UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective study of negative pressure wound therapy with instillation and dwelling at stoma closure site
Acronym	Retrospective study of negative pressure wound therapy with instillation and dwelling at stoma closure site
Scientific Title	Retrospective study of negative pressure wound therapy with instillation and dwelling at stoma closure site
Scientific Title:Acronym	Retrospective study of negative pressure wound therapy with instillation and dwelling at stoma closure site
Region	Japan

Condition
Condition	colorectal disease
Classification by specialty	Surgery in general Gastrointestinal surgery Operative medicine Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the use of a negative pressure wound therapy with instillation and dwelling at stoma closure site.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of postoperative Surgical Site Infection
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients who underwent stoma closure 2. Written informed consent is obtained
Key exclusion criteria	1. Patients aged less 15 years old 2. Patients who could not be tracked in medical records 3. Those considered inappropriate for participation in this trial
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yoshinori Middle name Last name Yane
Organization	Kindai University
Division name	Surgery
Zip code	589-8511
Address	377-2 Ohno higashi, Osaka sayama Osaka, 589-8511, Japan
TEL	072-366-0221
Email	yaneyoshinori0127@med.kindai.ac.jp

Public contact
Name of contact person	1st name Yoshinori Middle name Last name Yane
Organization	Kindai University
Division name	Surgery
Zip code	589-8511
Address	377-2 Ohno higashi, Osaka sayama Osaka, 589-8511, Japan
TEL	072-366-0221
Homepage URL
Email	yaneyoshinori0127@med.kindai.ac.jp

Sponsor
Institute	Department of Surgery, Faculty of Medicine, Kindai University
Institute
Department

Funding Source
Organization	Department of Surgery, Faculty of Medicine, Kindai University
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	Kindai University Hospital IRB
Address	377-2 Ohno higashi, Osaka sayama Osaka, 589-8511, Japan
Tel	072-366-0221
Email	zizen@med.kindai.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	2021 Year 06 Month 04 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	103
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	No longer recruiting
Date of protocol fixation	2020 Year 10 Month 12 Day
Date of IRB	2020 Year 11 Month 19 Day
Anticipated trial start date	2020 Year 11 Month 20 Day
Last follow-up date	2025 Year 11 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This research is an observational study.

Management information
Registered date	2021 Year 06 Month 04 Day
Last modified on	2021 Year 06 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050674