Clinical trial · Interventional
A Trial Comparing Wound Drainage and Post-operative Complications With and Without the Use of EVICEL™ Fibrin Sealant in Thyroidectomy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Goiter | — | UNRESOLVED | — |
| Thyroid Neoplasm | Thyroid Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EVICEL | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- 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.
- interventionNames
- Drug: EVICEL
- type
- EXPERIMENTAL
- label
- Evicel
- 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.
- interventionNames
- Drug: EVICEL
Primary outcomes (1)
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available