Status:
COMPLETED
A Trial Comparing Wound Drainage and Post-operative Complications With and Without the Use of EVICEL™ Fibrin Sealant in Thyroidectomy
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Ethicon, Inc.
Conditions:
Thyroid Neoplasm
Goiter
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief 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™ pla...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Total bilirubin \< 2.6
- Serum Creatinine \< 2.0
- PTT and PT/INR within institutional normal limits
- Patients must sign informed consent for study participation
- Exclusion Criteria
- 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
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01226914
Start Date
June 1 2010
End Date
July 1 2014
Last Update
February 5 2019
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