A Trial Comparing Wound Drainage and Post-operative Complications With and Without the Use of EVICEL™ Fibrin Sealant in Thyroidectomy
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|ClinicalTrials.gov Identifier: NCT01226914|
Recruitment Status : Completed
First Posted : October 22, 2010
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Neoplasm Goiter||Drug: EVICEL||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||prospective randomized placebo-controlled double-blind trial.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Placebo Comparator: Placebo
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.
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.
- 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). [ Time Frame: 90 days ]First 8 hours output (mL), Total output (mL), Drain time (hours), Hospital stay (hours), AEs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226914
|Principal Investigator:||Joshua Hornig, MD||Medical University of South Carolina|
|Study Director:||Shaun A Nguyen, M.D.,CPI||Medical University of South Carolina|