Autologous Free Dermal Graft Support in Superior Pedicle Vertical Scar Reduction Mammaplasty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-65
SponsorCumhuriyet University Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Previous breast surgery
Oncoplastic breast reduction
Unilateral reduction mammaplasty
Use of a pedicle technique other than the superior pedicle
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Autologous Free Dermal Graft Support
Procedure/SurgeryPlacement 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Autologous Free Dermal Graft Group1 intervention
Group B: No Free Dermal Graft Group0 interventions
Trial outcomes
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.
Time frame
From postoperative month 1 to postoperative month 6Secondary outcomes
1
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.
Time frame
From postoperative month 1 to postoperative month 62
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.
Time frame
From postoperative month 1 to postoperative month 63
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.
Time frame
Postoperative month 64
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.
Time frame
Preoperative period and postoperative month 6Other outcomes
1
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.
Time frame
From postoperative month 1 to postoperative month 6Sponsors and contacts
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Source ClinicalTrials.gov