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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023748
Receipt No. R000027363
Scientific Title Efficacy and safety of negative pressure wound therapy for perineal wound after abdonimo-perineal resection.
Date of disclosure of the study information 2016/08/29
Last modified on 2016/08/24

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Basic information
Public title Efficacy and safety of negative pressure wound therapy for perineal wound after abdonimo-perineal resection.
Acronym Efficacy and safety of negative pressure wound therapy after abdonimo-perineal resection.
Scientific Title Efficacy and safety of negative pressure wound therapy for perineal wound after abdonimo-perineal resection.
Scientific Title:Acronym Efficacy and safety of negative pressure wound therapy after abdonimo-perineal resection.
Region
Japan

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

Objectives
Narrative objectives1 Perineal wound infection after abdomino-perineal resection has high incidence, especially in inflammatory bowel disease. The aim of this study is to evaluate the efficacy and safety of negative pressure wound therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Incidence of wound infection during 30 post operative days..
Key secondary outcomes Duration for complete wound healing.
Safety(Post-operative adverse events)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 3 weeks of negative pressure wound therapy after surgery.
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
70 years-old >
Gender Male and Female
Key inclusion criteria Patients who were treated with abdomono-perineal resection.
Key exclusion criteria Patients with out consent.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoi Uchino
Organization Hyogo college of medicine
Division name Inflammatory Bowel Disease
Zip code
Address 1-1 Mukogawacho, Nishinomiya, Hyogo,Japan
TEL 0798-45-6371
Email motoi.uchino@nifty.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motoi Uchino
Organization Hyogo college of medicine
Division name Inflammatory Bowel Disease
Zip code
Address 1-1 Mukogawacho, Nishinomiya, Hyogo,Japan
TEL 0798-45-6371
Homepage URL
Email motoi.uchino@nifty.ne.jp

Sponsor
Institute Hyogo college of medicine
Institute
Department

Funding Source
Organization Hyogo college of medicine
Organization
Division
Category of Funding Organization Other
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 兵庫医科大学(兵庫県)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 29 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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 29 Day
Last follow-up date
2017 Year 11 Month 30 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 24 Day
Last modified on
2016 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027363

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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