UMIN-CTR Clinical Trial

Basic information
Public title	Impact of Subcuticular Suture and Subcutaneous drainage to prevent surgical site infection after hepatobiliary pancreatic surgery
Acronym	Subcuticular Suture and Subcutaneous drainage for hepatobiliary pancreatic surgery
Scientific Title	Impact of Subcuticular Suture and Subcutaneous drainage to prevent surgical site infection after hepatobiliary pancreatic surgery
Scientific Title:Acronym	Subcuticular Suture and Subcutaneous drainage for hepatobiliary pancreatic surgery
Region	Japan

Condition
Condition	Primary liver cancer, metastatic liver cancer, biliary tract cancer, benign liver disease, donor of living donor liver transplantation
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the preventive efficacy of Subcuticular Suture and subcutaneous drainage for surgical site infection after hepatobiliary pancreatic surgery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of incisional surgical site infection
Key secondary outcomes	Rate of wound complication

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Placement of subcutaneous suction drainage and suturing of wound with interrupted subcuticular suture with 3-0 monofilament material
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	1) Hepatobiliary pancreatic surgery, donation of living donor liver transplantation 2) Open surgery case by revers T character incision or reverse L character incision 3)4,000/mm3=<WBC<12,000 /mm3 Neu>=2,000 / mm3 Hb>=9.0 g/dL Plt>=100,000 / mm3 T.Bil=<1.5 mg/dL AST=<100 IU/L ALT=<100 IU/L Creatinin=<1.2 mg/dL Albumin>=2.8 g/dL 4) Written informed consent.
Key exclusion criteria	1) Recipient 2) Emergency 3) Laparoscopic surgery 4) Re-laparotomy 5) Severe infections 6) Bleeding tendency or coagulation disorders 7) Uncontrolled diabetes mellitus 8) Psychic disorder 9) Severe heart or lung diseases 10) Continuous use of steroids
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroaki Nagano
Organization	Osaka University
Division name	Gastroentrological Surgery
Zip code
Address	2-2 Yamadaoka Suita, Osaka, Japan
TEL	06-6879-3251
Email	hnagano@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Maeda Sakae
Organization	Osaka university
Division name	Gastroenterological Surgery
Zip code
Address	2-2 Yamadaoka Suita, Osaka, Japan
TEL	06-6879-3251
Homepage URL
Email	smaeda@geusrg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University, Gastroenterological Surgery
Institute
Department

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	YES
Study ID_1	13092
Org. issuing International ID_1	Clinical Trial Center of Osaka University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	大阪大学医学部附属病院　（大阪府）

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 03 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	2013 Year 09 Month 24 Day
Date of IRB
Anticipated trial start date	2013 Year 10 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 10 Month 02 Day
Last modified on	2016 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013079

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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