UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003032 |
|---|---|
| Receipt number | 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 19:31:32 |
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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
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
tmizobuchi@faculty.chiba-u.jp
Sponsor or person
Institute
Department of General Thoracic Surgery, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003675
