UMIN-CTR Clinical Trial

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
Last 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
1st 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