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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032053
Receipt No. R000036566
Scientific Title Evaluation of negative pressure wound therapy for surgical site infection of ileostomy closed wound
Date of disclosure of the study information 2018/04/02
Last modified on 2019/03/31

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Basic information
Public title Evaluation of negative pressure wound therapy for surgical site infection of ileostomy closed wound
Acronym Evaluation of negative pressure wound therapy for surgical site infection of ileostomy closed wound
Scientific Title Evaluation of negative pressure wound therapy for surgical site infection of ileostomy closed wound
Scientific Title:Acronym Evaluation of negative pressure wound therapy for surgical site infection of ileostomy closed wound
Region
Japan

Condition
Condition ileostomy status
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the safety and efficacy of prophylactic negative pressure wound therapy for surgical site infection of ileostomy closed wounds
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes SSI incidence within 30 days after ileostomy closure
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 within 3 days after ileostomy closure
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Cases judged to be closed by patients with ileostomy
2) ECOG's Performance Status (PS) is 0 - 1
3) Cases with negative pressure woud therapy
4) Age is over 20 years old
5) The written consent has been obtained from himself / herself
Key exclusion criteria 1) Case of wound infection associated with ileal fistula before closing operation
2) Cases with severe liver disease
3) Cases with severe kidney disease
4) Pregnant women, cases of possible pregnancy
5) Other cases that the doctor deemed inappropriate
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Ichiro
Middle name
Last name Takemasa
Organization Sappro Medical University
Division name Department of Surgery, Surgical Oncology and Science
Zip code 0608556
Address S1W16,Chuoh-ku Sapporo,Hokkaido Japan
TEL 011-611-2111
Email okuya@sapmed.ac.jp

Public contact
Name of contact person
1st name Koichi
Middle name
Last name Okuya
Organization Sappro Medical University
Division name Department of Surgery, Surgical Oncology and Science
Zip code 0608556
Address S1W16,Chuoh-ku Sapporo,Hokkaido Japan
TEL 011-611-2111
Homepage URL
Email okuya@sapmed.ac.jp

Sponsor
Institute Sappro Medical University
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Sappro Medical University Hospital
Address S1W16,Chuoh-ku Sapporo,Hokkaido Japan
Tel 011-611-2111
Email ko-hamaya-923@sapmed.ac.jp

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
2018 Year 04 Month 02 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 Completed
Date of protocol fixation
2018 Year 01 Month 06 Day
Date of IRB
2018 Year 01 Month 11 Day
Anticipated trial start date
2018 Year 01 Month 11 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 02 Day
Last modified on
2019 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036566

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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