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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Eligibility

Primary outcome measure(s)

• Change in Nipple-to-Inframammary Fold Distance — 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.

Trial sites (1)

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