UMIN-CTR Clinical Trial

Basic information
Public title	Incidence of surgical site infections in abdominal wound closure techniques with skin staple versus buried subcuticular suture for gastrointestinal, abdominal vascular, hepatobiliary and pancreatic surgery: an unblinded randomized controlled trial.
Acronym	Incidence of surgical site infections in abdominal wound closure techniques with skin staple versus buried subcuticular suture for gastrointestinal, abdominal vascular, hepatobiliary and pancreatic surgery: an unblinded randomized controlled trial.
Scientific Title	Incidence of surgical site infections in abdominal wound closure techniques with skin staple versus buried subcuticular suture for gastrointestinal, abdominal vascular, hepatobiliary and pancreatic surgery: an unblinded randomized controlled trial.
Scientific Title:Acronym	Incidence of surgical site infections in abdominal wound closure techniques with skin staple versus buried subcuticular suture for gastrointestinal, abdominal vascular, hepatobiliary and pancreatic surgery: an unblinded randomized controlled trial.
Region	Japan

Condition
Condition	Cases undergoing gastrointestinal, abdominal vascular, hepatobiliary and pancreatic open surgery.
Classification by specialty	Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Testing the hypothesis that incidence of surgical site infection in abdominal wound closure is significant less with buried subcuticular suture than skin staple
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	rate of superficial surgical site infection
Key secondary outcomes	rate of deep surgical site infection,hospitalization after surgery,hospitalization cost

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Abdominal wound closure with buried subcuticular suture.
Interventions/Control_2	Abdominal wound closure with skin staple.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Cases undergoing gastrointestinal, abdominal vascular, hepatobiliary and pancreatic open surgery.
Key exclusion criteria	laparoscopic surgery,repair of hernia, only colostomy or ileostomy
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuhiro Imamura
Organization	Tokyo Metropolitan Tama Medical center
Division name	department of surgery
Zip code
Address	2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
TEL	042-323-5111
Email

Public contact
Name of contact person	1st name Middle name Last name Kazuhiro Imamura
Organization	Tokyo Metropolitan Tama Medical center
Division name	department of surgery
Zip code
Address
TEL	042-323-5111
Homepage URL
Email

Sponsor
Institute	Tokyo Metropolitan Tama Medical center
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization	Local Government
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	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	2011 Year 01 Month 07 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	2010 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date	2011 Year 01 Month 01 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	2011 Year 01 Month 07 Day
Last modified on	2020 Year 08 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005759