UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An evaluation of different suturing techniques using V-Loc180 in subcutaneous suture: Continuous vertical suture or Continuous horizontal suture ?
Title of the study (Brief title)	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	Hiroyuki Ohjimi
Organization	School of Medicine, Fukuoka University
Division name	Department of Plastic and Reconstructive Surgery
Address	7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL	092-801-1011
Email	ohjimi@fukuoka-u.ac.jp

Public contact
Name of contact person	Yoshihisa Kawakami
Organization	School of Medicine, Fukuoka University
Division name	Department of Plastic and Reconstructive Surgery
Address	7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL	092-801-1011
Homepage URL
Email	kawaprs@fukuoka-u.ac.jp

Sponsor
Institute	Department of Plastic and Reconstructive Surgery, School of Medicine, Fukuoka University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013211