The Effectiveness of Hemopatch® in the Reduction of Post-surgical Serous Drainage

INCLUSION CRITERIA

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

EXCLUSION CRITERIA

Preoperative:

• Mastectomy

• Previous radiation therapy

• Previous axillary emptying

• Liver pathology

• Diabetic decompensation: defined as any episode that has required medical attention in an emergency service or hospital admission; and also that which has required a modification of the patient's drugs, or an increase of more than 20% of the total daily dose.

• Known allergies to any component of Hemopatch (proteins of bovine origin or PEG)

• Psychiatric disorder that conditions the non-understanding of the questionnaire, or incapacitation of the patient to understand it

• Simultaneous participation in another clinical study

• PCR positive for SARS-CoV-2

Intraoperative:

• Level 3 axillary dissection (severe axillary involvement)

• Unexpected surgical contraindication

• Hemostasis and lymphostasis: ultrasonic techniques or other advanced energy techniques are excluded.

• Use of fibrin sealants (eg: Tisseel, Artiss, Tachosil), cyanoacrylate type adhesives (eg: Glubran-2) or other types of products (oxidized cellulose format, powders or gelatin sheets or collagen).