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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003360
Receipt No. R000004047
Scientific Title A multicenter study to investigate characteristics of bacterial wound contamination in clean orthopaedic surgeries
Date of disclosure of the study information 2010/03/19
Last modified on 2010/10/25

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Basic information
Public title A multicenter study to investigate characteristics of bacterial wound contamination in clean orthopaedic surgeries
Acronym Characteristics of bacterial wound contamination in clean orthopaedic surgeries
Scientific Title A multicenter study to investigate characteristics of bacterial wound contamination in clean orthopaedic surgeries
Scientific Title:Acronym Characteristics of bacterial wound contamination in clean orthopaedic surgeries
Region
Japan

Condition
Condition Clean Orthopaedic Surgeries
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the incidence and the characteristics of bacterial wound contamination during clean orthopaedic surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of bacterial wound contamination increases after normal saline irrigation in clean orthopaedic surgeries.
Key secondary outcomes (1)Characteristics of the isolated bacteria.
(2)Incidence of MRSA contamination.
(3)Risk factors of bacterial wound contamination.

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Consecutive patients undergoing open reduction and internal fixation of closed fractures(ORIF), spinal surgeries, and joint surgeries in 5 hospitals.
Key exclusion criteria 1)patients who had received any anti-microbial agents during the week before surgery,
2)surgery involving the infected site,
3)patients with skin trouble in surgical site,
4)hand surgery,
5)foot surgery,
6)arthroscopic surgery,
7)patients with renal failure (serum creatinine level of more than 1.5 microgram/dl at admission),
8)patients receiving hemodialysis,
9)operation longer than 6 hours,
10)open fracture,
11)nonunion,
12)peripheral nerve surgery,
13)tuberculous spondylitis,
14)antimicrobial prophylaxis other than cefazolin,
15)re-operation,
16)external fixation,
17)percutaneous pinning,
18)patients who are pregnant,
19)patients less than 20 years old,
20)patients with allergy to the beta-lactam antibiotics,
21)patients of iodine hypersensitivity,
22)patients receiving multiple operations in the same day,
23)intraoperative radiotherapy
24)operation with unexpected dirty procedures.
Target sample size 700

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsurou Karita
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of Orthopaedic Surgery
Zip code
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo, 183-8524, Japan
TEL 042-323-5111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Iga Toru
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of Orthopaedic Surgery
Zip code
Address
TEL 042-323-5111
Homepage URL
Email

Sponsor
Institute Surgical Site Infection Prevention Project(SSIPP) workgroup meeting
Institute
Department

Funding Source
Organization Office of Metropolitan Hospital Management
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 多摩総合医療センター(東京都)、東京都立墨東病院(東京都)、東京都立駒込病院(東京都)、東京都立広尾病院(東京都)、多摩北部医療センター(東京都)
Department of Orthopaedic Surgery,Tokyo Metropolitan Tama Medical Center, Tokyo, Japan
Department of Orthopaedic Surgery,Tokyo Metropolitan Bokutoh Hospital, Tokyo, Japan
Department of Orthopaedic Surgery,Tokyo Metropolitan Hiroo Hospital, Tokyo, Japan
Department of Orthopaedic Surgery,Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Tokyo, Japan
Department of Orthopaedic Surgery, Tama-Hokubu Medical Center, Tokyo, Japan

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 19 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
2009 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Incidence of bacterial wound contamination, characteristics of the isolated bacteria, and risk factors of bacterial wound contamination will be analyzed.


Management information
Registered date
2010 Year 03 Month 19 Day
Last modified on
2010 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004047

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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