Evaluating Hemopatch in Reducing Seroma Related Complications Following Axillary Lymph Node Dissection: a Pilot Study (HEIDI)
Primary Purpose
Axillary Lymph Node Dissection, ALND, Axillary Clearance
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Hemopatch
Sponsored by
About this trial
This is an interventional treatment trial for Axillary Lymph Node Dissection
Eligibility Criteria
Inclusion Criteria:
- Male and female patients of 18 years or older.
- Patients with melanoma and indication for axillary lymph node dissection.
- Patients with breast cancer and indication for breast conserving therapy and axillary lymph node dissection
- Patients with an indication for secondary axillary lymph node dissection.
Exclusion Criteria:
- Patients with breast cancer who have an indication for modified radical mastectomy.
- Unable to comprehend implications and extent of study and sign for informed consent
- Pregnant women
- Patients included in another breast related clinical trial
Sites / Locations
- Zuyderland Medisch Centrum
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Conventional
Intervention
Arm Description
Historical cohort of patients that underwent axillary clearance without hemopatch.
Prospective cohort of patient undergoing axillary clearance with hemopatch
Outcomes
Primary Outcome Measures
Proportion of patients treated with Hemopatch who develop clinically significant seroma during the first three post-operative months
Proportion of patients treated with Hemopatch who develop clinically significant seroma during the first three post-operative months. Clinically significant seroma defined as:
Wound healing is at risk due to seroma (wound break down, seroma leakage, necrosis) and possibly operative debriding of the wound or use of vacuum assisted wound therapy is necessary.
The presence of discomfort or pain caused by large amounts of seroma, characterised by tenseness of the skin and aspiration is necessary
The presence of contaminated/ infected seroma, and aspiration is necessary to treat infection. All patients that undergo seroma aspiration due to infection will also be treated with a one week course of Augmentin 625 mg 3 times daily.
Seroma for which incision and drainage is necessary to treat abscess or infection.
Secondary Outcome Measures
Surgical site infection (SSI) rate
Surgical site infection (SSI) rate, defined as redness, pain, heat or swelling at the site of the incision or by the drainage of pus. Infection rate will be measured by A) the need for antibiotics, B) seroma aspiration due to infection or C) surgical drainage during the first three postoperative months.
The number of outpatient department visits
Number of unplanned visits to the ER or outpatient clinic. Planned visits are standard follow-up outpatient clinic visits which are defined preoperatively. Unplanned visits are defined as any visit to the outpatient clinic which is necessary due to an adverse event.
Number of days before removal of axillary drainage and axillary drainage output.
Number of days before removal of axillary drainage and axillary drainage output. According to current guidelines the drain is always removed no later than five days, earlier if drain output is < 50 ml/ 24 hours
Full Information
NCT ID
NCT04185480
First Posted
December 2, 2019
Last Updated
September 23, 2021
Sponsor
Zuyderland Medisch Centrum
1. Study Identification
Unique Protocol Identification Number
NCT04185480
Brief Title
Evaluating Hemopatch in Reducing Seroma Related Complications Following Axillary Lymph Node Dissection: a Pilot Study
Acronym
HEIDI
Official Title
Evaluating Hemopatch in Reducing Seroma Related Complications Following Axillary Lymph Node Dissection: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 16, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zuyderland Medisch Centrum
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
To evaluate if the use of Hemopatch in axillary lymph node dissection shows potential in reducing clinically significant seroma and seroma related complications, which might serve as a basis for a randomized controlled trial.
Detailed Description
Rationale:
Sentinel lymph node biopsy has reduced the number of patients needing to undergo axillary lymph node dissection (ALND). However, axillary lymph node dissection is part of curative therapy for a large group of patients with advanced invasive breast cancers and melanoma. Seroma may cause symptomatic discomfort requiring needle aspiration and is often associated with infection, wound dehiscence, skin necrosis, persistent fibrotic encapsulated seromas and may even delay adjuvant therapies [1]. Therefore, extensive research in finding the best technique in reducing seroma is needed.
Substances intended to seal small blood vessels by triggering collagen and fibrinogen synthesis supporting surgical hemostasis, are assumed to be able to contribute to sealing of these lymphatic vessels. Contradicting results were found in the effect of several fibrin-glue coated collagen patches [2-5] and fibrin glue [6,7]. Furthermore, the use of electrothermal bipolar vessel sealing system (LigaSure) in axillary dissection showed no significant reduction in rate of aspiration of seroma [8].
This pilot study is intended to assess the value of a haemostatic sealant (Hemopatch), a pad of collagen derived from bovine dermis, coated with NHS-PEG (pentaerythritol polyethylene glycol ether tetra-succinimidyl glutarate), in reducing seroma related complications after ALND with the advantage that this sealant is pliable and flexible.
Objective:
To evaluate if the use of Hemopatch in axillary lymph node dissection shows potential in reducing clinically significant seroma and seroma related complications, which might serve as a basis for a randomized controlled trial.
Study design:
A prospective cohort will be compared to a historical control group. Eighteen consecutive patients will undergo axillary lymph node dissection and after completion of lymphadenectomy, Hemopatch will be applied to the axillary surgical field. These results will be compared to the results of a historical control group consisting of 46 patients who have undergone ALND without the Hemopatch between January 2014 and December 2018.
Follow-up will be conducted for three months postoperatively.
Study population:
Patients of 18 years or older, diagnosed with stage III melanoma or breast cancer and indication for wide local excision (WLE) and/or axillary lymphadenectomy (ALND).
Intervention (if applicable):
Application of Hemopatch after standard axillary lymph node dissection.
Main study parameters/endpoints:
Proportion of patients treated with Hemopatch who develop clinically significant seroma.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Patients will be informed about the study before inclusion in the outpatient clinic. Informed consent will be obtained in the outpatient clinic a week after patients were initially informed. Postoperative check-ups will be done more frequently. Standard postoperative check-ups are planned at one week and three months. Additional study postoperative check-up will be performed at six weeks. Therefore, patients will be required to undergo one additional check-up. During out patients' visits, the wound will be evaluated and patients will be asked to fill in a questionnaire. Application of the Hemopatch is expected to reduce clinically significant seroma after ALND. The only potential risk for the patient is that the Hemopatch is ineffective.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axillary Lymph Node Dissection, ALND, Axillary Clearance, Seroma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A prospective cohort will be compared to a historical control group.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional
Arm Type
No Intervention
Arm Description
Historical cohort of patients that underwent axillary clearance without hemopatch.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Prospective cohort of patient undergoing axillary clearance with hemopatch
Intervention Type
Device
Intervention Name(s)
Hemopatch
Intervention Description
Before closure of the wound this hemostatic sealant (Hemopatch), a pad of collagen derived from bovine dermis will be applied in the axilla
Primary Outcome Measure Information:
Title
Proportion of patients treated with Hemopatch who develop clinically significant seroma during the first three post-operative months
Description
Proportion of patients treated with Hemopatch who develop clinically significant seroma during the first three post-operative months. Clinically significant seroma defined as:
Wound healing is at risk due to seroma (wound break down, seroma leakage, necrosis) and possibly operative debriding of the wound or use of vacuum assisted wound therapy is necessary.
The presence of discomfort or pain caused by large amounts of seroma, characterised by tenseness of the skin and aspiration is necessary
The presence of contaminated/ infected seroma, and aspiration is necessary to treat infection. All patients that undergo seroma aspiration due to infection will also be treated with a one week course of Augmentin 625 mg 3 times daily.
Seroma for which incision and drainage is necessary to treat abscess or infection.
Time Frame
During the first three postoperative months
Secondary Outcome Measure Information:
Title
Surgical site infection (SSI) rate
Description
Surgical site infection (SSI) rate, defined as redness, pain, heat or swelling at the site of the incision or by the drainage of pus. Infection rate will be measured by A) the need for antibiotics, B) seroma aspiration due to infection or C) surgical drainage during the first three postoperative months.
Time Frame
During the first three postoperative months
Title
The number of outpatient department visits
Description
Number of unplanned visits to the ER or outpatient clinic. Planned visits are standard follow-up outpatient clinic visits which are defined preoperatively. Unplanned visits are defined as any visit to the outpatient clinic which is necessary due to an adverse event.
Time Frame
During the first three postoperative months
Title
Number of days before removal of axillary drainage and axillary drainage output.
Description
Number of days before removal of axillary drainage and axillary drainage output. According to current guidelines the drain is always removed no later than five days, earlier if drain output is < 50 ml/ 24 hours
Time Frame
During the first three postoperative months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients of 18 years or older.
Patients with melanoma and indication for axillary lymph node dissection.
Patients with breast cancer and indication for breast conserving therapy and axillary lymph node dissection
Patients with an indication for secondary axillary lymph node dissection.
Exclusion Criteria:
Patients with breast cancer who have an indication for modified radical mastectomy.
Unable to comprehend implications and extent of study and sign for informed consent
Pregnant women
Patients included in another breast related clinical trial
Facility Information:
Facility Name
Zuyderland Medisch Centrum
City
Sittard
State/Province
Limburg
ZIP/Postal Code
6162 BG
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluating Hemopatch in Reducing Seroma Related Complications Following Axillary Lymph Node Dissection: a Pilot Study
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