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

NCT04904653 | Recruiting Phase 4

• 1 other identifier: HVST-HEMO-20
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemopatch; Breast Cancer; Axillary Lymphadenectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Hemopatch Group:

EXPERIMENTAL

Hemopatch + suction drainage

Device: Hemopatch

Control group

OTHER

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

Other: Control group

Interventions

Hemopatch DEVICE

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

Hemopatch Group:

Control group OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead
• Asociación De Cirujanos De Mama De Toledo: collaborator

Study Sites (1)

General Surgery and Digestive System Service

Toledo, 45004, Spain

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

María García Ávila, MD

CONTACT

638432910; garciaavilamaria@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 27, 2021
• Study Start: November 8, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)