UMIN-CTR Clinical Trial

Basic information
Public title	The effect of surgical instrument exchange at closed wound on the Prevention of surgical site Infection in contaminated surgery of the lower gastrointestinal surgery
Acronym	The effect of surgical instrument exchange at closed wound on the Prevention of surgical site Infection in contaminated surgery of the lower gastrointestinal surgery
Scientific Title	The effect of surgical instrument exchange at closed wound on the Prevention of surgical site Infection in contaminated surgery of the lower gastrointestinal surgery
Scientific Title:Acronym	The effect of surgical instrument exchange at closed wound on the Prevention of surgical site Infection in contaminated surgery of the lower gastrointestinal surgery
Region	Japan

Condition
Condition	lower gastrointestinal surgery
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to clarify the effect of instrument exchange at the time of wound closure on the prevention of wound infection in contaminated surgery of the lower gastrointestinal surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incisional surgical site infection rate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Changing surgical instrument at the time ofwound closure
Interventions/Control_2	not changing surgical instrument at the time ofwound closure
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	lower gastrointestinal surgery
Key exclusion criteria	laparoscopic surgery
Target sample size	180

Research contact person
Name of lead principal investigator	1st name hiroki Middle name Last name ikeuchi
Organization	Hyogo college of medicine
Division name	gastointestinal surgery
Zip code	663-8501
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL	0798-45-6372
Email	ikeuci2s@hyo-med.ac.jp

Public contact
Name of contact person	1st name Ryuichi Middle name Last name Kuwahara
Organization	Hyogo college of medicine
Division name	gastointestinal surgery
Zip code	663-8501
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL	0798-45-6372
Homepage URL
Email	ri-kuwahara@hyo-med.ac.jp

Sponsor
Institute	Hyogo college of medicine
Institute
Department

Funding Source
Organization	Hyogo college of medicine
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	Hyogo college of medicine
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo
Tel	0798456372
Email	rinri@hyo-med.ac.jp

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	2021 Year 04 Month 01 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	Main results already published
Date of protocol fixation	2021 Year 04 Month 01 Day
Date of IRB	2021 Year 05 Month 24 Day
Anticipated trial start date	2021 Year 05 Month 24 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 03 Month 09 Day
Last modified on	2022 Year 08 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049742