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

March 5, 2024 updated by: Instituto de Investigación Hospital Universitario La Paz

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

118

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Toledo, Spain, 45004
        • Recruiting
        • General Surgery and Digestive System Service
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hemopatch Group:
Hemopatch + suction drainage
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
Other: Control group
No sealant (liquid, gel or patch) + suction drain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total volume in milliliters (ml) of drainage
Time Frame: In the last 24 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Collaborators

Asociación De Cirujanos De Mama De Toledo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

May 24, 2021

First Posted (Actual)

May 27, 2021

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HVST-HEMO-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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