Efficacy Study of Ifabond in Breast Cancer Surgery

Breast cancer patients will be selected at their preoperative visit with the surgeon, who will inform them about the study and answer their questions.

Patients who consent to participate will be randomized to one of two arms:

• Arm A: Applying Ifabond
• Arm B: Without Ifabond

Patients will be stratified according to these two criteria:

• Axillary Lymph Node Dissection planned (ALND)
• Body Mass Index (BMI)

The following parameters will be measured:

• ECOG status and Blood Pressure at day 3(day 7 in case of ALND), day 15 and day 30 post surgery
• Volume of drainage at day 3 and at (day 7 in case of ALND)post surgery
• Discomfort alleged by the patient at day 3(day 7 in case of ALND), day 15 and day 30 post surgery
• Lymphocele volume measured by ultrasound at day 15 and day 30 post surgery
• If the volume is ≥ 100cc, a needle aspiration will be performed, and the volume of aspirate will be documented.
• Adverse events and concomitant medications will be collected throughout the study until 30 days after the last ultrasound.

Inclusion criteria

• "Eastern Cooperative Oncology Group" ECOG status ≤ 2
• Diagnosis of invasive or In situ breast cancer
• Patient undergoing partial mastectomy with or without axillary lymph node dissection,(without communication between the two surgical loges)

Exclusion criteria

• Pregnant or breast-feeding patient
• Participation at another protocol with an Investigational drug (within the last 4 weeks before enrollment)
• Known hypersensitivity to Cyanoacrylate
• Known hypersensitivity to formaldehyde
• Patient who experience systemic infections preoperatively, or have conditions that are known to interfere with the healing process
• Patient with uncontrolled diabetes