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NCT Number: NCT07657962

Autologous Free Dermal Graft Support in Superior Pedicle Vertical Scar Reduction Mammaplasty

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

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Sivas Cumhuriyet University

Sivas, 58050, Turkey (Türkiye)

Location contact

Handan Derebaşınlıoğlu, Associate Professor

CONTACT

[email protected]

90 346 487 00 00

Handan Derebaşınlıoğlu, Associate Professor

SUB_INVESTIGATOR

Murat Çelik, Assistant Professor

CONTACT

[email protected]

05546902104

Murat Çelik, Assistant Professor

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous Free Dermal Graft Support

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Sternal Notch-to-Nipple Distance

    Time frame: From postoperative month 1 to postoperative month 6

    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.

  2. Change in Lower Pole Ratio

    Time frame: From postoperative month 1 to postoperative month 6

    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.

  3. Patient Satisfaction With Breasts

    Time frame: Postoperative month 6

    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.

  4. Blinded Photographic Aesthetic Assessment

    Time frame: Preoperative period and postoperative month 6

    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.

Other outcomes

  1. Change in Breast Base Height-to-Width Ratio

    Time frame: From postoperative month 1 to postoperative month 6

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Handan Derebaşınlıoğlu, Associate Professor

CONTACT

[email protected]

90 346 487 00 00

Murat Çelik, Assistant Professor

CONTACT

[email protected]

+905546902104

Sponsors and collaborators

Lead sponsor

Cumhuriyet University Hospital

Other

Registry information

Official study title

Effect of Autologous Free Dermal Graft Use on Lower Pole Stability in Superior Pedicle Vertical Scar Reduction Mammaplasty: A Prospective Comparative Cohort Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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