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Efficacy of Fibrin Sealant to Reduce the Amount of Post-thyroidectomy Drain

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ClinicalTrials.gov Identifier: NCT01126060
Recruitment Status : Completed
First Posted : May 19, 2010
Results First Posted : December 19, 2011
Last Update Posted : December 19, 2011
Sponsor:
Information provided by:
Samsung Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Thyroid Carcinoma
Thyroidectomy
Interventions Drug: Usage of Fibrin sealant
Procedure: Thyroidectomy
Enrollment 78
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fibrin Sealant No Fibrin Sealant
Hide Arm/Group Description drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage) No usage of fibrin sealant No usage of alternative drugs
Period Title: Overall Study
Started 40 40
Completed 40 38
Not Completed 0 2
Reason Not Completed
Protocol Violation             0             2
Arm/Group Title Fibrin Sealant No Fibrin Sealant Total
Hide Arm/Group Description drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage) No usage of fibrin sealant No usage of alternative drugs Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
40
 100.0%
40
 100.0%
80
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
47.8  (9.6) 50.8  (10.8) 49.3  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
34
  85.0%
27
  67.5%
61
  76.3%
Male
6
  15.0%
13
  32.5%
19
  23.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 40 participants 40 participants 80 participants
40 40 80
1.Primary Outcome
Title Postoperative Drainage Amount
Hide Description method : measurement of drainage fluids from negative suction system every 8 hr until daily total amount reduces under 20mL
Time Frame serial measurement from 1day to 4day after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fibrin Sealant No Fibrin Sealant
Hide Arm/Group Description:
drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
No usage of fibrin sealant No usage of alternative drugs
Overall Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: mL
93.5  (30.7) 105.7  (31.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fibrin Sealant No Fibrin Sealant
Hide Arm/Group Description drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage) No usage of fibrin sealant No usage of alternative drugs
All-Cause Mortality
Fibrin Sealant No Fibrin Sealant
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fibrin Sealant No Fibrin Sealant
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Fibrin Sealant No Fibrin Sealant
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/40 (0.00%) 
realtive small number of patients to retrieve significant difference between two groups
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Man Ki Chung
Organization: Samsung medical center
Phone: 82-2-3410-1845
Responsible Party: Man Ki Chung/Assistant professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01126060     History of Changes
Other Study ID Numbers: 2009-12-093
First Submitted: April 15, 2010
First Posted: May 19, 2010
Results First Submitted: September 6, 2011
Results First Posted: December 19, 2011
Last Update Posted: December 19, 2011