Trial Outcomes & Findings for A Trial Comparing Wound Drainage and Post-operative Complications With and Without the Use of EVICEL™ Fibrin Sealant in Thyroidectomy (NCT NCT01226914)
NCT ID: NCT01226914
Last Updated: 2019-02-05
Results Overview
First 8 hours output (mL), Total output (mL), Drain time (hours), Hospital stay (hours), AEs
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
90 days
Results posted on
2019-02-05
Participant Flow
subjects undergoing total or partial thyroidectomy will be consented for this industry-sponsored prospective randomized placebo-controlled double-blind trial.
Subjects will be randomized to placebo or Evicel group based on a computer-generated random number sequence.
Participant milestones
| Measure |
EVICEL Group
|
Placebo Group
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
27
|
|
Overall Study
COMPLETED
|
28
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial Comparing Wound Drainage and Post-operative Complications With and Without the Use of EVICEL™ Fibrin Sealant in Thyroidectomy
Baseline characteristics by cohort
| Measure |
EVICEL Group
n=28 Participants
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.
|
Placebo Group
n=27 Participants
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.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
48.8 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
51.9 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
50.2 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 daysFirst 8 hours output (mL), Total output (mL), Drain time (hours), Hospital stay (hours), AEs
Outcome measures
| Measure |
EVICEL Group
n=28 Participants
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.
|
Placebo Group
n=27 Participants
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.
|
|---|---|---|
|
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
Interval 73.3 to 139.3
|
120 mL
Interval 68.8 to 161.5
|
Adverse Events
EVICEL
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EVICEL
n=28 participants at risk
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.
|
Placebo
n=27 participants at risk
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.
|
|---|---|---|
|
Endocrine disorders
hypocalcemia
|
3.6%
1/28 • Number of events 1 • Time from end of surgery to discharge was recorded for analysis. Adverse events were followed up to six months.
|
7.4%
2/27 • Number of events 2 • Time from end of surgery to discharge was recorded for analysis. Adverse events were followed up to six months.
|
|
Endocrine disorders
hypocalcemia tetany
|
7.1%
2/28 • Number of events 2 • Time from end of surgery to discharge was recorded for analysis. Adverse events were followed up to six months.
|
0.00%
0/27 • Time from end of surgery to discharge was recorded for analysis. Adverse events were followed up to six months.
|
|
Injury, poisoning and procedural complications
TVC paralysis
|
10.7%
3/28 • Number of events 3 • Time from end of surgery to discharge was recorded for analysis. Adverse events were followed up to six months.
|
3.7%
1/27 • Number of events 1 • Time from end of surgery to discharge was recorded for analysis. Adverse events were followed up to six months.
|
|
Injury, poisoning and procedural complications
Laryngeal edema
|
3.6%
1/28 • Number of events 1 • Time from end of surgery to discharge was recorded for analysis. Adverse events were followed up to six months.
|
0.00%
0/27 • Time from end of surgery to discharge was recorded for analysis. Adverse events were followed up to six months.
|
|
Injury, poisoning and procedural complications
asymptomatic hematoma
|
3.6%
1/28 • Number of events 1 • Time from end of surgery to discharge was recorded for analysis. Adverse events were followed up to six months.
|
0.00%
0/27 • Time from end of surgery to discharge was recorded for analysis. Adverse events were followed up to six months.
|
|
Injury, poisoning and procedural complications
Non-admit ED Incisional and Facial Swelling
|
3.6%
1/28 • Number of events 1 • Time from end of surgery to discharge was recorded for analysis. Adverse events were followed up to six months.
|
0.00%
0/27 • Time from end of surgery to discharge was recorded for analysis. Adverse events were followed up to six months.
|
Additional Information
Shaun A. Nguyen, MD, FAPCR
Medical University of South Carolina - Department of Otolaryngology - Head and Neck Surgery
Phone: 8437921356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place