UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Does antimicrobial triclosan-coated PDS PLUS for skin closure reduce surgical site infections? A controlled clinical trial of class II abdominal surgeries.
Title of the study (Brief title)	A controlled clinical trial of antimicrobial triclosan-coated PDS PLUS
Region	Japan

Condition
Condition	class II abdominal surgeries.
Classification by specialty	Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We conduct a controlled clinical trial to examine the effectiveness of PDS PLUS in preventing SSI.
Basic objectives2	Others
Basic objectives -Others	subgroup analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	SSI rate
Key secondary outcomes	risk factors of SSI

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Absorbable monofilament subcutaneous closure
Interventions/Control_2	PDS PLUS subcutaneous closure
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	15 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Class II abdominal surgeries
Key exclusion criteria	General peritonitis, intestinal perforation, prior infectious disease of abdominal cavity
Target sample size	146

Research contact person
Name of lead principal investigator	Umemura Akira
Organization	Morioka Municipal Hospital
Division name	Department of Surgery
Address	5-15-1 Motomiya, Morioka
TEL	019-635-0101
Email	auau001@hotmail.com

Public contact
Name of contact person	Umemura Akira
Organization	Morioka Municipal Hospital
Division name	Department of Surgery
Address	5-15-1 Motomiya, Morioka
TEL	019-635-0101
Homepage URL
Email	auau001@hotmail.com

Sponsor
Institute	Morioka Municipal Hospital
Institute
Department

Funding Source
Organization	Morioka Municipal Hospital
Organization
Division
Category of Funding Organization	Other
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	盛岡市立病院

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 10 Day
Anticipated trial start date	2013 Year 05 Month 10 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	Published
URL releasing results	http://mol.medicalonline.jp/library/journal/download?GoodsID=dg9srgif/2016/001304/003&name=0265-0270
Results
Other related information

Management information
Registered date	2016 Year 04 Month 13 Day
Last modified on	2018 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025218