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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


N/A
18 Years
N/A
Open (Enrolling by invite only)
Both
Thyroid Neoplasm, Goiter

Thank you

Trial Information

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

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

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).

Outcome Time Frame:

one year

Safety Issue:

Yes

Principal Investigator

Joshua Hornig, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of South Carolina

Authority:

United States: Institutional Review Board

Study ID:

EVICEL

NCT ID:

NCT01226914

Start Date:

June 2010

Completion Date:

May 2015

Related Keywords:

  • Thyroid Neoplasm
  • Goiter
  • EVICEL, Fibrin Sealant, Thyroidectomy
  • Neoplasms
  • Thyroid Neoplasms
  • Goiter
  • Postoperative Complications

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