Autologous Free Dermal Graft Support in Superior Pedicle Vertical Scar Reduction Mammaplasty (NCT07657962) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Autologous Free Dermal Graft Support in Superior Pedicle Vertical Scar Reduction Mammaplasty
Turkey (Türkiye)70 participantsStarted 2026-08-01
Plain-language 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
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Nipple-to-Inframammary Fold Distance
Timeframe: From postoperative month 1 to postoperative month 6