Goiter, Thyroid Neoplasm
Conditions
Keywords
EVICEL, Fibrin Sealant, Thyroidectomy
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™ 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.
Interventions
DRUGEVICEL
EVICEL
Sponsors
Ethicon, Inc.
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
prospective randomized placebo-controlled double-blind trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 90 days | First 8 hours output (mL), Total output (mL), Drain time (hours), Hospital stay (hours), AEs |
Participant flow
Recruitment details
subjects undergoing total or partial thyroidectomy will be consented for this industry-sponsored prospective randomized placebo-controlled double-blind trial.
Pre-assignment details
Subjects will be randomized to placebo or Evicel group based on a computer-generated random number sequence.
Participants by arm
| Arm | Count |
|---|---|
| EVICEL Group 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. | 28 |
| Placebo Group 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. | 27 |
| Total | 55 |
Baseline characteristics
| Characteristic | EVICEL Group | Placebo Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 27 Participants | 55 Participants |
| Age, Continuous | 48.8 years STANDARD_DEVIATION 15.2 | 51.9 years STANDARD_DEVIATION 11.5 | 50.2 years STANDARD_DEVIATION 11.2 |
| Sex: Female, Male Female | 24 Participants | 24 Participants | 48 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 27 |
| other Total, other adverse events | 9 / 28 | 3 / 27 |
| serious Total, serious adverse events | 0 / 28 | 0 / 27 |
Outcome results
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).
First 8 hours output (mL), Total output (mL), Drain time (hours), Hospital stay (hours), AEs
Time frame: 90 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EVICEL Group | 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 mL |
| Placebo Group | 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). | 120 mL |