N/A
N=55
A Trial Comparing Wound Drainage and Post-operative Complications With and Without the Use of EVICEL™ Fibrin Sealant in Thyroidectomy
Thyroid Neoplasm · Goiter
Bottom Line
View on ClinicalTrials.gov: NCT01226914 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: 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 mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EVICEL (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Jul 2014
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 | — |
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.
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
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.