Thyroid NeoplasmNCT01226914
A Trial Comparing Wound Drainage and Post-operative Complications With and Without the Use of EVICEL™ Fibrin Sealant in Thyroidectomy
A study testing EVICEL in people with Thyroid Neoplasm and Goiter, run by Medical University of South Carolina.
Trial summary
Primary Objectives To compare the amount of post-operative wound drainage between the group of patients in which EVICEL™ spray is utilized (Arm A), and the group of patients in which an EVICEL™ placebo is utilized (Arm B). To compare the length of time to drain removal between Arm A and Arm B. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Thyroid Neoplasm, Goiter
- What is being tested?
- EVICEL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have an initial diagnosis of thyroid neoplasmcarcinoma or goiter that requires total or hemithyroidectomy.
- Patients must have an ECOG performance status of 0-2
- Laboratory values must be within the following ranges:
- Platelet count > 100 k/mm3
- Hemoglobin > 10.0 g/dL
- WBCs > 3.0 k/mm3
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- Total bilirubin < 2.6
- Serum Creatinine < 2.0
- PTT and PT/INR within institutional normal limits
- Patients must sign informed consent for study participation
Who cannot join
- Evidence of distant metastasis of thyroid carcinoma
- Recurrent thyroid cancer
- Prior thyroid surgery or surgery to the neck.
- Patients with diagnosed coagulation disorders
- Prior irradiation to the neck area
- Prior chemotherapy for the current diagnosis
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- Patients on therapeutic warfarin
- Patients with psychological or cognitive issues that, in the opinion of the investigator, will make them unable to adequately report pain levels
- Patients in an immune deficient state
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial Comparing Wound Drainage and Post-operative Complications With and Without the Use of EVICEL™ Fibrin Sealant in Thyroidectomy
Primary Objectives
- To compare the amount of post-operative wound drainage between the group of patients in which EVICEL™ spray is utilized (Arm A), and the group of patients in which an EVICEL™ placebo is utilized (Arm B).
- To compare the length of time to drain removal between Arm A and Arm B. Secondary objectives
- To compare the incident or rates of seroma, hematoma, and post-operative edema between the two groups.
- To compare the reported pain experienced in each group at selected time points using a standard numerical rating scale (NRS).
- To compare the length of hospital stay between the two groups of patients.
- Conditions
- Thyroid Neoplasm, Goiter
- Being tested
- EVICEL
- Keywords
- EVICEL, Fibrin Sealant, Thyroidectomy
- Medical subject headings
- Thyroid Neoplasms, Goiter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVICELDrug
EVICEL
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | For subjects in the placebo group, saline was drawn into the applicator and aerosolized in a similar fashion; it was allowed to remain in the wound during closure. Receives: Drug: EVICEL |
| Evicel | Experimental | For subjects in the treatment group, Evicel was applied in the usual manner by study personnel, with 5mL of each component drawn into a two-barrel syringe device and aerosolized using a pedal-controlled inert gas supply. Receives: Drug: EVICEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Compare the Amount of Post-operative Wound Drainage Between the Group of Patients in Which EVICEL™ Spray is Utilized (Arm A), and the Group of Patients in Which an EVICEL™ Placebo is Utilized (Arm B).
First 8 hours output (mL), Total output (mL), Drain time (hours), Hospital stay (hours), AEs
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Thyroid NeoplasmStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized placebo-controlled double-blind trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon, Inc.
- Responsible party
- Principal investigator, Shaun A. Nguyen, Medical University of South Carolina
- Investigators
- Joshua Hornig, MD, Principal investigator, Medical University of South CarolinaShaun A Nguyen, M.D.,CPI, Study director, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226914
- Sponsor's protocol ID
- EVICEL
- Status last verified
- Jan 2019
- First submitted
- 21 Oct 2010
- Last updated
- 5 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial Comparing Wound Drainage and Post-operative Complications With and Without the Use of EVICEL™ Fibrin Sealant in Thyroidectomy
- ClinicalTrials.gov ID
- NCT01226914
- Acronym / sponsor ID
- EVICEL
- Conditions
- Thyroid Neoplasm, Goiter
- Keywords
- EVICEL, Fibrin Sealant, Thyroidectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Ethicon, Inc.
- Study start
- Jun 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 22 Oct 2010 (estimated)
- Results
- Posted 5 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives
- To compare the amount of post-operative wound drainage between the group of patients in which EVICEL™ spray is utilized (Arm A), and the group of patients in which an EVICEL™ placebo is utilized (Arm B).
- To compare the length of time to drain removal between Arm A and Arm B. Secondary objectives
- To compare the incident or rates of seroma, hematoma, and post-operative edema between the two groups.
- To compare the reported pain experienced in each group at selected time points using a standard numerical rating scale (NRS).
- To compare the length of hospital stay between the two groups of patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- prospective randomized placebo-controlled double-blind trial.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: EVICELFor subjects in the placebo group, saline was drawn into the applicator and aerosolized in a similar fashion; it was allowed to remain in the wound during closure. |
| Evicel | Experimental | Drug: EVICELFor subjects in the treatment group, Evicel was applied in the usual manner by study personnel, with 5mL of each component drawn into a two-barrel syringe device and aerosolized using a pedal-controlled inert gas supply. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must have an initial diagnosis of thyroid neoplasmcarcinoma or goiter that requires total or hemithyroidectomy.
- Patients must have an ECOG performance status of 0-2
- Laboratory values must be within the following ranges:
- Patients must sign informed consent for study participation
Key exclusion criteria (9 listed)
- Evidence of distant metastasis of thyroid carcinoma
- Recurrent thyroid cancer
- Prior thyroid surgery or surgery to the neck.
- Patients with diagnosed coagulation disorders
- Prior irradiation to the neck area
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 |
|---|---|---|
| EVICELEVICEL | Drug | Evicel, Placebo |
Primary outcome
To Compare the Amount of Post-operative Wound Drainage Between the Group of Patients in Which EVICEL™ Spray is Utilized (Arm A), and the Group of Patients in Which an EVICEL™ Placebo is Utilized (Arm B).
Time frame: 90 days
First 8 hours output (mL), Total output (mL), Drain time (hours), Hospital stay (hours), AEs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joshua Hornig, MD principal investigator
Medical University of South Carolina
Shaun A Nguyen, M.D.,CPI study director
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
A study testing EVICEL in people with Thyroid Neoplasm and Goiter, run by Medical University of South Carolina.
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 10 inclusion and 9 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: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Compare the Amount of Post-operative Wound Drainage Between the Group of Patients in Which EVICEL™ Spray is Utilized (Arm A), and the Group of Patients in Which an EVICEL™ Placebo is Utilized (Arm B). (time frame: 90 days). 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 5 Feb 2019.