UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of efficacy of negative pressure wound therapy for surgical site infection after hepatobiliary and pancreatic surgery
Title of the study (Brief title)	Prospective study of efficacy of negative pressure wound therapy for surgical site infection after hepatobiliary and pancreatic surgery
Region	Japan

Condition
Condition	Surgical site infection
Classification by specialty	Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the efficacy of negative pressure wound therapy for surgical site infection after hepatobiliary and pancreatic surgery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The duration from incidence of surgical site infection to wound healing
Key secondary outcomes	The postoperative hospital stay, the cost of hospitalization, the presence of reopened wound, the presence and degree of adverse events

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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	For the patients with surgical site infection after hepatobiliary and pancreatic surgery, unroofing and debridement of infected wound is performed. Therefore, negative pressure wound therapy is started and continued for 1-2 weeks. After recognizing a formation of wound granulation, the wound is closed by suture.
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, The patients with surgical site infection after hepatobiliary and pancreatic surgery 2, Older than 20 years old 3, ECOG performance status of 0 to 2 4, Estimated survival is over 6 months 5, Documented informed consent
Key exclusion criteria	1, Naked blood vessel suspected of bleeding or surgical site infection to directly contact to other organs or the presence of fistula to abdominal cavity. 2, The presence of organ/space surgical site infection 3, As determined by the principal investigator or the sub-investigator the subject is not adequate to participate in the study.
Target sample size	70

Research contact person
Name of lead principal investigator	Hidetoshi Eguchi
Organization	Osaka University, Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Address	2-2 Yamadaoka, Suita, Osaka, Japan
TEL	+81-6-6879-3251
Email	heguchi@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	Takehiro Noda
Organization	Osaka University, Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Address	2-2 Yamadaoka, Suita, Osaka, Japan
TEL	+81-6-6879-3251
Homepage URL
Email	tnoda@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Multicenter Clinical Study Group of Osaka
Institute
Department

Funding Source
Organization	Osaka University, Graduate School of Medicine Department of Gastroenterological Surgery
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	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 06 Month 25 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 06 Month 11 Day
Anticipated trial start date	2015 Year 06 Month 11 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	2015 Year 06 Month 24 Day
Last modified on	2017 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020906