UMIN-CTR Clinical Trial

Basic information
Public title	Investigating the tissue migration of anti-MRSA drugs in soft tissue infections
Acronym	Investigating the tissue migration of anti-MRSA drugs in soft tissue infections
Scientific Title	Investigating the tissue migration of anti-MRSA drugs in soft tissue infections
Scientific Title:Acronym	Investigating the tissue migration of anti-MRSA drugs in soft tissue infections
Region	Japan

Condition
Condition	Pressure ulcer in sacral and ischial region which have been performed flap reconstruction.
Classification by specialty	Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We compare the concentration of the anti MRSA medicine in the tissue fluid and the blood. We Investigate the tissue migration of anti-MRSA drugs in soft tissue infections
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The concentration of the anti MRSA medicine in the tissue fluid, the blood plasma and tissue transitivity of the medicine, We compare the concentration using the fluid in the drainage bag and the data of blood test until 3days post operation date.
Key secondary outcomes

Base
Study type	Observational

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	15 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	A total of 60 patients with bed sores who were eligible for flap formation and were infected or colonized by MRSA (patients receiving vancomycin, n = 20; those receiving daptomycin, n = 20; and those receiving linezolid, n = 20) were enrolled.
Key exclusion criteria	Patients aged under 15 years or over 100 years.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Tomoya Middle name Last name Sato
Organization	Saitama Medical University Hospital
Division name	Plastic and Reconstructive surgery department
Zip code	3500495
Address	38 Morohongo, Moroyama, Iruma-Gun, Saitama prefecture, Japan
TEL	0492761230
Email	tsato11032@yahoo.co.jp

Public contact
Name of contact person	1st name Tomoya Middle name Last name Sato
Organization	Saitama Medical University Hospital
Division name	Plastic and Reconstructive surgery department
Zip code	3500495
Address	38 Morohongo, Moroyama, Iruma-Gun, Saitama prefecture, Japan
TEL	0492761230
Homepage URL
Email	tsato11032@yahoo.co.jp

Sponsor
Institute	Saitama Medical University Hospital
Institute
Department

Funding Source
Organization	Saitama Medical University Hospital
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	IRB executive office of Saitama Medical University hospital
Address	38 Morohongo, Moroyama, Iruma-Gun, Saitama prefecture, Japan
Tel	0492761354
Email	hirb@saitama-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	2019 Year 06 Month 04 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	No longer recruiting
Date of protocol fixation	2019 Year 02 Month 25 Day
Date of IRB	2019 Year 07 Month 08 Day
Anticipated trial start date	2019 Year 07 Month 31 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

1. Sample collection A subcutaneous drain was placed during surgery. Patients received an anti- MRSA drug (vancomycin, daptomycin, or linezolid) 30 min before the surgery and at 9 o'clock from the following day onward. A drainage sample (10ml) was collected on the day after surgery. 2. Determination of drug concentrations The ratio of anti- MRSA drug concentrations in blood and drainage samples was calculated to determine the tissue migration of the drugs. Drug concentrations were determined using a liquid chromatography- tandem spectrometer (LC-MS/ MS).

Management information
Registered date	2019 Year 06 Month 03 Day
Last modified on	2022 Year 06 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041931