UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060170 |
|---|---|
| Receipt number | R000068816 |
| Scientific Title | Superirotiy randomized clinical trial of surigical site infection after pancreaticoduodenectomy:Negative pressure wound therapy vs. conventional wound dressing |
| Date of disclosure of the study information | 2026/01/05 |
| Last modified on | 2025/12/23 08:31:18 |
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Basic information
Public title
Superirotiy randomized clinical trial of surigical site infection after pancreaticoduodenectomy:Negative pressure wound therapy vs. conventional wound dressing
Acronym
Superirotiy randomized clinical trial of surigical site infection after pancreaticoduodenectomy:Negative pressure wound therapy vs. conventional wound dressing
Scientific Title
Superirotiy randomized clinical trial of surigical site infection after pancreaticoduodenectomy:Negative pressure wound therapy vs. conventional wound dressing
Scientific Title:Acronym
Superirotiy randomized clinical trial of surigical site infection after pancreaticoduodenectomy:Negative pressure wound therapy vs. conventional wound dressing
Region
| Japan |
Condition
Condition
Patients with any diseases reqiring pancreaticoduodenectomy, and obtained written informed consent
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the role of NPWT for contribution to the reduction of SSI
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
30 days overall SSI rate
Key secondary outcomes
subgroup analyses, adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
NPWT 1 week after surgery
Interventions/Control_2
Conventional wound dressing 48 hours after surgery
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with any diseases requiring pancreaticoduodenectomy
Obtained written informed consent
Key exclusion criteria
Disagree with participating in this study
Allergy with dressing materials
Target sample size
79
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Umemura |
Organization
School of Medicine, Iwate Medical University
Division name
Department of Surgery
Zip code
028-3695
Address
2-1-1, Idaidori, Yahaba, Shiwa-gun, Iwate
TEL
019-613-7111
aumemura@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | Umemura |
| Last name | Kikuchi |
Organization
School of Medicine, Iwate Medical University
Division name
Department of Surgery
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba, Shiwa-gun, Iwate
TEL
019-613-7111
Homepage URL
kikukoji@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical Univerisity
Institute
Department
Personal name
Funding Source
Organization
Iwate Medical Univerisity
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iwate Medical Univerisity
Address
2-1-1 Idaidori, Yahaba, Shiwa-gun, Iwate
Tel
019-613-7111
aumemura@iwate-med.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
| 2026 | Year | 01 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 12 | Month | 23 | Day |
Last modified on
| 2025 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068816
