A Trial Comparing Wound Drainage and Post-operative Complications With and Without the Use of EVICEL™ Fibrin Sealant in Thyroidectomy
- Registration Number
- NCT01226914
- Lead Sponsor
- Medical University of South Carolina
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo EVICEL 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. Evicel EVICEL 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.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method