UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037996 |
|---|---|
| Receipt number | R000043314 |
| Scientific Title | Prospective study of efficacy of negative pressure wound therapy for open wound after contaminated abdominal surgery and surgical site infection after gastrointestinal surgery |
| Date of disclosure of the study information | 2019/09/13 |
| Last modified on | 2021/03/31 13:44:06 |
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Basic information
Public title
Prospective study of efficacy of negative pressure wound therapy for open wound after contaminated abdominal surgery and surgical site infection after gastrointestinal surgery
Acronym
Prospective study of efficacy of negative pressure wound therapy for open wound after contaminated abdominal surgery and surgical site infection after gastrointestinal surgery
Scientific Title
Prospective study of efficacy of negative pressure wound therapy for open wound after contaminated abdominal surgery and surgical site infection after gastrointestinal surgery
Scientific Title:Acronym
Prospective study of efficacy of negative pressure wound therapy for open wound after contaminated abdominal surgery and surgical site infection after gastrointestinal surgery
Region
| Japan |
Condition
Condition
Surgical site infection
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of negative pressure wound therapy for open wound after contaminated abdominal surgery and surgical site infection after gastrointestinal surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The duration from incidence of surgical site infection to wound healing
Key secondary outcomes
The postoperative hospital stay, the cost of hospitalization, the presence of reopened wound, the presence and degree of 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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
For the patients with open wound after contaminated abdominal surgery and surgical site infection after gastrointestinal surgery, unroofing and debridement of infected wound is performed. Therefore, negative pressure wound therapy is started and continued for 1-2 weeks. After recognizing a formation of wound granulation, the wound is closed by suture.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1, The patients with surgical site infection after contaminated abdominal surgery and surgical site infection after gastrointestinal surgery
2, Older than 20 years old
3, ECOG performance status of 0 to 2
4, Documented informed consent
Key exclusion criteria
1, Naked blood vessel suspected of bleeding or surgical site infection to directly contact to other organs or the presence of fistula to abdominal cavity.
2, The presence of organ/space surgical site infection
3, As determined by the principal investigator or the sub-investigator the subject is not adequate to participate in the study.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Junzo |
| Middle name | |
| Last name | Shimizu |
Organization
Toyonaka Municipal Hospital
Division name
Department of Surgery
Zip code
560-8565
Address
4-1-1 Shibahara, Toyonaka, Osaka, Japan
TEL
+81-6-6843-0101
ai.npwt.organizer@gmail.com
Public contact
Name of contact person
| 1st name | Kozo |
| Middle name | |
| Last name | Noguchi |
Organization
Toyonaka Municipal Hospital
Division name
Department of Surgery
Zip code
560-8565
Address
4-1-1 Shibahara, Toyonaka, Osaka, Japan
TEL
+81-6-6843-0101
Homepage URL
ai.npwt.organizer@gmail.com
Sponsor or person
Institute
Clinical study group of AI-NPWT
Institute
Department
Personal name
Funding Source
Organization
Clinical study group of AI-NPWT
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
Toyonaka Municipal Hospital
Address
4-1-1 Shibahara, Toyonaka, Osaka, Japan
Tel
+81-6-6843-0101
rinsyoukenkyuu@city.toyonaka.osaka.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
| 2019 | Year | 09 | Month | 13 | 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
| 2019 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 12 | Day |
Last modified on
| 2021 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043314
