The Effectiveness of Hemopatch® in the Reduction of Post-surgical Serous Drainage
NCT ID: NCT04904653
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
118 participants
INTERVENTIONAL
2021-11-08
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Hemopatch Group: Hemopatch (hemostatic device and surgical sealant) + suction drainage
* Control group: no sealant (liquid, gel or patch) + suction drain
OTHER
SINGLE
Study Groups
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Hemopatch Group:
Hemopatch + suction drainage
Hemopatch
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
Control group
No sealant (liquid, gel or patch) + suction drain
Control group
No sealant (liquid, gel or patch) + suction drain
Interventions
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Hemopatch
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
Control group
No sealant (liquid, gel or patch) + suction drain
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
FEMALE
No
Sponsors
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Asociación De Cirujanos De Mama De Toledo
OTHER
Instituto de Investigación Hospital Universitario La Paz
OTHER
Responsible Party
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Locations
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General Surgery and Digestive System Service
Toledo, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HVST-HEMO-20
Identifier Type: -
Identifier Source: org_study_id
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