Autologous Free Dermal Graft Support in Superior Pedicle Vertical Scar Reduction Mammaplasty
Effect of Autologous Free Dermal Graft Use on Lower Pole Stability in Superior Pedicle Vertical Scar Reduction Mammaplasty: A Prospective Comparative Cohort Study
1 other identifier
observational
70
1 country
1
Brief 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. 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
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for all trials
Started Aug 2026
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2026
CompletedFirst Posted
Study publicly available on registry
June 18, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
June 18, 2026
June 1, 2026
1.5 years
June 14, 2026
June 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From postoperative month 1 to postoperative month 6
Secondary Outcomes (4)
Change in Sternal Notch-to-Nipple Distance
From postoperative month 1 to postoperative month 6
Change in Lower Pole Ratio
From postoperative month 1 to postoperative month 6
Patient Satisfaction With Breasts
Postoperative month 6
Blinded Photographic Aesthetic Assessment
Preoperative period and postoperative month 6
Other Outcomes (1)
Change in Breast Base Height-to-Width Ratio
From postoperative month 1 to postoperative month 6
Study Arms (2)
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.
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sivas Cumhuriyet University
Sivas, Sivas, 58050, Turkey (Türkiye)
Related Publications (6)
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.
PMID: 12621182BACKGROUNDHudson 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.
PMID: 29062642BACKGROUNDBitik 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.
PMID: 27357632BACKGROUNDWagner 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.
PMID: 36061406BACKGROUNDChoi 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.
PMID: 19387153BACKGROUNDSingh 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.
PMID: 22090252BACKGROUND
Study Officials
- STUDY DIRECTOR
Handan Derebaşınlıoğlu
Cumhuriyet University
- PRINCIPAL INVESTIGATOR
Murat Çelik, Assistant Professor
Cumhuriyet University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 14, 2026
First Posted
June 18, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
February 1, 2028
Last Updated
June 18, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- De-identified individual participant data and supporting information will be available beginning 6 months after publication of the main study results and for 5 years thereafter.
- Access Criteria
- De-identified individual participant data and supporting documents will be made available through the Sivas Cumhuriyet University AVESIS Scientific Data Sharing Module, if controlled access or embargoed access is available. If repository-based controlled access is not available, data will be shared by the corresponding investigator upon reasonable request after approval by the relevant institutional authority and completion of a data use agreement. Identifiable data, medical photographs, exact dates, hospital identifiers, and any information that may allow participant identification will not be shared.
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.