Hemopatch, Breast Cancer, Axillary Lymphadenectomy
Conditions
Brief 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.
Interventions
DEVICEHemopatch
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
OTHERControl group
No sealant (liquid, gel or patch) + suction drain
Sponsors
Asociación De Cirujanos De Mama De Toledo
Instituto de Investigación Hospital Universitario La Paz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention model description
After axillary node dissection, patients will be randomised to: * Hemopatch Group: Hemopatch (hemostatic device and surgical sealant) + suction drainage * Control group: no sealant (liquid, gel or patch) + suction drain
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total volume in milliliters (ml) of drainage | In the last 24 hours | Total volume in milliliters (ml) of drainage: To be measured in the hospital every day before discharge, and collected daily after discharge with a follow-up of phone calls or patient diaries during hospital visits until extraction drain. |
Countries
Spain
Contacts
Primary ContactMaría García Ávila, MD
Outcome results
None listed