UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003360
Receipt number 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 09:28:10

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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 or person

Institute

Surgical Site Infection Prevention Project(SSIPP) workgroup meeting

Institute

Department

Personal name



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

Value
https://center6.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