Evaluation of the Efficacy and Safety of Using Platelet-rich Fibrin (PRF)-Based Lipobolus for the Immediate Reconstruction of Defects After Breast-conserving Resection for Breast Cancer (Minimally Invasive Primary Immediate Grafting)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-69
SponsorThe Leningrad Regional Clinical Hospital

About this trial

The goal of this clinical trial is to learn if a special type of fat graft, made by mixing a person's own fat with platelet-rich fibrin (PRF), works to fix breast shape defects after cancer surgery. PRF is a substance made from a person's own blood that is rich in growth factors, which may help the graft survive better.

The main questions it aims to answer are:

What percentage of the fat graft's volume remains in place 3 months after radiation therapy?

What is the safety of this procedure, including its side effects and any impact on cancer returning?

Participants will:

* Undergo standard breast-conserving surgery to remove the tumor * Have liposuction (fat removal) from their own belly or thighs * Receive a "lipobolus" (their own fat mixed with PRF) placed into the breast defect during the same surgery * Follow up for 12 months with ultrasound scans, physical exams, and questionnaires (BREASTQ) about their satisfaction and quality of life

Eligibility criteria

Qualifiers

Histologically verified breast cancer (BC).

Disease stage from cTis to cT2 according to the TNM classification (AJCC, 8th edition).

Tumor grade G1 or G2.

Estrogen receptor positivity (ER+).

Disqualifiers

Male gender.

ECOG ≥ 1.

Multifocal or multicentric tumor.

Grade G3.

Trial design

Treatments tested in this trial

  • Lipobolus (Autologous Fat + Platelet-Rich Fibrin+Calcium chloride)

Treatment groups

30 Participants
are divided into 1 treatment group