UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000036670
Receipt No. R000041785
Scientific Title A randomized analysis for subcuticular sutures versus staples for skin closure after liver resection
Date of disclosure of the study information 2019/05/08
Last modified on 2020/11/07 (Ver. 3)

* 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 A randomized analysis for subcuticular sutures versus staples for skin closure after liver resection
Acronym Methods for skin closure after liver resection
Scientific Title A randomized analysis for subcuticular sutures versus staples for skin closure after liver resection
Scientific Title:Acronym RCT for skin closure after liver resection
Region
Japan

Condition
Condition Require for liver resection
Classification by specialty
Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Subcuticular sutures is known as a prefer for infectious complication after surgery. We planned to assess the infection rate between subcuticular sutures and staples for skin closure after liver resection.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Infectious complication of the surgical wound.
Key secondary outcomes total infection rate, terms of administration and total medical cost

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Subcuticular sutures
Interventions/Control_2 staples for skin 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
20 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria 1) Require liver resection
2) entire treatment case
3) no other other resection but for gull bladder
4) EGOG PS 0-2
5) No co-morbidity for operation
6) Enough liver functional reserve
7) more than 20Y
Key exclusion criteria 1) No other abdominal surgery within 1 month.
2) No OMI or unstable angina within 6 month.
3) No idiopathic pneumonia or severe fibrosis of lung
4) Allergic reaction for operation materials
5) Stable psychologic status
6) Under pregnancy
7) Emergency operation
8) judged as "no inclusion" by the treatment doctors
Target sample size 530

Research contact person
Name of lead principal investigator
1st name SHINTARO
Middle name
Last name YAMAZAKI
Organization Nihon university school of medicine
Division name Digestive surgery
Zip code 1738610
Address 30-1 Ohyaguchkamicho Itabashiku Tokyo Japan
TEL 0339728111
Email yamazaki-nmed@umin.ac.jp

Public contact
Name of contact person
1st name SHINTARO
Middle name
Last name YAMAZAKI
Organization Nihon university school of medicine
Division name Digestive surgery
Zip code 1738610
Address 30-1 Ohyaguchkamicho Itabashiku Tokyo Japan
TEL 0339728111
Homepage URL
Email yamazaki-nmed@umin.ac.jp

Sponsor
Institute Nihon university school of medicine
Institute
Department

Funding Source
Organization No funding in this study
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nihon university school of medicine
Address 30-1 Ohyaguchkamicho Itabashiku Tokyo Japan
Tel 0339728111
Email yamazaki-nmed@umin.ac.jp

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
2019 Year 05 Month 08 Day

Related information
URL releasing protocol none
Publication of results Partially published

Result
URL related to results and publications none
Number of participants that the trial has enrolled 560
Results 
As the primary outcome, the wound complication rate did not differ significantly. As the secondary endpoint the wound complication rate in repeat resection significantly less frequent in subcuticular suture.
Results date posted
2020 Year 05 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
common liver resection without biliary reconstruction.
Participant flow 
Of the 581 enrolled patients, 281 patients with subcuticular sutures and 283 patients with staples were analysed.
Adverse events 
None
Outcome measures 
Primary: total wound complication.
Secondary: wound complication in repeat resection.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 12 Month 15 Day
Date of IRB
2017 Year 02 Month 15 Day
Anticipated trial start date
2017 Year 02 Month 16 Day
Last follow-up date
2019 Year 02 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 08 Day
Last modified on
2020 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041785