Trial Outcomes & Findings for Efficacy of Fibrin Sealant to Reduce the Amount of Post-thyroidectomy Drain (NCT NCT01126060)
NCT ID: NCT01126060
Last Updated: 2011-12-19
Results Overview
method : measurement of drainage fluids from negative suction system every 8 hr until daily total amount reduces under 20mL
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
78 participants
Primary outcome timeframe
serial measurement from 1day to 4day after surgery
Results posted on
2011-12-19
Participant Flow
Participant milestones
| Measure |
Fibrin Sealant
drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
|
No Fibrin Sealant
No usage of fibrin sealant No usage of alternative drugs
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Fibrin Sealant
drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
|
No Fibrin Sealant
No usage of fibrin sealant No usage of alternative drugs
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
2
|
Baseline Characteristics
Efficacy of Fibrin Sealant to Reduce the Amount of Post-thyroidectomy Drain
Baseline characteristics by cohort
| Measure |
Fibrin Sealant
n=40 Participants
drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
|
No Fibrin Sealant
n=40 Participants
No usage of fibrin sealant No usage of alternative drugs
|
Total
n=80 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
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 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
|
47.8 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
50.8 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
49.3 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: serial measurement from 1day to 4day after surgerymethod : measurement of drainage fluids from negative suction system every 8 hr until daily total amount reduces under 20mL
Outcome measures
| Measure |
Fibrin Sealant
n=38 Participants
drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
|
No Fibrin Sealant
n=40 Participants
No usage of fibrin sealant No usage of alternative drugs
|
|---|---|---|
|
Postoperative Drainage Amount
|
93.5 mL
Standard Deviation 30.7
|
105.7 mL
Standard Deviation 31.2
|
Adverse Events
Fibrin Sealant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Fibrin Sealant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place