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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04904653
• Other study ID #: HVST-HEMO-20
• Status: Recruiting
• Phase: Phase 4
• Start date: November 8, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: María García Ávila, MD
• Phone: 638432910
• Email: garciaavilamaria[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• 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

Other:
• Control group
No sealant (liquid, gel or patch) + suction drain

Locations

Country	Name	City	State
Spain	General Surgery and Digestive System Service	Toledo

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz	Asociación De Cirujanos De Mama De Toledo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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