UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003874
Receipt number R000004661
Scientific Title Study of the efficacy of antibacterial suture for surgical site infection: a retrospective controlled trial
Date of disclosure of the study information 2010/07/12
Last modified on 2012/01/06 09:56:31

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Basic information

Public title

Study of the efficacy of antibacterial suture for surgical site infection: a retrospective controlled trial

Acronym

Study of the efficacy of antibacterial suture for surgical site infection

Scientific Title

Study of the efficacy of antibacterial suture for surgical site infection: a retrospective controlled trial

Scientific Title:Acronym

Study of the efficacy of antibacterial suture for surgical site infection

Region

Japan


Condition

Condition

The case of digestive surgery

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We retrospectively investigate triclosan-coated sutures for the closure of abdominal incision decrease surgical site infection compared with absorbable surgical suture Coated VICRYL.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The incidence of surgical site infection

Key secondary outcomes

Hospital stay after surgery


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

Over twenty years old
The case of gastroenterological surgery include emergency

Key exclusion criteria

The case who assessed as inadequasy

Target sample size

645


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuichi Yamashita

Organization

Fukuoka University School of Medicine

Division name

Department of Gastroenterological Surgery

Zip code


Address

7-45-1,Nanakuma, Jonan-ku,Fukuoka

TEL

092-801-1011

Email



Public contact

Name of contact person

1st name
Middle name
Last name Seiichiro Hoshino

Organization

Fukuoka University School of Medicine

Division name

Gastroenterological Surgery

Zip code


Address

7-45-1,Nanakuma, Jonan-ku,Fukuoka

TEL

092-801-1011

Homepage URL


Email

shoshino@fukuoka-u.ac.jp


Sponsor or person

Institute

Gastroenterological Surgery,
Fukuoka University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

福岡大学病院(福岡県)


Other administrative information

Date of disclosure of the study information

2010 Year 07 Month 12 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

Preinitiation

Date of protocol fixation

2010 Year 07 Month 05 Day

Date of IRB


Anticipated trial start date

2010 Year 07 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

The incidence of surgical site infection
Hospital stay after surgery


Management information

Registered date

2010 Year 07 Month 06 Day

Last modified on

2012 Year 01 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004661


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name