UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018231
Receipt number R000021103
Scientific Title Evaluation about safety and the effectiveness of the povidone iodine applicator once sterilization in the abdominal surgery
Date of disclosure of the study information 2015/07/13
Last modified on 2017/09/18 01:04:32

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Basic information

Public title

Evaluation about safety and the effectiveness of the povidone iodine applicator once sterilization in the abdominal surgery

Acronym

Evaluation about safety and the effectiveness of the povidone iodine applicator once sterilization in the abdominal surgery

Scientific Title

Evaluation about safety and the effectiveness of the povidone iodine applicator once sterilization in the abdominal surgery

Scientific Title:Acronym

Evaluation about safety and the effectiveness of the povidone iodine applicator once sterilization in the abdominal surgery

Region

Japan


Condition

Condition

Disease of abdominal surgery

Classification by specialty

Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We inspect the difference with povidone iodine applicator sterilization and the existing sterilization method and evaluate the safety and effectiveness.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Wound infection rate

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

We sterilize their skin using a povidone iodine applicator for preoperative skin sterilization.

Interventions/Control_2

We sterilize their skin using povidone iodine 10% antiseptic solution and a cotton balls for preoperative skin sterilization.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

・Planned abdominal surgery patient except the patient meeting an exclusion item.
・Written informed consent.

Key exclusion criteria

・The following operation patient.
1 Operations with perineum operation such as the art of abdominoperineal resection of rectum.
2 Operations of the artificial anus enlargement plan.
3 Operations with the artificial anus at the time of the performance of an operation such as the art of artificial anus closedown.
4 Robot-assisted operations.
5 Cancer of the esophagus operation.
6 Groin hernia operation.
・Patient of the anamnesis of hypersensitivity in iododisinfectant.

Target sample size

600


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhiro Hiramatsu

Organization

Toyohashi Municipal Hospital

Division name

general surgery

Zip code


Address

50 Hakken nishi, Aotakecho, Toyohashi, Aichi

TEL

0532-33-6111

Email

hiramatsu-kazuhiro@toyohashi-mh.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuichi Kambara

Organization

Toyohashi Municipal Hospital

Division name

general surgery

Zip code


Address

50 Hakken nishi, Aotakecho, Toyohashi, Aichi

TEL

0532-33-6111

Homepage URL


Email

kanbara-yuichi@toyohashi-mh.jp


Sponsor or person

Institute

Toyohashi Municipal Hospital

Institute

Department

Personal name



Funding Source

Organization

Toyohashi Municipal Hospital

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



Other administrative information

Date of disclosure of the study information

2015 Year 07 Month 13 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

Completed

Date of protocol fixation

2015 Year 04 Month 06 Day

Date of IRB


Anticipated trial start date

2015 Year 04 Month 13 Day

Last follow-up date

2017 Year 10 Month 15 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 07 Month 07 Day

Last modified on

2017 Year 09 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021103


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name