UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study of efficacy of negative pressure wound therapy for open wound after contaminated abdominal surgery and surgical site infection after gastrointestinal surgery
Acronym	Prospective study of efficacy of negative pressure wound therapy for open wound after contaminated abdominal surgery and surgical site infection after gastrointestinal surgery
Scientific Title	Prospective study of efficacy of negative pressure wound therapy for open wound after contaminated abdominal surgery and surgical site infection after gastrointestinal surgery
Scientific Title:Acronym	Prospective study of efficacy of negative pressure wound therapy for open wound after contaminated abdominal surgery and surgical site infection after gastrointestinal surgery
Region	Japan

Condition
Condition	Surgical site infection
Classification by specialty	Surgery in general Gastrointestinal surgery 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 open wound after contaminated abdominal surgery and surgical site infection after gastrointestinal 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 open wound after contaminated abdominal surgery and surgical site infection after gastrointestinal 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 contaminated abdominal surgery and surgical site infection after gastrointestinal surgery 2, Older than 20 years old 3, ECOG performance status of 0 to 2 4, 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	1st name Junzo Middle name Last name Shimizu
Organization	Toyonaka Municipal Hospital
Division name	Department of Surgery
Zip code	560-8565
Address	4-1-1 Shibahara, Toyonaka, Osaka, Japan
TEL	+81-6-6843-0101
Email	ai.npwt.organizer@gmail.com

Public contact
Name of contact person	1st name Kozo Middle name Last name Noguchi
Organization	Toyonaka Municipal Hospital
Division name	Department of Surgery
Zip code	560-8565
Address	4-1-1 Shibahara, Toyonaka, Osaka, Japan
TEL	+81-6-6843-0101
Homepage URL
Email	ai.npwt.organizer@gmail.com

Sponsor
Institute	Clinical study group of AI-NPWT
Institute
Department

Funding Source
Organization	Clinical study group of AI-NPWT
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	Toyonaka Municipal Hospital
Address	4-1-1 Shibahara, Toyonaka, Osaka, Japan
Tel	+81-6-6843-0101
Email	rinsyoukenkyuu@city.toyonaka.osaka.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 09 Month 13 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 04 Month 02 Day
Date of IRB	2019 Year 06 Month 24 Day
Anticipated trial start date	2019 Year 06 Month 24 Day
Last follow-up date	2021 Year 07 Month 24 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 09 Month 12 Day
Last modified on	2021 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043314