An interventional study of Hemopatch in Axillary Lymph Node Dissection, ALND and Axillary Clearance, sponsored by Zuyderland Medisch Centrum. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-24.
Sponsored by Zuyderland Medisch Centrum · Not applicable, Interventional, and Treatment
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.
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.
101 studies on the registry are indexed under Seroma; 22 are open to participants now.
This study's enrollment of 62 is below the median of 100 across 92 interventional studies indexed under Seroma.
Browse Seroma studies →Zuyderland Medisch Centrum is the lead sponsor of 64 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Historical cohort of patients that underwent axillary clearance without hemopatch.
Prospective cohort of patient undergoing axillary clearance with hemopatch
Device: Hemopatch
Before closure of the wound this hemostatic sealant (Hemopatch), a pad of collagen derived from bovine dermis will be applied in the axilla
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: 1. 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. 2. The presence of discomfort or pain caused by large amounts of seroma, characterised by tenseness of the skin and aspiration is necessary 3. 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. 4. Seroma for which incision and drainage is necessary to treat abscess or infection.
Time frame: During the first three postoperative months
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.
Time frame: 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.
Time frame: During the first three postoperative months
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
Time frame: During the first three postoperative months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2020 to primary completion in Jun 2021, 11 months.
Of 43 non-industry interventional studies with no phase under Seroma, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 65. This study's 11 months is below that.
Counting every sponsor, half of 44 studies reached it within 34 months; a quarter within 17 and three quarters within 65.
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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Zuyderland Medisch Centrum