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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Mammaplasty; Breast Ptosis; Lower Pole Elongation; Postoperative Breast Pseudoptosis
• Intervention / Treatment: Procedure: Autologous Free Dermal Graft Support

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 Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Murat Çelik, Assistant Professor; Phone Number: +905546902104; Email: mucetr@gmail.com
• Study Contact Backup: Name: Handan Derebaşınlıoğlu, Associate Professor; Phone Number: 90 346 487 00 00; Email: handanderebasinlioglu@gmail.com

Study Locations

• Turkey (Türkiye)
  • Sivas
    • Sivas, Sivas, Turkey (Türkiye), 58050
      • Sivas Cumhuriyet University
      • Contact: Handan Derebaşınlıoğlu, Associate Professor; Phone Number: 90 346 487 00 00; Email: handanderebasinlioglu@gmail.com
      • Contact: Murat Çelik, Assistant Professor; Phone Number: 05546902104; Email: mucetr@gmail.com
      • Principal Investigator: Murat Çelik, Assistant Professor
      • Sub-Investigator: Handan Derebaşınlıoğlu, Associate Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Autologous Free Dermal Graft 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.; Other Names: Autologous dermal graft support; Free dermal graft lower pole 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Preoperative period and postoperative month 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Breast Base Height-to-Width Ratio	Breast base height-to-width ratio will be calculated by dividing breast base height by breast base width. Breast base height will be measured as the vertical distance between the superior breast border and the inframammary fold, and breast base width will be measured as the widest medial-to-lateral breast distance. The change in this ratio will be calculated between postoperative month 1 and postoperative month 6. Right and left breast ratios will be calculated separately, and the mean value of both breasts will be used for analysis.	From postoperative month 1 to postoperative month 6

Collaborators and Investigators

• Sponsor: Cumhuriyet University Hospital
• Investigators: Principal Investigator: Murat Çelik, Assistant Professor, Cumhuriyet University; Study Director: Handan Derebaşınlıoğlu, Cumhuriyet University

Publications and helpful links

General 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.
• Hudson 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.
• Bitik 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.
• Wagner 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.
• Choi 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.
• Singh 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: June 14, 2026
• First Submitted That Met QC Criteria: June 14, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 14, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Aesthetic outcome; Reduction mammaplasty; Superior pedicle; Autologous free dermal graft; Vertical scar reduction mammaplasty
• Other Study ID Numbers: 26_06_04_5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No