HemopatchPhase 4NCT04904653
The Effectiveness of Hemopatch® in the Reduction of Post-surgical Serous Drainage
A Phase 4 study testing Hemopatch in people with Hemopatch and Breast Cancer, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hemopatch, Breast Cancer, Axillary Lymphadenectomy
- What is being tested?
- Hemopatch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteSpain
- Study dates
- 8 Nov 2021to Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Preoperative:
- Female gender
- Age ≥ 18 years
- Breast cancer N+
- Conservative Surgery: Lumpectomy or Quadrantectomy
- Berg levels 1-2 axillary lymphadenectomy
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- 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
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
General Surgery and Digestive System Service
Toledo, 45004
Justo Álvarez Martín, MD, justoam66@gmail.com
About this study
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
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
- Being tested
- Hemopatch, Control group
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemopatchDevice
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
Control groupOther
No sealant (liquid, gel or patch) + suction drain
| Study group | Role | What they receive |
|---|---|---|
| Hemopatch Group: | Experimental | Hemopatch + suction drainage Receives: Device: Hemopatch |
| Control group | Other | No sealant (liquid, gel or patch) + suction drain Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: In the last 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start8 Nov 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemopatchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Asociación De Cirujanos De Mama De Toledo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904653
- Sponsor's protocol ID
- HVST-HEMO-20
- Status last verified
- Mar 2024
- First submitted
- 19 May 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04904653
- Acronym / sponsor ID
- HVST-HEMO-20
- Conditions
- Hemopatch, Breast Cancer, Axillary Lymphadenectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Asociación De Cirujanos De Mama De Toledo
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Hemopatch Group: | Experimental | Device: HemopatchHemopatch + suction drainage |
| Control group | Other | Other: Control groupNo sealant (liquid, gel or patch) + suction drain |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female gender
- Age ≥ 18 years
- Breast cancer N+
- Conservative Surgery: Lumpectomy or Quadrantectomy
- Berg levels 1-2 axillary lymphadenectomy
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemopatchHEMOPATCH 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 | Device | Hemopatch Group: |
| Control groupNo sealant (liquid, gel or patch) + suction drain | Other | Control group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Hemopatch
Not yet recruiting
Hemopatch Implication After Axillary Dissection for Breast Cancer
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hemopatch in people with Hemopatch and Breast Cancer, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María García Ávila, MD (638432910, garciaavilamaria@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total volume in milliliters (ml) of drainage (time frame: In the last 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.