UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032458 |
|---|---|
| Receipt number | R000035980 |
| Scientific Title | Efficacy of vacuum assisted closure therapy for preventing drive-line infections after left ventricular assist device implantaion. |
| Date of disclosure of the study information | 2018/05/02 |
| Last modified on | 2023/11/05 09:37:31 |
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Basic information
Public title
Efficacy of vacuum assisted closure therapy for preventing drive-line infections after left ventricular assist device implantaion.
Acronym
Efficacy of VAC therapy for preventing DLI after LVAD implantation.
Scientific Title
Efficacy of vacuum assisted closure therapy for preventing drive-line infections after left ventricular assist device implantaion.
Scientific Title:Acronym
Efficacy of VAC therapy for preventing DLI after LVAD implantation.
Region
| Japan |
Condition
Condition
advanced heart failure
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the safety and effectiveness of vacuum assisted closure therapy for preventing drive-line infections after left ventricular assist device implantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome is drive-line infections(DLI) defined as clinical evidence of DLI accompanied by a positive bacterial swab and need for antibiotics.
Key secondary outcomes
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
Vacuum assisted closure therapy is performed for the drive-line wound site for 7 days after left ventricular assist device implantation.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patient who undergoes implantation of left ventricular assist device as bridge to transplantation.
2) 16 years old or older.
3) Patient who understands the purpose of this study and consents the entry.
Key exclusion criteria
1) Patients who have uncontrollable infections.
2) Patients who have a tendency to bleed in drive-line wound site.
3) Patients who are difficult to close the wound by vacuum assisted closure device.
4) Patients who have an allergy to foam.
5) Patients researchers have determined to be inappropriate.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Minoru |
| Middle name | |
| Last name | Ono |
Organization
Graduate School of Medicine, University of Tokyo
Division name
Department of Cardiac Surgery
Zip code
1138655
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-5800-8855
ONO-THO@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Masaki |
Organization
Graduate School of Medicine, University of Tokyo
Division name
Department of Cardiovascular Medicine
Zip code
1138655
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-5800-8855
Homepage URL
TSUJIM-INT@h.u-tokyo.ac.jp
Sponsor or person
Institute
University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
none
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
Ethics Review Committee, University of Tokyo
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo 113-8655, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2018 | Year | 05 | Month | 02 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/36300650/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36300650/
Number of participants that the trial has enrolled
50
Results
No severe complications were associated with the NPWT. During the follow-up period, DLI was diagnosed in 16 participants (32%) in the NPWT group and 21 participants (42%) in the SD group. The rates of DLI incidence and freedom from DLI did not differ between groups (p = 0.30 and p = 0.63).
Results date posted
| 2023 | Year | 11 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age, BMI, BSA, and history of diabetes mellitus were similar between the two groups. Serum brain natriuretic peptide (BNP) levels were significantly higher in the SD group than those in the NPWT group. The type of LVAD device used was different between the two groups. In the SD group, HeartMate II (Abbott Laboratories, Chicago, IL, USA) was implanted in 22 patients, Jarvik 2000 (Jarvik Heart, New York, NY, USA) in 18 patients, EVAHEART (Sun Medical, Nagano, Japan) in 7 patients, and DuraHeart (Terumo Heart, Ann Arbor, MI, USA) in 3 patients. In the NPWT group, HeartMate II was implanted in 16 patients, HeartMate 3 (Abbott Laboratories, Chicago, IL, USA) in 10 patients, HeartWare HVAD (Medtronic, Minneapolis, MN, USA) in 10 patients, EVAHEART in 11 patients, and Jarvik2000 in 3 patients.
Participant flow
Fifty participants who underwent LVAD implantation between May 2018 and October 2020 were enrolled in the intervention (NPWT) group.
Adverse events
The proportions of cerebrovascular disease and bleeding as LVAD-related complications were similar between the two groups.
Outcome measures
During the follow- up period, DLI was diagnosed in 16 participants (32%) in the NPWT group and 21 participants (42%) in the SD group. The rates of DLI incidence and free-dom from DLI did not differ between groups (p= 0.30 and p= 0.63).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2018 | Year | 05 | Month | 02 | Day |
Last modified on
| 2023 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035980
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