UMIN-CTR Clinical Trial

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
Email	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
Email	kansen@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045010