UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of Subcuticular Suture and Subcutaneous drainage to prevent surgical site infection after hepatobiliary pancreatic surgery
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Hiroaki Nagano
Organization	Osaka University
Division name	Gastroentrological Surgery
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	Maeda Sakae
Organization	Osaka university
Division name	Gastroenterological Surgery
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000013079