roll.
- Intraoperative perforator marking (thoracodorsal artery perforator versus intercostal artery perforator).
- Flap transposition and anchoring to the chest wall by permanent sutures to the periosteum of the second rib for auto-augmentation and filling of the upper pole.
- Skin closure and surgical drains in the breast and donor site.
- Wound dressing and surgical bra.
- Post-operative follow-up: The patient was evaluated:
- During the first 48 hours: for hematoma, NAC compromise and drain removal according to amount and color (less than 50 cc/ serous) and then discharged.
- At postoperative day 7, 10, 14 and 21: to detect any complications such as seroma, wound dehiscence, infection (redness, hotness, tenderness, discharge).
Patient evaluation: Final results were documented at 6 and 12 months through:
- Direct breast anthropometry: To compare to pre-operative measurements, as well as assess the sustainability of the post-operative results.
- Mammography:
- To measure breast volume.
- For signs of fat necrosis (as described by Chala LF, de Barros N, de Camargo Moraes P, Endo E, Kim SJ, Pincerato KM, Carvalho FM, Cerri GG. Fat Necrosis of the Breast: Mammographic, Sonographic, Computed Tomography, and Magnetic Resonance Imaging Findings. Curr Probl Diagn Radiol. 2004;33(3):106-26.), which reflect partial or total flap loss: Oil cyst (radiolucent mass surrounded by a thin fibrous membrane). Fibrotic reaction (irregular spiculated density). Calcifications (thin-walled calcifications in oil cysts or coarse irregular calcifications with radiolucent areas interspersed between them).
- Photographic assessment (as before):
The pre and post-operative photos were analyzed by three plastic surgery consultants who were not involved in the study, through a PowerPoint presentation. Data provided by surgeons were grouped under three categories: poor, good or excellent. The inter-observer concordance rate was statistically calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients were subjected to the same intervention.
| Arm | Type | Receives |
|---|---|---|
| Surgery | Other | Procedure: Breast auto-augmentationSurgical intervention for breast reshaping utilizing chest wall perforators for auto-augmentation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age: 18-45 years old.
- Weight:
- BMI: 18.5 - 30 kg/m2.
- Ptotic and deflated breasts with Pittsburgh Rating Scale (PRS) score 2-3 (Song, et al., 2005).
- Patients seeking autologous augmentation or refusing implants.
Key exclusion criteria (10 listed)
- Weight fluctuations in the previous 6 months.
- Medical co-morbidities (e.g., uncontrolled diabetes, uncontrolled hypertension, thyroid diseases, hormonal disturbances, cardiopulmonary diseases).
- Hereditary conditions that affect wound healing (e.g., Ehler Danlos Syndrome, Progeria).
- Active smokers (Smokers are required to stop smoking 1 month before surgery).
- Nutritional deficiencies (e.g., iron, vitamin B12, protein, folate).
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 |
|---|---|---|
| Breast auto-augmentationSingle group assignment. All patients included were subjected to utilizing chest wall perforator flaps for breast reshaping. | Procedure or surgery | Surgery |
Primary outcome
Measurement of breast volume by sono-mammography
Time frame: One year follow-up
Use of sono-mammography to measure the breast volume in cubic centimetres preoperatively, after 6 months and after one year following surgery. The equation used to measure the breast volume was as follows: Breast volume = π/4 × (W × H × C) where W = breast width, H = breast height, and C=compression thickness in craniocaudal mammography)
3 secondary outcomes
Sternal notch to nipple distance
Time frame: One-year follow-up
Nipple to inframammary fold distance
Time frame: One-year follow-up
Measure of nipple-to-nipple distance
Time frame: One-year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Breast Ptosis
RecruitingObservational study
Autologous Free Dermal Graft Support in Superior Pedicle Vertical Scar Reduction Mammaplasty
Breast Ptosis, Mammaplasty
Not yet recruiting
Hybrid Autologous Breast Augmentation in Mastopexy With Internal BRA Fixation; Using Local Breast Tissues and Fat Grafting
Breast Ptosis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
Amr AW Mabrouk, MD study director
Faculty of Medicine, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast auto-augmentation in people with Breast Ptosis, run by Ain Shams University 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 8 inclusion and 10 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: finished, as of the sponsor's last update on 26 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of breast volume by sono-mammography (time frame: One year follow-up). 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 26 Feb 2024.