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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003152
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Ishinomaki municipal hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003816

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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