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

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Thyroid Neoplasm; Goiter

Treatments: Drug: EVICEL

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01226914

EVICEL

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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55 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: EVICEL

Evicel

Experimental group

Description:

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.

Treatment:

Drug: EVICEL