Overview
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.
Eligibility
INCLUSION CRITERIA
- Preoperative
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- Female gender
- Age ≥ 18 years
- Breast cancer N+
- Conservative Surgery: Lumpectomy or Quadrantectomy
- Berg levels 1-2 axillary lymphadenectomy
- Intraoperative
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- 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
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- Patients with ≥ 10 axillary nodes removed
EXCLUSION CRITERIA
- Preoperative
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- 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
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- 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).