UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003152 |
|---|---|
| Receipt number | R000003816 |
| Scientific Title | A randomised prospective trial, effectiveness of subcutaneous drains for abdominal wound closure |
| Date of disclosure of the study information | 2010/02/09 |
| Last modified on | 2011/02/14 19:03:54 |
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Basic information
Public title
A randomised prospective trial, effectiveness of subcutaneous drains for abdominal wound closure
Acronym
A prospective trial, role of subcutaneous drains for abdominal wound closure
Scientific Title
A randomised prospective trial, effectiveness of subcutaneous drains for abdominal wound closure
Scientific Title:Acronym
A prospective trial, role of subcutaneous drains for abdominal wound closure
Region
| Japan |
Condition
Condition
colonic disease
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate effectiveness of subcutaneous drains for prevent surgical site infection on laparotomic colectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Surgical site infection, within 30 postoperative days
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
without subcutaneous drain for wound closure
Interventions/Control_2
with subcutaneous drain for wound closure
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
laparotomic colectomy
wound classification 2 or under
subcutaneous fat tissue, 0.5cm or over
ASA score 3 or under
WBC 3500-12000/microliter
Plt 100,000/ microliter or over
Hb 8.0mg/dl or over
serum Cr 1.0 mg/dl or under
Total Bil. 1.5 times 1.2 mg/dl or under
serum Alb 2.0 mg/dl or over
Key exclusion criteria
DM with HbA1c more than 8.0 %
COPD with PaO2 less than 60 mmHg
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuyuki Uchiyama |
Organization
Ishinomaki municipal hospital
Division name
Department of surgery
Zip code
Address
1-7-20 Minamihamamachi Ishinomaki-city Miyagi-ken
TEL
0225-23-3200
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Ishinomaki municipal hospital
Division name
Department of surgery
Zip code
Address
1-7-20 Minamihamamachi Ishonomaki-city Miyagi-ken
TEL
0225-23-3200
Homepage URL
Sponsor or person
Institute
Ishinomaki municipal hospital
Institute
Department
Personal name
Funding Source
Organization
Ishinomaki municipal hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
石巻市立病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 09 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 08 | Day |
Last modified on
| 2011 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003816
