UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of negative pressure wound therapy for wound closure at ostomy site.
Title of the study (Brief title)	Efficacy of negative pressure wound therapy for ostomy wound.
Region	Japan

Condition
Condition	Inflammatory Bowel disease
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Object of this study is clarifing the efficacy and safety of the negative pressure wound therapy for the ostomy wound.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	Duration of wound healing.
Key secondary outcomes	Rate of wound infection

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	With negative pressure wound therapy
Interventions/Control_2	Without negative pressure wound therapy
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who undergo the closure of diverting ileostomy during divided surgical procedure.
Key exclusion criteria	Patients with immunosuppressive therapy which includes corticosteroid, immunomodurators or biologics at surgery of ostomy closure will be excluded.
Target sample size	30

Research contact person
Name of lead principal investigator	Kei Hirose
Organization	Hyogo college of medicine
Division name	department of Inflammatory Bowel disease
Address	1-1 Mukogawacho, Nishinomiya, Hyogo, Japan
TEL	0798-45-6371
Email	keih_2s@hotmail.co.jp

Public contact
Name of contact person	Kei Hirose
Organization	Hyogo College of Medicine
Division name	Department of Inflammatory Bowel Disease
Address	1-1 Mukogawacho, Nishinomiya, Hyogo, Japan
TEL	0798-45-6371
Homepage URL
Email	keih_2s@hotmail.co.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Hyogo College of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2014 Year 11 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 20 Day
Anticipated trial start date	2014 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2016 Year 08 Month 24 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	The efficacy was not proven.
Other related information

Management information
Registered date	2014 Year 10 Month 02 Day
Last modified on	2017 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017820