Status:
RECRUITING
The Effectiveness of Hemopatch® in the Reduction of Post-surgical Serous Drainage
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Collaborating Sponsors:
Asociación De Cirujanos De Mama De Toledo
Conditions:
Hemopatch
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 propos...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
November 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT04904653
Start Date
November 8 2021
End Date
December 1 2024
Last Update
March 6 2024
Active Locations (1)
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1
General Surgery and Digestive System Service
Toledo, Spain, 45004