UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048169 |
|---|---|
| Receipt number | R000053972 |
| Scientific Title | Investigation of the usefulness of a novel skin-closing device in gastrointestinal surgery: a multicenter randomized controlled trial |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2022/12/27 10:32:33 |
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Basic information
Public title
Investigation of the usefulness of a novel skin-closing device in gastrointestinal surgery: a multicenter randomized controlled trial
Acronym
Investigation of the usefulness of a novel skin-closing device.
Scientific Title
Investigation of the usefulness of a novel skin-closing device in gastrointestinal surgery: a multicenter randomized controlled trial
Scientific Title:Acronym
Investigation of the usefulness of a novel skin-closing device.
Region
| Japan |
Condition
Condition
Malignant or benign diseases of the digestive system requiring an open abdominal wound of 4 cm or greater
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In abdominal surgery, as in other fields, skin closure using the Zipline reduces postoperative SSI, is superior in cosmesis, and contributes to shorter operative time.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time required for skin closure
Key secondary outcomes
Incidence of complications (wound infection, wound dehiscence) within 1 month after surgery, and wound cosmesis 6 months after surgery
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Skin closure with Zipline
Interventions/Control_2
Skin closure with interrupted 4-0 monofilament absorbalbe suture.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following eligibility criteria will be considered eligible
(1) Patients with malignant or benign diseases of the gastrointestinal system who undergo standby laparotomy with a laparotomy wound of 4 cm or larger.
(2) Patients must be at least 20 years of age at the time of consent.
(3) The patient himself/herself must be informed of the procedure using a written explanation and his/her written consent must be obtained.
Key exclusion criteria
Exclude cases that fall into any of the following categories
(1)Emergency surgery
(2)Pregnancy
(3)Cases with serious infections.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Itano |
Organization
International University of Health and Welfare, School of Medicine
Division name
Department of Hepato-Biliary-Pancreatic and Gastrointestinal Surgery
Zip code
286-8520
Address
852 Hatakeda, Narita, Chiba
TEL
0476-35-5600
itano@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Minagawa |
Organization
International University of Health and Welfare, School of Medicine
Division name
Department of Hepato-Biliary-Pancreatic and Gastrointestinal Surgery
Zip code
286-8520
Address
852 Hatakeda, Narita, Chiba
TEL
0476-35-5600
Homepage URL
minagawa@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare.
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
Institutional review board, International University of Health and Welfare
Address
852 Hatakeda, Narita, Chiba
Tel
0476-35-5600
rinri_md@iuhw.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
| 2022 | Year | 07 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 26 | Day |
Last modified on
| 2022 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053972
