Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy (REDHEMOPACH)

February 16, 2023 updated by: Elvira Buch, Fundación para la Investigación del Hospital Clínico de Valencia

Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy: Randomized, Controlled, Multicenter Clinical Study

Aspirative drainage continues to be the "gold standard" for the management of this post-surgical complication, even though it can lead to complications such as obstruction of the drainage, peritubal leakage of the seroma, etc. This may result in pain and reduction in mobility of the affected arm.

Based on our positive clinical outcomes and the fact that there is not any published data available in the literature regarding this use of the patch, the investigators propose a multicentric, randomized controlled clinical trial, with the objective of comparing the Hemopatch® with the usual technique used (aspirative drainage) in terms of efficacy and safety.

Hypothesis: Placing a Hemopatch ® instead of an aspirative drainage in women after undergoing axillary lymph node dissection during breast cancer surgery may reduce the appearance of seroma and consequently the need for a puncture, as well as the complications related to aspirative drainage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Introduction:

    In the surgical management of breast cancer, a conservative approach is the "gold standard" for the mammary region. For the axillary region, however, this depends on the results of the sentinel lymph node biopsy (SLNB) with axillary lymph node dissection (ALND) continuing to be an indispensable procedure when the disease reaches this level.

    The complications that arise from this procedure can be divided in two groups: 1) early: seromas and nerve lesions and 2) late: lymphedema, functional disorders in shoulder movement and post-mastectomy pain syndrome.

    Seromas are the most frequent complications after an ALND. In themselves, they do not carry a high risk of morbidity. However, they delay healing of the surgical wound, increasing the risk of infection and number of ambulatory visits and furthermore, resulting in a deferral in the start of adjuvant therapies such as radio and chemotherapy.

    Aspirative drainage continues to be the "gold standard" for the management of this post-surgical complication, even though it can lead to complications such as obstruction of the drainage, peritubal leakage of the seroma, etc. This may result in pain and reduction in mobility of the affected arm.

    Hemopatch® is a hemosthatic sealer made from reabsorbable collagen. It comes in the from of patch, with CE marking that is already being used in the clinical setting in Spain and the rest of Europe.

    Taking into account the factors that reduce seroma formation after ALND and the characteristics of the patch, its application after surgery could be useful in preventing seroma formation. More specifically, the patch has proven to act as a

    • Hemosthatic, improving the first phase of inflammation
    • Adhesive, reducing the dead space left after ALND
    • Sealer, decreasing the exudate
  2. Rationale Based on this premise and in the context of a clinical protocol after the introduction of the patch in daily clinical practice, it was used on 28 patients that underwent ALND, obtaining favourable clinical results. This is a multicentric, randomized controlled clinical trial, with the objective of comparing the Hemopatch® with the usual technique used (aspirative drainage) in terms of efficacy and safety.
  3. Hypothesis Placing a Hemopatch ® instead of an aspirative drainage in women after undergoing ALND during breast cancer surgery may reduce the appearance of seroma and consequently the need for a puncture, as well as the complications related to aspirative drainage.

Study Type

Interventional

Enrollment (Actual)

228

Phase

  • Not Applicable

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

  • Name: Elvira Buch Villa, PhD MD
  • Phone Number: +34616800197
  • Email: buch_elv@gva.es

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Diagnosis of breast cancer,
  • scheduled for surgical treatment including conservative surgery and ALND.
  • Signed informed consent for ALND.

Exclusion Criteria:

  • Selective sentinel node biopsy negative.
  • Subsidiary mastectomy patients.
  • Denial of informed consent for axillary lymphadenectomy.

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
Other: aspirative drainage
Drainage is the usual treatment after axillary lymphadenectoma for breast cancer
Procedure: Aspirative drainage
The patient will be randomized after performing the lymphadenectomy, according to a table of random numbers performed in excel kuytools, then a compression bandage will be performed on all the patients and it will be controlled 24 hours postoperatively, the subsequent control will be weekly until the drain is removed. and / or the disappearance of the seroma
Active Comparator: Hemopatch
The hemopatch group will be the group without drainage and with a product patch
Device: hemopatch
The patient will be randomized after performing the lymphadenectomy, according to a table of random numbers performed in excel kuytools, then a compression bandage will be performed on all the patients and it will be controlled 24 hours postoperatively, the subsequent control will be weekly until the drain is removed. and / or the disappearance of the seroma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To develop seroma after surgery
Time Frame: Percentage, through study completion, an average of 2 months
Percentage of patients that receive Hemopatch® that develop seroma after surgery and percentage of patients that receive that develop seroma after extraction of the aspirative drainage.
Percentage, through study completion, an average of 2 months
total volumen of the seroma
Time Frame: from 24 hours until there is no seroma, assessed up to 2 months
The initial control will be performed 24 hours after the intervention, maintaining AD if the volume is greater than 30ml. All patients will be seen 7 days after surgery. The follow-up time will be weekly until there is no seroma, measuring the volume of the seroma extracted by puncture,
from 24 hours until there is no seroma, assessed up to 2 months
Seroma punctures
Time Frame: through study completion, an average of 2 months
the total number of punctures needed
through study completion, an average of 2 months
complications
Time Frame: from 24 hours until there is no complications, assessed up to 2 months
Other complications collected throughout the study include: bruising (yes / no), pain (yes / no), problems with aspiration drainage (yes / no)
from 24 hours until there is no complications, assessed up to 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life in patients
Time Frame: 1 week after surgery with Eortc QLQ-BR23
Compare the quality of life in patients after receiving either of these procedures using the Eortc QLQ-BR23 survey
1 week after surgery with Eortc QLQ-BR23
the costs
Time Frame: through study completion, an average of 1 year
Compare the costs of both procedures by quantifying the costs of materials and consult time used in both procedures
through study completion, an average of 1 year
body mass index
Time Frame: weight (kg) / height (m2). In the first consultation
body mass index
weight (kg) / height (m2). In the first consultation

Collaborators and Investigators

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

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

March 1, 2020

Primary Completion (Actual)

February 14, 2023

Study Completion (Actual)

February 14, 2023

Study Registration Dates

First Submitted

July 7, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (Actual)

July 27, 2020

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REDHEMOPACH

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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