UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021892 |
|---|---|
| Receipt number | R000025218 |
| Scientific Title | Does antimicrobial triclosan-coated PDS PLUS for skin closure reduce surgical site infections? A controlled clinical trial of class II abdominal surgeries. |
| Date of disclosure of the study information | 2016/04/20 |
| Last modified on | 2018/08/21 10:57:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Does antimicrobial triclosan-coated PDS PLUS for skin closure reduce surgical site infections? A controlled clinical trial of class II abdominal surgeries.
Acronym
A controlled clinical trial of antimicrobial triclosan-coated PDS PLUS
Scientific Title
Does antimicrobial triclosan-coated PDS PLUS for skin closure reduce surgical site infections? A controlled clinical trial of class II abdominal surgeries.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Umemura Akira |
Organization
Morioka Municipal Hospital
Division name
Department of Surgery
Zip code
Address
5-15-1 Motomiya, Morioka
TEL
019-635-0101
auau001@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Umemura Akira |
Organization
Morioka Municipal Hospital
Division name
Department of Surgery
Zip code
Address
5-15-1 Motomiya, Morioka
TEL
019-635-0101
Homepage URL
auau001@hotmail.com
Sponsor or person
Institute
Morioka Municipal Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://mol.medicalonline.jp/library/journal/download?GoodsID=dg9srgif/2016/001304/003&name=0265-0270
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
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 10 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025218
