The Effectiveness of Hemopatch® in the Reduction of Post-surgical Serous Drainage
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
Instituto de Investigación Hospital Universitario La Paz
118 participants
Nov 8, 2021
INTERVENTIONAL
Conditions
Summary
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 Criteria12
- 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 Criteria15
- 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).
Interventions
HEMOPATCH Sealing Hemostat ("HEMOPATCH") consists of a soft, thin, pliable, flexible pad of collagen derived from bovine dermis, coated with NHS-PEG (pentaerythritol polyethylene glycol ether tetra-succinimidyl glutarate). Due to its flexible structure, the application of HEMOPATCH to the site where hemostasis / sealing is desired is easily controlled. For differentiation, the non-coated side is marked with blue squares using a biocompatible colorant. HEMOPATCH is supplied in the following 3 sizes: * HEMOPATCH 27 x 27 mm * HEMOPATCH 45 x 45 mm * HEMOPATCH 45 x 90 mm
No sealant (liquid, gel or patch) + suction drain
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04904653