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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003032
Receipt No. R000003675
Scientific Title Comparison of in vivo prophylactic activities of VICRYL* Plus and VICRYL*: Antimicrobial suture closure of thoracic drainage tube for lung cancer surgery: A phase II randomised study
Date of disclosure of the study information 2010/01/14
Last modified on 2010/07/18

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Basic information
Public title Comparison of in vivo prophylactic activities of VICRYL* Plus and VICRYL*: Antimicrobial suture closure of thoracic drainage tube for lung cancer surgery: A phase II randomised study
Acronym Comparison of in vivo prophylactic activities of VICRYL* Plus and VICRYL*: Antimicrobial suture closure of thoracic drainage tube for lung cancer surgery
Scientific Title Comparison of in vivo prophylactic activities of VICRYL* Plus and VICRYL*: Antimicrobial suture closure of thoracic drainage tube for lung cancer surgery: A phase II randomised study
Scientific Title:Acronym Comparison of in vivo prophylactic activities of VICRYL* Plus and VICRYL*: Antimicrobial suture closure of thoracic drainage tube for lung cancer surgery
Region
Japan

Condition
Condition Lung cancer
Classification by specialty
Infectious disease Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Comparison of in vivo prophylactic activities of VICRYL* and VICRYL* for fixation to chest drainage tube on lung cancer parients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Wound infection rate
Key secondary outcomes 1 Wound dehiscence rate
2 Safety
3 Colonization rate on the wound and suture

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 VICRYL PLUS*
Interventions/Control_2 VICRYL*
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who agree with enrollment of this study
Performance Status(ECOG Scale): 0 or 1
Patients suffer from lung cancer undergoing thoracotomy as curative surgey except for wedge resection
White blood cell count > 3000/mm3
Noutrophilic leukocyte count > 1500/mm3
Platelet count > 75,000/mm3
Hemoglobin = or > 9.0g/dl
AST(GOT)/ALT(GPT) = or <100 IU/L
Total bilirubin = or < 2.0mg/dl
PaO2 = or > 60Torr
Creatinine clearance = or > 50ml/min [with Cockcroft-Gault method]
or serum creatin level: within normal limits
Key exclusion criteria Patients with pre-operative chemotherapy
Patients with pre-operative radiation therapy
Patients with former malignant disease as medical history
Target sample size 106

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichiro Yoshino
Organization Graduate School of Medicine, Chiba University
Division name Department of General Thoracic Surgery
Zip code
Address 1-8-1 Inohana, Chiba-shi, Chiba, Japan 271-8511
TEL +81-43-222-7171
Email

Public contact
Name of contact person
1st name
Middle name
Last name Teruaki Mizobuchi
Organization Graduate School of Medicine, Chiba University
Division name Department of General Thoracic Surgery
Zip code
Address 1-8-1 Inohana, Chiba-shi, Chiba, Japan 271-8511
TEL +81-43-222-7171
Homepage URL
Email tmizobuchi@faculty.chiba-u.jp

Sponsor
Institute Department of General Thoracic Surgery, Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2010 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 01 Month 13 Day
Last modified on
2010 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003675

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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