N/A Completed N=55 Randomized Triple-blind Supportive Care

A Trial Comparing Wound Drainage and Post-operative Complications With and Without the Use of EVICEL™ Fibrin Sealant in Thyroidectomy

Source: ClinicalTrials.gov NCT01226914 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcomePrimary: 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). — 96.3; 120 mL

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. 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.

Outcome Measures

Outcome	Result	p-value
PRIMARY 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).	96.3; 120	—

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT01226914). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.