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

Instituto de Investigación Hospital Universitario La Paz

Status and phase: Enrolling; Phase 4

Conditions: Axillary Lymphadenectomy; Breast Cancer; Hemopatch

Treatments: Other: Control group; Device: Hemopatch

Study type: Interventional

Funder types: Other

Identifiers

NCT04904653

HVST-HEMO-20

Details and patient eligibility

About

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.

Enrollment: 118 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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118 participants in 2 patient groups

Hemopatch Group:

Experimental group

Description:

Hemopatch + suction drainage

Treatment:

Device: Hemopatch

Control group

Other group

Description:

No sealant (liquid, gel or patch) + suction drain

Treatment:

Other: Control group