UMIN-CTR Clinical Trial

Basic information
Public title	The effect of changing of surgical instruments on postoperative wound infection for intestinal surgery of wound classification 3 or higher
Acronym	The effect of changing of surgical instruments on postoperative wound infection for intestinal surgery of wound classification 3 or higher
Scientific Title	The effect of changing of surgical instruments on postoperative wound infection for intestinal surgery of wound classification 3 or higher
Scientific Title:Acronym	The effect of changing of surgical instruments on postoperative wound infection for intestinal surgery of wound classification 3 or higher
Region	Japan

Condition
Condition	Lower gastrointestinal surgery
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	SSI in gastrointestinal surgery is an important complication.Currently, our hospital uses a closed wound surgical insturament, but there is no clear evidence of the impact of the wound on SSI after surgery. We examined the influence of the use of the wound closure surgical insturament on postoperative wound infection of the lower gastrointestinal surgery of wound classification 3 or higher
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Infection rate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Changing of surgical instruments
Interventions/Control_2	Not Changed the insutrament for wound close
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	Lower gastrointestinal surgery performed in our department
Key exclusion criteria	other than that
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Ryuichi Middle name Last name Kuwahara
Organization	Hyogo College of Medicine
Division name	Inflammatory bowel disease surgery
Zip code	6638501
Address	1-1 Mukogawa-cho, Nishinomiya City, Hyogo Prefecture
TEL	0798456372
Email	kuwahararyuichi@yahoo.co.jp

Public contact
Name of contact person	1st name Ryuichi Middle name Last name Kuwahara
Organization	Hyogo College of Medicine
Division name	Inflammatory bowel disease surgery
Zip code	6638501
Address	1-1 Mukogawa-cho, Nishinomiya City, Hyogo Prefecture
TEL	0798456372
Homepage URL
Email	kuwahararyuichi@yahoo.co.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Hyogo College of Medicine
Organization
Division
Category of Funding Organization	Other
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 City, Hyogo Prefecture
Tel	0798456372
Email	kuwahararyuichi@yahoo.co.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	2019 Year 08 Month 08 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	2019 Year 08 Month 08 Day
Date of IRB	2017 Year 11 Month 14 Day
Anticipated trial start date	2019 Year 08 Month 08 Day
Last follow-up date	2023 Year 12 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	2019 Year 08 Month 07 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=R000042898