UMIN-CTR Clinical Trial

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

Clean Orthopaedic Surgeries

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Surgical Site Infection Prevention Project(SSIPP) workgroup meeting

Institute

Department

Personal name

Organization

Office of Metropolitan Hospital Management

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2010

Year

03

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

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

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