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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hemopatch, Breast Cancer, Axillary Lymphadenectomy

Intervention / Treatment
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* Device: Hemopatch
* Other: Control group


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemopatch Group:<br>Hemopatch + suction drainage | Device: Hemopatch<br>* 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<br>|
| Other: Control group<br>No sealant (liquid, gel or patch) + suction drain | Other: Control group<br>* No sealant (liquid, gel or patch) + suction drain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total volume in milliliters (ml) of drainage | 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. | In the last 24 hours |