This study is looking at the safety and effectiveness of OviTex PRS, a special material made from sheep tissue and polymer, in women having breast reconstruction. This material is used during implant-based breast reconstruction right after a mastectomy (surgery to remove a breast). To join, you must be a woman between 22 and 75 years old, planning your first immediate breast reconstruction with implants, and not currently smoke cigarettes. The study will measure how often reconstruction fails and how often major complications happen within 12 months after surgery. The current recruitment status is unclear, but the study plans to enroll 235 participants.

Study design

This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 235 women.

What's involved

Not specified in the trial record.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed from enrollment up to 12 months after their surgery to check for reconstructive failure and major complications.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.