UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023748 |
|---|---|
| Receipt number | 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 16:20:47 |
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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
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
motoi.uchino@nifty.ne.jp
Sponsor or person
Institute
Hyogo college of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027363
