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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

Baseline Characteristics

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
Number of Participants [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 ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

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

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

No publications provided

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