Breast PtosisNCT07657962
Autologous Free Dermal Graft Support in Superior Pedicle Vertical Scar Reduction Mammaplasty
An observational study of Breast Ptosis and Mammaplasty, run by Cumhuriyet University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn whether using an autologous free dermal graft during breast reduction surgery helps maintain lower breast pole shape over time in women undergoing primary bilateral reduction mammaplasty. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Ptosis, Mammaplasty, Lower Pole Elongation
- What is being tested?
- Autologous Free Dermal Graft Support
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Aug 2026to 28 Feb 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of female patients aged 18 to 65 years who are scheduled to undergo primary bilateral reduction mammaplasty using the superior pedicle vertical scar technique at the Department of Plastic, Reconstructive and Aesthetic Surgery, Sivas Cumhuriyet University. Eligible patients will be evaluated consecutively during the recruitment period. Patients who meet the eligibility criteria and provide written informed consent for clinical measurements, standardized medical photography, and postoperative follow-up will be included.
Who may be able to join
- Female participants aged 18 to 65 years
- Planned primary bilateral reduction mammaplasty
- Planned use of the superior pedicle vertical scar technique
- Willingness to attend at least 6 months of postoperative follow-up
- Ability to provide written informed consent
- Consent for standardized medical photography and clinical breast measurements
Who cannot join
- Previous breast surgery
- Oncoplastic breast reduction
- Unilateral reduction mammaplasty
- Use of a pedicle technique other than the superior pedicle
- Use of a scar pattern other than the vertical scar pattern
- Presence of a systemic condition expected to significantly impair wound healing
- Active smoking within the last 6 weeks before surgery
- Incomplete 6-month follow-up data for the primary outcome analysis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sivas Cumhuriyet University
Sivas, Sivas, 58050
Murat Çelik, Assistant Professor, 05546902104, mucetr@gmail.com
Handan Derebaşınlıoğlu, Associate Professor, 90 346 487 00 00, handanderebasinlioglu@gmail.com
About this study
Official title: Effect of Autologous Free Dermal Graft Use on Lower Pole Stability in Superior Pedicle Vertical Scar Reduction Mammaplasty: A Prospective Comparative Cohort Study
The goal of this observational study is to learn whether using an autologous free dermal graft during breast reduction surgery helps maintain lower breast pole shape over time in women undergoing primary bilateral reduction mammaplasty.
The main question it aims to answer is:
Read more
Does autologous free dermal graft support reduce lower pole lengthening between 1 month and 6 months after surgery?
Researchers will compare two groups of participants. One group will undergo superior pedicle vertical scar reduction mammaplasty with autologous free dermal graft support as part of routine surgical care. The other group will undergo the same basic breast reduction technique without autologous free dermal graft support.
Participants will:
- Have their planned breast reduction surgery as part of routine care
- Attend postoperative follow-up visits at 1, 3, and 6 months
- Have standard breast measurements and medical photographs taken during follow-up
- Complete a breast satisfaction questionnaire at 6 months
Read the detailed description
Reduction mammaplasty is a well-established procedure performed for symptomatic breast hypertrophy and breast ptosis. In addition to volume reduction, the operation aims to achieve a durable breast shape, stable lower pole contour, and an appropriate nipple-areola complex position. However, even after technically successful surgery, postoperative breast morphology may change over time. Lower pole elongation, pseudoptosis, and bottoming-out remain relevant problems, particularly in patients with large resection volumes, poor tissue elasticity, or increased load on the lower pole.
Several internal support methods have been described to improve long-term shape stability after reduction mammaplasty. These include dermal suspension flaps, dermal bra techniques, parenchymal fixation sutures, and inframammary fold reinforcement. In the present study, we will evaluate an autologous support method in which de-epithelialized dermal tissue obtained during the operation is used as a free dermal graft and placed in the lower pole region. Unlike vascularized dermal flaps, this graft is not maintained on a vascular pedicle. This approach may provide a simple autologous support option without the need for synthetic or biological mesh material.
This study is planned as a prospective, single-center, observational, comparative cohort study. Participants undergoing primary bilateral superior pedicle vertical scar reduction mammaplasty will be followed with a standardized postoperative assessment protocol. The study will not include randomization or any study-related assignment to a surgical technique. The surgical approach will be determined according to the routine practice of the operating surgeon. In the same department, one routine approach includes autologous free dermal graft support in the lower pole, whereas the comparison approach uses the same basic superior pedicle vertical scar reduction mammaplasty technique without free dermal graft placement.
The planned enrollment is 70 participants. Sample size calculation was based on the expected between-group difference in postoperative lower pole change. A 1 cm difference was accepted as clinically meaningful, with an estimated standard deviation of 1.3 cm. Using G*Power 3.1, with a two-sided alpha level of 0.05, 80% power, an effect size of 0.77, and a 1:1 group ratio, at least 28 participants were required in each group. Considering possible loss to follow-up, the planned sample size was increased to 35 participants per group.
Demographic, clinical, operative, anthropometric, photographic, patient-reported, and postoperative safety data will be collected prospectively. Demographic and clinical variables will include age, body mass index, smoking history, comorbidities, pregnancy and breastfeeding history, and preoperative breast characteristics. Operative variables will include surgical group, resection weights, operative time, drain use, and routine perioperative data. Postoperative follow-up data will include serial breast measurements, standardized photographs, patient-reported satisfaction, complications, and clinically relevant postoperative events.
Anthropometric measurements will be obtained according to a standardized protocol. Measurements will be performed with the participant standing in a natural posture and with the arms relaxed. Right and left breast measurements will be recorded separately. For bilateral continuous breast measurements, the mean value of both breasts will be used for participant-level analysis. Standardized medical photographs will be obtained in predefined views and assessed by independent evaluators blinded to the surgical group.
Eligible participants will be evaluated consecutively during the recruitment period. Data will be recorded on predefined case report forms. Before analysis, range and consistency checks will be performed. When necessary, source data will be verified using clinical records. Missing data will be reviewed before final analysis. Participants without the required follow-up measurement for the primary analysis will not be included in the primary endpoint analysis, and the extent of missing data will be reported.
The statistical analysis will compare the two routine surgical approaches. Potential confounding factors, including baseline patient characteristics and operative variables, will be considered during analysis. The study is expected to provide prospective clinical data on the possible role of autologous free dermal graft support in maintaining lower pole stability after superior pedicle vertical scar reduction mammaplasty.
- Being tested
- Autologous Free Dermal Graft Support
- Keywords
- Reduction mammaplasty, Superior pedicle, Autologous free dermal graft, Vertical scar reduction mammaplasty, Aesthetic outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Free Dermal Graft SupportProcedure or surgery
Also called Autologous dermal graft support, Free dermal graft lower pole support
Placement of a de-epithelialized autologous free dermal graft in the lower pole region during superior pedicle vertical scar reduction mammaplasty. The dermal graft is obtained from the participant's own de-epithelialized skin during the planned breast reduction procedure and is used as an autologous structural support method. The graft is not vascularized and does not remain attached to a dermal or glandular pedicle. No synthetic or biological mesh material is used.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Free Dermal Graft Group | Participants undergoing primary bilateral superior pedicle vertical scar reduction mammaplasty with placement of a de-epithelialized autologous free dermal graft in the lower pole region as part of routine surgical practice. No study-specific surgical assignment or randomization will be performed. Receives: Procedure: Autologous Free Dermal Graft Support | |
| No Free Dermal Graft Group | Participants undergoing primary bilateral superior pedicle vertical scar reduction mammaplasty without placement of an autologous free dermal graft. This group will receive the same basic reduction mammaplasty technique according to routine surgical practice, without study-specific surgical assignment or randomization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nipple-to-Inframammary Fold Distance
Change in nipple-to-inframammary fold distance will be calculated as the difference between the postoperative month 6 and postoperative month 1 measurements. Measurements will be recorded in centimeters. A positive value will indicate lower pole elongation. Right and left breast measurements will be recorded separately, and the mean value of both breasts will be used for analysis.
Measured: From postoperative month 1 to postoperative month 6
Secondary outcomes (4)
Change in Sternal Notch-to-Nipple Distance
Change in sternal notch-to-nipple distance will be calculated as the difference between the postoperative month 6 and postoperative month 1 measurements. Measurements will be recorded in centimeters. A positive value will indicate inferior displacement of the nipple-areola complex. Right and left breast measurements will be recorded separately, and the mean value of both breasts will be used for analysis.
Measured: From postoperative month 1 to postoperative month 6
Change in Lower Pole Ratio
The lower pole ratio will be calculated by dividing the nipple-to-inframammary fold distance by the sternal notch-to-nipple distance. The change in lower pole ratio will be calculated as the difference between the postoperative month 6 and postoperative month 1 values. Right and left breast ratios will be calculated separately, and the mean value of both breasts will be used for analysis.
Measured: From postoperative month 1 to postoperative month 6
Patient Satisfaction With Breasts
Patient-reported satisfaction with breast appearance will be assessed at postoperative month 6 using the Satisfaction with Breasts scale of the BREAST-Q Reduction/Mastopexy module. The total scale score will be used for analysis.
Measured: Postoperative month 6
Blinded Photographic Aesthetic Assessment
Standardized preoperative and postoperative month 6 photographs will be evaluated by independent assessors blinded to surgical group. Overall aesthetic change will be assessed using the Global Aesthetic Improvement Scale. If more than one assessor evaluates the photographs, the mean assessor score will be used for analysis.
Measured: Preoperative period and postoperative month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start24 Aug 2026
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Çelik, Cumhuriyet University Hospital
- Investigators
- Handan Derebaşınlıoğlu, Study director, Cumhuriyet UniversityMurat Çelik, Assistant Professor, Principal investigator, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657962
- Sponsor's protocol ID
- 26_06_04_5
- Status last verified
- Aug 2026
- First submitted
- 14 Jun 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the main results of the study may be shared upon reasonable request. Shared data may include demographic variables, surgical group, anthropometric breast measurements, patient-reported outcome scores, blinded photographic assessment scores, and selected perioperative variables. Identifiable data, medical photographs, and any information that may allow participant identification will not be shared.
Publications
Qiao Q, Sun J, Liu C, Liu Z, Zhao R. Reduction mammaplasty and correction of ptosis: dermal bra technique. Plast Reconstr Surg. 2003 Mar;111(3):1122-30. doi: 10.1097/01.PRS.0000046806.64384.60.
PubMed 12621182Hudson DA, Moodley S. Breast Reduction: Decreasing Complications and Improving Long-Term Aesthetic Results with Parenchymal Sutures. Plast Reconstr Surg Glob Open. 2017 Sep 19;5(9):e1470. doi: 10.1097/GOX.0000000000001470. eCollection 2017 Sep.
PubMed 29062642Bitik O, Uzun H. Analysis of Lower Breast Pole Length and Nipple-Areola Complex Position Following Superior Pedicle, Short Horizontal Scar Breast Reduction. Aesthetic Plast Surg. 2016 Oct;40(5):690-8. doi: 10.1007/s00266-016-0663-4. Epub 2016 Jun 29.
PubMed 27357632Wagner RD, Lisiecki JL, Chiodo MV, Rohrich RJ. Longevity of ptosis correction in mastopexy and reduction mammaplasty: A systematic review of techniques. JPRAS Open. 2022 May 13;34:1-9. doi: 10.1016/j.jpra.2022.05.003. eCollection 2022 Dec.
PubMed 36061406Choi M, Unger J, Small K, Tepper O, Kumar N, Feldman D, Karp N. Defining the kinetics of breast pseudoptosis after reduction mammaplasty. Ann Plast Surg. 2009 May;62(5):518-22. doi: 10.1097/SAP.0b013e31819fb00c.
PubMed 19387153Singh KA, Losken A. Additional benefits of reduction mammaplasty: a systematic review of the literature. Plast Reconstr Surg. 2012 Mar;129(3):562-570. doi: 10.1097/PRS.0b013e31824129ee.
PubMed 22090252
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Autologous Free Dermal Graft Use on Lower Pole Stability in Superior Pedicle Vertical Scar Reduction Mammaplasty: A Prospective Comparative Cohort Study
- ClinicalTrials.gov ID
- NCT07657962
- Acronym / sponsor ID
- 26_06_04_5
- Keywords
- Reduction mammaplasty, Superior pedicle, Autologous free dermal graft, Vertical scar reduction mammaplasty, Aesthetic outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cumhuriyet University HospitalUniversity, hospital or other
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 18 Jun 2026 (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.
The goal of this observational study is to learn whether using an autologous free dermal graft during breast reduction surgery helps maintain lower breast pole shape over time in women undergoing primary bilateral reduction mammaplasty.
The main question it aims to answer is:
Does autologous free dermal graft support reduce lower pole lengthening between 1 month and 6 months after surgery?
Researchers will compare two groups of participants. One group will undergo superior pedicle vertical scar reduction mammaplasty with autologous free dermal graft support as part of routine surgical care. The other group will undergo the same basic breast reduction technique without autologous free dermal graft support.
Participants will:
- Have their planned breast reduction surgery as part of routine care
- Attend postoperative follow-up visits at 1, 3, and 6 months
- Have standard breast measurements and medical photographs taken during follow-up
- Complete a breast satisfaction questionnaire at 6 months
Detailed description
Reduction mammaplasty is a well-established procedure performed for symptomatic breast hypertrophy and breast ptosis. In addition to volume reduction, the operation aims to achieve a durable breast shape, stable lower pole contour, and an appropriate nipple-areola complex position. However, even after technically successful surgery, postoperative breast morphology may change over time. Lower pole elongation, pseudoptosis, and bottoming-out remain relevant problems, particularly in patients with large resection volumes, poor tissue elasticity, or increased load on the lower pole.
Several internal support methods have been described to improve long-term shape stability after reduction mammaplasty. These include dermal suspension flaps, dermal bra techniques, parenchymal fixation sutures, and inframammary fold reinforcement. In the present study, we will evaluate an autologous support method in which de-epithelialized dermal tissue obtained during the operation is used as a free dermal graft and placed in the lower pole region. Unlike vascularized dermal flaps, this graft is not maintained on a vascular pedicle. This approach may provide a simple autologous support option without the need for synthetic or biological mesh material.
This study is planned as a prospective, single-center, observational, comparative cohort study. Participants undergoing primary bilateral superior pedicle vertical scar reduction mammaplasty will be followed with a standardized postoperative assessment protocol. The study will not include randomization or any study-related assignment to a surgical technique. The surgical approach will be determined according to the routine practice of the operating surgeon. In the same department, one routine approach includes autologous free dermal graft support in the lower pole, whereas the comparison approach uses the same basic superior pedicle vertical scar reduction mammaplasty technique without free dermal graft placement.
The planned enrollment is 70 participants. Sample size calculation was based on the expected between-group difference in postoperative lower pole change. A 1 cm difference was accepted as clinically meaningful, with an estimated standard deviation of 1.3 cm. Using G*Power 3.1, with a two-sided alpha level of 0.05, 80% power, an effect size of 0.77, and a 1:1 group ratio, at least 28 participants were required in each group. Considering possible loss to follow-up, the planned sample size was increased to 35 participants per group.
Demographic, clinical, operative, anthropometric, photographic, patient-reported, and postoperative safety data will be collected prospectively. Demographic and clinical variables will include age, body mass index, smoking history, comorbidities, pregnancy and breastfeeding history, and preoperative breast characteristics. Operative variables will include surgical group, resection weights, operative time, drain use, and routine perioperative data. Postoperative follow-up data will include serial breast measurements, standardized photographs, patient-reported satisfaction, complications, and clinically relevant postoperative events.
Anthropometric measurements will be obtained according to a standardized protocol. Measurements will be performed with the participant standing in a natural posture and with the arms relaxed. Right and left breast measurements will be recorded separately. For bilateral continuous breast measurements, the mean value of both breasts will be used for participant-level analysis. Standardized medical photographs will be obtained in predefined views and assessed by independent evaluators blinded to the surgical group.
Eligible participants will be evaluated consecutively during the recruitment period. Data will be recorded on predefined case report forms. Before analysis, range and consistency checks will be performed. When necessary, source data will be verified using clinical records. Missing data will be reviewed before final analysis. Participants without the required follow-up measurement for the primary analysis will not be included in the primary endpoint analysis, and the extent of missing data will be reported.
The statistical analysis will compare the two routine surgical approaches. Potential confounding factors, including baseline patient characteristics and operative variables, will be considered during analysis. The study is expected to provide prospective clinical data on the possible role of autologous free dermal graft support in maintaining lower pole stability after superior pedicle vertical scar reduction mammaplasty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Free Dermal Graft Group | – | Procedure: Autologous Free Dermal Graft SupportParticipants undergoing primary bilateral superior pedicle vertical scar reduction mammaplasty with placement of a de-epithelialized autologous free dermal graft in the lower pole region as part of routine surgical practice. No study-specific surgical assignment or randomization will be performed. |
| No Free Dermal Graft Group | – | –Participants undergoing primary bilateral superior pedicle vertical scar reduction mammaplasty without placement of an autologous free dermal graft. This group will receive the same basic reduction mammaplasty technique according to routine surgical practice, without study-specific surgical assignment or randomization. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of female patients aged 18 to 65 years who are scheduled to undergo primary bilateral reduction mammaplasty using the superior pedicle vertical scar technique at the Department of Plastic, Reconstructive and Aesthetic Surgery, Sivas Cumhuriyet University. Eligible patients will be evaluated consecutively during the recruitment period. Patients who meet the eligibility criteria and provide written informed consent for clinical measurements, standardized medical photography, and postoperative follow-up will be included.
Key inclusion criteria (6 listed)
- Female participants aged 18 to 65 years
- Planned primary bilateral reduction mammaplasty
- Planned use of the superior pedicle vertical scar technique
- Willingness to attend at least 6 months of postoperative follow-up
- Ability to provide written informed consent
Key exclusion criteria (8 listed)
- Previous breast surgery
- Oncoplastic breast reduction
- Unilateral reduction mammaplasty
- Use of a pedicle technique other than the superior pedicle
- Use of a scar pattern other than the vertical scar pattern
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 |
|---|---|---|
| Autologous Free Dermal Graft SupportAlso: Autologous dermal graft support, Free dermal graft lower pole supportPlacement of a de-epithelialized autologous free dermal graft in the lower pole region during superior pedicle vertical scar reduction mammaplasty. The dermal graft is obtained from the participant's own de-epithelialized skin during the planned breast reduction procedure and is used as an autologous structural support method. The graft is not vascularized and does not remain attached to a dermal or glandular pedicle. No synthetic or biological mesh material is used. | Procedure or surgery | Autologous Free Dermal Graft Group |
Primary outcome
Change in Nipple-to-Inframammary Fold Distance
Time frame: From postoperative month 1 to postoperative month 6
Change in nipple-to-inframammary fold distance will be calculated as the difference between the postoperative month 6 and postoperative month 1 measurements. Measurements will be recorded in centimeters. A positive value will indicate lower pole elongation. Right and left breast measurements will be recorded separately, and the mean value of both breasts will be used for analysis.
4 secondary outcomes
Change in Sternal Notch-to-Nipple Distance
Time frame: From postoperative month 1 to postoperative month 6
Change in Lower Pole Ratio
Time frame: From postoperative month 1 to postoperative month 6
Patient Satisfaction With Breasts
Time frame: Postoperative month 6
Blinded Photographic Aesthetic Assessment
Time frame: Preoperative period and postoperative month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Background: PubMed 12621182Qiao Q, Sun J, Liu C, Liu Z, Zhao R. Reduction mammaplasty and correction of ptosis: dermal bra technique. Plast Reconstr Surg. 2003 Mar;111(3):1122-30. doi: 10.1097/01.PRS.0000046806.64384.60.
- Background: PubMed 29062642Hudson DA, Moodley S. Breast Reduction: Decreasing Complications and Improving Long-Term Aesthetic Results with Parenchymal Sutures. Plast Reconstr Surg Glob Open. 2017 Sep 19;5(9):e1470. doi: 10.1097/GOX.0000000000001470. eCollection 2017 Sep.
- Background: PubMed 27357632Bitik O, Uzun H. Analysis of Lower Breast Pole Length and Nipple-Areola Complex Position Following Superior Pedicle, Short Horizontal Scar Breast Reduction. Aesthetic Plast Surg. 2016 Oct;40(5):690-8. doi: 10.1007/s00266-016-0663-4. Epub 2016 Jun 29.
- Background: PubMed 36061406Wagner RD, Lisiecki JL, Chiodo MV, Rohrich RJ. Longevity of ptosis correction in mastopexy and reduction mammaplasty: A systematic review of techniques. JPRAS Open. 2022 May 13;34:1-9. doi: 10.1016/j.jpra.2022.05.003. eCollection 2022 Dec.
- Background: PubMed 19387153Choi M, Unger J, Small K, Tepper O, Kumar N, Feldman D, Karp N. Defining the kinetics of breast pseudoptosis after reduction mammaplasty. Ann Plast Surg. 2009 May;62(5):518-22. doi: 10.1097/SAP.0b013e31819fb00c.
- Background: PubMed 22090252Singh KA, Losken A. Additional benefits of reduction mammaplasty: a systematic review of the literature. Plast Reconstr Surg. 2012 Mar;129(3):562-570. doi: 10.1097/PRS.0b013e31824129ee.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the main results of the study may be shared upon reasonable request. Shared data may include demographic variables, surgical group, anthropometric breast measurements, patient-reported outcome scores, blinded photographic assessment scores, and selected perioperative variables. Identifiable data, medical photographs, and any information that may allow participant identification will not be shared.
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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.
Handan Derebaşınlıoğlu study director
Cumhuriyet University
Murat Çelik, Assistant Professor principal investigator
Cumhuriyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Ptosis and Mammaplasty, run by Cumhuriyet University Hospital at 1 site in Turkey (Türkiye).
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 25 Aug 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Murat Çelik, Assistant Professor (+905546902104, mucetr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nipple-to-Inframammary Fold Distance (time frame: From postoperative month 1 to postoperative month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07657962, which also lists 6 linked publications.
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 25 Aug 2026.