Randomized Controlled and Single Blind Clinical Trial in Women With Breast Cancer and Axillary Lymphadenectomy, to Evaluate the Effectiveness of Hemopatch® in the Reduction of Post-surgical Serous Drainage
Hemopatch is an alternative to reduce morbidity associated with axillary lymphadenectomy surgery, possibly contributing to improved patient management, clinical outcomes, and hospital costs. We propose a multicenter, controlled, and randomized trial to study the efficacy of Hemopatch in reducing serous wound drainage.
⁃ Preoperative:
• Female gender
• Age ≥ 18 years
• Breast cancer N+
• Conservative Surgery: Lumpectomy or Quadrantectomy
• Berg levels 1-2 axillary lymphadenectomy
⁃ Intraoperative:
• Axillary incision separated from the incision for the breast lesion
• Placement of a closed low pressure suction drain in the axillary fossa
• Hemostasis and lymphostasis using clips, electrocautery, electric scalpel or bipolar coagulation
⁃ Postoperative:
⁃ \- Patients with ≥ 10 axillary nodes removed