Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT02568085 |
| Other study ID # |
Arista for Thyroids |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2016 |
| Est. completion date |
June 2017 |
Study information
| Verified date |
August 2019 |
| Source |
University of California, San Francisco |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a single-blinded randomized controlled trial to evaluate the effectiveness of Arista
hemostatic matrix powder (Arista® AH, C. R. Bard, Inc. Davol, Warwick, RI) in reducing
drainage output after total thyroidectomy with and without lateral neck dissections.
Increased drainage in total thyroidectomy and neck dissection wound beds can lead to seroma
formation with possible secondary infection, delayed hospital discharge, and additional home
care needs for drain care. Arista is an inert plant based absorbable surgical hemostatic
powder that can be easily applied to broad surgical fields to reduce bleeding and seroma
rates. Therefore, its application to thyroidectomy and neck dissection wound beds may bear
significant potential benefit.
Description:
This is a single-blinded randomized controlled trial to evaluate the effectiveness of Arista
hemostatic matrix powder in reducing drainage output after total thyroidectomy with and
without lateral neck dissections. Increased drainage in total thyroidectomy and neck
dissection wound beds can lead to seroma formation with possible secondary infection, delayed
hospital discharge, and additional home care needs for drain care. Arista is an inert plant
based absorbable surgical hemostatic powder that can be easily applied to broad surgical
fields to reduce bleeding and seroma rates. Therefore, its application to thyroidectomy and
neck dissection wound beds may bear significant potential benefit.
Specific Aim 1: The main hypothesis of the study is that the use of Arista in total
thyroidectomy with and without lateral neck dissections prior to closure will reduce
postoperative drain outputs and time to drain removal compared to total thyroidectomy with
and without lateral neck dissection closed without Arista.
Specific Aim 2: This study will also evaluate the secondary hypotheses that Arista will
reduce postoperative hematoma and seroma rates and hospital length of stay in total
thyroidectomies with and without lateral neck dissections.
INTRODUCTION
Total thyroidectomy is an increasingly common procedure performed where the entire thyroid
gland is removed for either benign or malignant disease. Common indications include
multinodular goiter, Graves disease, and thyroid carcinoma. Between 2006 and 2011 the number
of total thyroidectomies performed in the United States increased by 12% per year, from
45,558 to 72,344 according the to the American Cancer Society. In 2011 48,000 total
thyroidectomies were performed for malignant disease which often requires additional lateral
neck dissection.
Although patients do very well after total thyroidectomy with over 90% 5-year survival for
patients with well-differentiated thyroid carcinoma, total thyroidectomy with and without
lateral neck dissection still carries the potential for serious complications including neck
hematomas or seromas. Postoperative fluid collections continue to be problematic after
thyroidectomy with or without lateral neck dissection with hematoma rates of 1-3% and seroma
rates of 4-7%. In order to try and reduce the rate of hematomas and seromas after total
thyroidectomy with or without lateral neck dissection, the majority of surgeons place closed
suction drains (CSDs) in the wound prior to closure. Surgeons generally use drains in an
attempt to identify, reduce, and or prevent hematomas and seromas even though there is little
evidence to support this practice.
At this institution, it is common practice to place single drain in the thyroid bed and
another drain in the neck of a lateral neck dissection is preformed and only remove drains
once the output is less than 30ml over a 24-hour period or 15ml over a 12-hour period with a
downward trend. Meeting this output volume criterion often takes several days. Often, a
patient will be given the decision to be discharged home with a drain or wait and continue
inpatient hospitalization until drain output requirements are met. Prolonged drain can lead
to increased infection risks and unnecessary hospital stay. According the Healthcare Cost and
Utilization Project, an average inpatient hospitalization in 2009 cost $2,000 per day, and is
increasing. The reduction of an average of just one hospital day per thyroidectomy patient
could potential save $144,688,000 dollars a year. An evaluation of Arista use on reducing
drain output may reveal unnecessary expenses related to increased hospital length of stay and
could lead to significant cost savings. Further, the associated morbidity and health care
costs of potential seroma or infected seroma complications may be avoided.
According to the manufacturer, Arista uses Microporous Polysaccharide Hemospheres (MPH)
technology to catalyze the clotting cascade and effectively dehydrate tissue to initiate
hemostasis in broad areas. Major advantages of Arista are that it has been shown to be safe
and effective across multiple surgical disciplines, is completely absorbed in 24-48 hours,
and contains no human or animal components.
Previous works support the idea that Arista could be effective in reducing postoperative
fluid collection and drainage time in free flap donor sites. However, this would be a new
application of Arista with wide applicability that has not been previously described.
Possible Influence On Clinical Practice
Total thyroidectomies with and without lateral neck dissections, and surgery in general, have
evolved in an era of increased attention to quality of life and cost savings. The most
radical neck dissections are increasingly being replaced by more focused "functional" and
"selective" neck dissections, during which the spinal accessory nerve, sternocleidomastoid
muscle, internal jugular vein, and cervical sensory nerves are preserved and a more narrowly
defined set of lymph node levels are excised, based on oncologic risk profiling. Finding
Arista can decrease total thyroidectomy with or without lateral neck dissection drain output
and lead to earlier drain removal could improve the quality of life of patients,
significantly decrease the cost of care, and potentially decrease drain-associated
infections.
This study seeks to critically evaluate current clinical practice paradigms to better
understand the potential benefit of Arista post thyroidectomy with or without lateral neck
dissection wound beds. A prospective, randomized, controlled, single-blinded trial is the
clearest methodology to evaluate the possible by limiting bias and confounding variables. No
clinical trial of this level has been performed on this topic; thus, this proposal is novel
and the findings of the study are potentially important.
SUBJECTS AND METHODS
Patient Population and Enrollment
All adult patients (18 years old and over) undergoing total thyroidectomy with or without
lateral neck dissection by one of two Head and Neck Surgery faculty members at UCSF will be
included in enrollment for the study and consecutively registered.
Exclusion criteria will consist of patient age under 18, requirement of postoperative
anticoagulant medications other than routine deep venous thrombosis prophylaxis (such as
warfarin), and presence of clotting or bleeding disorder.
Study Protocols and Surgical Description
If successfully enrolled to the study, a randomized packet containing the patient's research
ID number will be pulled and included into the patient's chart. Randomization will be done at
the initiation of the study by creating a randomization list with blocking and stratification
by surgeon. An envelope containing the patients randomized group assignment will not be
opened until the end of the procedure just prior to closure.
The patients will be randomized to one of four groups. Groups 1 and 2 will consist of
patients undergoing total thyroidectomy with possible central neck dissection but not lateral
neck dissection. Patients in Group 1 will have 3 grams of Arista applied diffusely to the
wound bed before primary closure. Patients in Group 2 will not have any Arista applied. Per
routine, patients in both groups will have a single 10 French Jackson-Pratt drain will be
placed within the thyroid bed and removed per a standardized protocol.
Groups 3 and 4 will consist of patients undergoing total thyroidectomy with lateral neck
dissection. Patients in Group 3 will have 3 grams of Arista applied diffusely to the thyroid
and neck wound bed before primary closure. Patients in Group 4 will not have any Arista
applied. All incisions will be closed in 3 layers with 3-0 vicryl, 4-0 monocryl, and 5-0 fast
absorbing sutures. All patients will receive standardized postoperative orders including
inpatient antibiotics not to exceed 24hrs (unless an infection is suspected) and DVT
prophylaxis; either weight based subcutaneous heparin or enoxaparin.
The drain will only be removed once output is less than 30ml per 24hr or 15ml per 12hr with
downward trend. All patients will receive similar postoperative instructions including wound
care, with and without drain. If the patient requires the drain to remain at time of
discharge, the patient is fully instructed on drain care, emptying, and recording. The
patient is then seen in the outpatient clinic, typically at approximately 7 after the
surgery, the drain is removed regardless of output.
A standardized physical exam will be performed on all patients every day of inpatient stay by
the chief resident and on postoperative appointment (5-8 days post-operatively) by the
attending surgeon to evaluate for clinical evidence of seroma and hematomas.
Physical exam will specifically include:
1. Inspect and palpate for presence fluctuance.
2. Inspect for color change, erythema or ecchymosis
3. Palpate for tenderness
All patients will be given a patient satisfaction questionnaire at their first postoperative
visit to evaluate their overall satisfaction with their hospital stay, their recovery and
healing of their wound, their comfort with home care, and level of pain. The validated
questionnaire, the measurement of quality of recovery (QoR-40), will be used.
Primary Endpoints and Outcomes
The primary outcome analyzed in this study will be total drain output (mL) in an effort to
determine if the addition of Arista to the wound bed decreases overall wound drainage and
drain output. Given that drain output influences time of drain removal, assessment will be
made to determine if timing of drain removal differs between groups.
Secondary Endpoints
Secondary outcomes will allow for a robust analysis and will include:
1. Development of hematoma.
2. Development of seroma.
3. Requirement of patient to be discharged with drain.
4. Hospital length of stay.
5. Need for any additional procedures secondary wound complications.
6. The quantitative outcome from the patient satisfaction questionnaire
