UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011307 |
|---|---|
| Receipt number | R000013211 |
| Scientific Title | An evaluation of different suturing techniques using V-Loc180 in subcutaneous suture: Continuous vertical suture or Continuous horizontal suture ? |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2019/02/01 10:42:02 |
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Basic information
Public title
An evaluation of different suturing techniques using V-Loc180 in subcutaneous suture: Continuous vertical suture or Continuous horizontal suture ?
Acronym
An evaluation of different suturing techniques using V-Loc180 in subcutaneous suture: Continuous vertical suture or Continuous horizontal suture ?
Scientific Title
An evaluation of different suturing techniques using V-Loc180 in subcutaneous suture: Continuous vertical suture or Continuous horizontal suture ?
Scientific Title:Acronym
An evaluation of different suturing techniques using V-Loc180 in subcutaneous suture: Continuous vertical suture or Continuous horizontal suture ?
Region
| Japan |
Condition
Condition
Patients who will receive a bilaterally symmetrical cut wound longer than or equal to 20 cm long on the trunk.
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Two different suturing techniques using the suture thread, V-Loc180, will be evaluated. In patients with a bilaterally symmetrical cut wound longer than or equal to 20 cm long on the trunk, half of the wound will be closed with continuous vertical sutures and the other half with continuous horizontal sutures, and the results of the suturing techniques will be compared.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
VSS (Vancouver Scar Scale)
Key secondary outcomes
1) POSAS (The Patient and Observer Scar Assessment Scale)
2) Operating time
3) Time needed to complete suturing
4) Length and number of suture threads used for suturing
5) Complications
6) Malfunctions
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In patients with a bilaterally symmetrical cut wound longer than or equal to 20cm long on the trunk, continuous vertical sutures will be applied to half of the wound.
Interventions/Control_2
Continuous horizontal sutures will be applied to the other half.
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
1) Patients who will receive a bilaterally symmetrical cut wound longer than or equal to 20 cm long on the trunk
2) Patients with an Eastern Cooperative Oncology Group Scale of Performance Status (ECOG) of either 0 or 1
3) Patients with sufficient function of the major organs
4) Written informed consent to participate in the trial must be obtained from the patient him/herself (those of 20 years or older) or the guardians (those under 20 years old).
Key exclusion criteria
1) Patients with past traumatic injury at the suture site
2) Patients with an active bacterial or fungal infection
3) Patients with poorly controlled diabetes mellitus (HbA1C>8.0)
4) Patients with psychiatric disorders or symptoms and for whom it is judged difficult to participate in the trial
5) Patients who are allergic to nickel chrome
6) Patients who are otherwise judged unsuitable to participate in the trial by the investigator
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ohjimi |
Organization
School of Medicine, Fukuoka University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL
092-801-1011
ohjimi@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Kawakami |
Organization
School of Medicine, Fukuoka University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL
092-801-1011
Homepage URL
kawaprs@fukuoka-u.ac.jp
Sponsor or person
Institute
Department of Plastic and Reconstructive Surgery, School of Medicine, Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Covidien Japan Inc.
Organization
Division
Category of Funding Organization
Profit organization
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
福岡大学病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | 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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 29 | Day |
Last modified on
| 2019 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013211
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