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.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess
1. Proportion of patients treated with Hemopatch who develop clinically
significant seroma during the first three post-operative months. Clinically
significant seroma defined as:
a. 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.
b. The presence of discomfort or pain caused by large amounts of
seroma, characterised by tenseness of the skin and aspiration is necessary
c. 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.
d. Seroma for which incision and drainage is necessary to treat abscess
or
infection.
Secondary outcome
To assess
1. 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.
2. The number of outpatient department visits, measured during the
first three months postoperative.
3. 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
Background summary
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, persistant fibrotic encapsulated seromas and
may even delay adjuvant therapies. 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 and fibrin
glue.
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.
Study 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 lympheadenectomy, 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.
Intervention
Application of Hemopatch after standard axillary lymph node dissection.
Study burden and risks
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. 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.
Dr. H. van der Hoffplein 1
Sittard 6162 BG
NL
Dr. H. van der Hoffplein 1
Sittard 6162 BG
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71255.096.19 |