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

Primary Purpose

Hemopatch, Breast Cancer, Axillary Lymphadenectomy

Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Hemopatch
Control group
Sponsored by
Instituto de Investigación Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hemopatch

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • General Surgery and Digestive System ServiceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Hemopatch Group:

Control group

Arm Description

Hemopatch + suction drainage

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2021
Last Updated
May 19, 2022
Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Asociación De Cirujanos De Mama De Toledo
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1. Study Identification

Unique Protocol Identification Number
NCT04904653
Brief Title
The Effectiveness of Hemopatch® in the Reduction of Post-surgical Serous Drainage
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2021 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Asociación De Cirujanos De Mama De Toledo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemopatch, Breast Cancer, Axillary Lymphadenectomy

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
Participant
Allocation
Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hemopatch Group:
Arm Type
Experimental
Arm Description
Hemopatch + suction drainage
Arm Title
Control group
Arm Type
Other
Arm Description
No sealant (liquid, gel or patch) + suction drain
Intervention Type
Device
Intervention Name(s)
Hemopatch
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
No sealant (liquid, gel or patch) + suction drain
Primary Outcome Measure Information:
Title
Total volume in milliliters (ml) of drainage
Description
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.
Time Frame
In the last 24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
María García Ávila, MD
Phone
638432910
Email
garciaavilamaria@gmail.com
Facility Information:
Facility Name
General Surgery and Digestive System Service
City
Toledo
ZIP/Postal Code
45004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justo Álvarez Martín, MD
Email
justoam66@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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