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

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01126060
First received: April 15, 2010
Last updated: November 15, 2011
Last verified: November 2011
Results First Received: September 6, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Thyroid Carcinoma
Thyroidectomy
Interventions: Drug: Usage of Fibrin sealant
Procedure: Thyroidectomy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Fibrin Sealant   No Fibrin Sealant
STARTED   40   40 
COMPLETED   40   38 
NOT COMPLETED   0   2 
Protocol Violation                0                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   Fibrin Sealant   No Fibrin Sealant   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   40   80 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   40   40   80 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.8  (9.6)   50.8  (10.8)   49.3  (10.3) 
Gender 
[Units: Participants]
     
Female   34   27   61 
Male   6   13   19 
Region of Enrollment 
[Units: Participants]
     
Korea, Republic of   40   40   80 


  Outcome Measures

1.  Primary:   Postoperative Drainage Amount   [ Time Frame: serial measurement from 1day to 4day after surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
realtive small number of patients to retrieve significant difference between two groups


  More Information
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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
e-mail: manki.chung@samsung.com



Responsible Party: Man Ki Chung/Assistant professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01126060     History of Changes
Other Study ID Numbers: 2009-12-093
Study First Received: April 15, 2010
Results First Received: September 6, 2011
Last Updated: November 15, 2011
Health Authority: South Korea: Institutional Review Board