A Randomized Study Evaluating the Efficacy of the Synthetic Adhesive Solution Ifabond, in Reducing Seroma Formation Post Surgery in Breast Cancer Patients, When Used in Partial Mastectomy With or Without Axillary Lymph Node Dissection
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:
1. Arm A: Applying Ifabond
2. Arm B: Without Ifabond
Patients will be stratified according to these two criteria:
1. Axillary Lymph Node Dissection planned (ALND)
2. 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
- 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
- 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Change in seroma formation
The volume of drain at Day 3 (or 7 in case of axillary lymph node dissection) post surgery will be documented, then patients will have an ultrasound exam at day 15 and day 30 (+or- 2 days) to measure seroma.
Day 3 (or 7 in case of axillary lymph node dissection), day15 and day 30 post surgery
Michel CONTE, MD
Hôpital Ambroise Paré, Marseille
France: ANSM (Agence nationale de sécurité du médicament et des produits de santé)
RCB ID: 2011-A01014-37