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

14 giugno 2026 aggiornato da: Murat Çelik, Cumhuriyet University Hospital

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

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

70

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Murat Çelik, Assistant Professor
  • Numero di telefono: +905546902104
  • Email: mucetr@gmail.com

Backup dei contatti dello studio

Luoghi di studio

    • Sivas
      • Sivas, Sivas, Turchia (Türkiye), 58050
        • Sivas Cumhuriyet University
        • Contatto:
        • Contatto:
          • Murat Çelik, Assistant Professor
          • Numero di telefono: 05546902104
          • Email: mucetr@gmail.com
        • Investigatore principale:
          • Murat Çelik, Assistant Professor
        • Sub-investigatore:
          • Handan Derebaşınlıoğlu, Associate Professor

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
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.
Altri nomi:
  • 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Nipple-to-Inframammary Fold Distance
Lasso di tempo: 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.
From postoperative month 1 to postoperative month 6

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Sternal Notch-to-Nipple Distance
Lasso di tempo: 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.
From postoperative month 1 to postoperative month 6
Change in Lower Pole Ratio
Lasso di tempo: 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.
From postoperative month 1 to postoperative month 6
Patient Satisfaction With Breasts
Lasso di tempo: 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.
Postoperative month 6
Blinded Photographic Aesthetic Assessment
Lasso di tempo: 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.
Preoperative period and postoperative month 6

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Breast Base Height-to-Width Ratio
Lasso di tempo: 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.
From postoperative month 1 to postoperative month 6

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Murat Çelik, Assistant Professor, Cumhuriyet University
  • Direttore dello studio: Handan Derebaşınlıoğlu, Cumhuriyet University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 febbraio 2028

Completamento dello studio (Stimato)

1 febbraio 2028

Date di iscrizione allo studio

Primo inviato

14 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 giugno 2026

Primo Inserito (Effettivo)

18 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano IPD

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.

Periodo di condivisione IPD

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.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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