UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039546 |
|---|---|
| Receipt number | R000045010 |
| Scientific Title | Development of Surgical site infection prevention method with platelet rich plasma (PRP) |
| Date of disclosure of the study information | 2020/02/21 |
| Last modified on | 2022/03/03 18:47:38 |
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Basic information
Public title
Development of surgical site infection prevention with platelet rich plasma
Acronym
SSI prevention with PRP
Scientific Title
Development of Surgical site infection prevention method with platelet rich plasma (PRP)
Scientific Title:Acronym
SSI prevention with PRP
Region
| Japan |
Condition
Condition
Surgical site infection
Classification by specialty
| Infectious disease | Orthopedics | Cardiovascular surgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aim of this study is to clarify the anti-bacterial and anti-fungal spectrum of PRP. This is the in vitro study, using the clinically isolated bacteria and fungi, including multi-drug resistant strains. These strains are selected based on the frequency isolated in class-1 clean surgery, e.g. cardio vascular and artificial joint implantation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To quantify the anti-bacterial activity to bacteria, which is frequently isolated in SSI and DSWI cases in Japan.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Healthy male subjects at age between 20 and 60 upon consent
2.Subjects who can come to collect blood in the morning of the day to conduct the study.
3.Subjects who gives written agreement to the informed consent.
Key exclusion criteria
Volunteer who comes under any of below conditions are excluded from the study.
1.Subject who has smoking habits
2.Subject who has any blood disease (cancer, anemia, etc) or blood born transmitted disease (hepatitis virus infection)
3.Subject who was prescribed with anti-coagulant (warfarin) or anti-platelet (aspirin) drug
4.Subject who has allergy to alcohol
5.Subject who is rejected by researcher
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Ohge |
Organization
Hiroshima University Hospital
Division name
Department of Infectious Diseases
Zip code
734-8551
Address
1-2-3 Kasumi, Minamiku, Hiroshima 734-8551, Japan
TEL
082-257-1613
ohge@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Tanaka |
Organization
Hiroshima University Hospital
Division name
Department of Infectious Diseases
Zip code
734-8551
Address
1-2-3 Kasumi, Minamiku, Hiroshima 734-8551, Japan
TEL
082-257-1613
Homepage URL
kansen@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
TERUMO BCT Japan, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
EthicalCommittee for Clinical Research of HiroshimaUniversity
Address
1-2-3 Kasumi, Minamiku, Hiroshima 734-8551, Japan
Tel
082-257-1551
iryo-seisaku@office.hiroshima-u.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
| 2020 | Year | 02 | Month | 21 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
* Observe the subjects carefully after donation for the adversed events
* Observe the blood cells configuration (hematocrit, WBC, RBC, and PLT) to confirm the subjects are healthy. Observe the same in prepared PRP to confirm the PLT is appropriately concentrated.
* Aliquot of peripheral plasma and PRP are kept in frozen, and some growth factors are measured on necessary bases.
Management information
Registered date
| 2020 | Year | 02 | Month | 20 | Day |
Last modified on
| 2022 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045010
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
