UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002927
Receipt No. R000003544
Scientific Title trial of closing wounds by transcutaneus vs subcuticular suture
Date of disclosure of the study information 2010/01/01
Last modified on 2009/12/22

* 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 trial of closing wounds by transcutaneus vs subcuticular suture
Acronym skin closure after operation
Scientific Title trial of closing wounds by transcutaneus vs subcuticular suture
Scientific Title:Acronym skin closure after operation
Region
Japan

Condition
Condition patient undergoing primary total hip/knee arthroplasty
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this trial,we evaluate the needs of transcutaneous suture at wounnd closure of arthroplasty
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes hesistance/bleeding/infection/post operative VAS/Hollander wound evaluation scale/Vancouver scar scale
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 group of subcuticular suture and transcutaneus suture at wound closure
Interventions/Control_2 group of subcuticular suture at wound 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patient underwent arthroplastic surgery of lower limb in our hospital.
Key exclusion criteria patient who were having a peripheral vascular disease,liver dysfunction,poor soft tissue condition,allergy to metal staple.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiji Tensho
Organization Shinshu university school of medicine
Division name Department of Orthopaedic surgery
Zip code
Address Asahi 3-1-1, Matsumoto, Nagano
TEL 0263-37-2659
Email

Public contact
Name of contact person
1st name
Middle name
Last name Keiji Tensho
Organization Shinshu university school of medicine
Division name Department of Orthopaedic surgery
Zip code
Address Asahi 3-1-1, Matsumoto, Nagano
TEL 0263-37-2659
Homepage URL
Email

Sponsor
Institute Shinshu university school of medicine department of Orthopedic surgery
Institute
Department

Funding Source
Organization none
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
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
2010 Year 01 Month 01 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 Preinitiation
Date of protocol fixation
2010 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2010 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
2009 Year 12 Month 22 Day
Last modified on
2009 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003544

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.