UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040293 |
|---|---|
| Receipt number | R000045940 |
| Scientific Title | Examination of usefulness of two kinds of synthetic skin surface adhesives for managing surgical wound in total hip arthroplasty |
| Date of disclosure of the study information | 2020/05/02 |
| Last modified on | 2023/08/08 21:31:59 |
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Basic information
Public title
Examination of usefulness of synthetic skin surface adhesive as surgical wound management in total hip arthroplasty.
Acronym
Usefulness of synthetic skin surface adhesives
Scientific Title
Examination of usefulness of two kinds of synthetic skin surface adhesives for managing surgical wound in total hip arthroplasty
Scientific Title:Acronym
Usefulness of synthetic skin surface adhesives
Region
| Japan |
Condition
Condition
Osteoarthritis of the hip
Idiopathic osteonecrosis of femoral head
Femoral neck fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the usefulness of two kinds of synthetic skin surface adhesives.
We will also investigate the utility of a synthetic skin surface adhesive in combination with Steri Strip, a medical tape formulation used to close wounds.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Wound condition: presence or absence of wound dehiscence, redness, edema, inflammation, dermatitis, discharge, bleeding, infection, foreign body reaction, allergic reaction, postoperative scar formation (10 days after surgery, about 1.5 months after surgery, about 3 months after surgery).
Key secondary outcomes
Material cost from the viewpoint of medical economy.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Group using DERMABOND
Wound survey 10 days after surgery, approximately 1.5 months after surgery, and approximately 3 months after surgery.
Interventions/Control_2
Group using LIQUIBAND
Wound survey 10 days after surgery, approximately 1.5 months after surgery, and approximately 3 months after surgery.
Interventions/Control_3
Group using LIQUIBAND with Steri strip
Wound survey 10 days after surgery, approximately 1.5 months after surgery, and approximately 3 months after surgery.
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
Patients undergoing primary total hip arthroplasty (THA) at Kitasato University Hospital for osteoarthritis, idiopathic necrosis of the femoral head, and femoral neck fracture.
Key exclusion criteria
Patients who underwent the anterolateral approach participated in this study and excluded other approaches. Patients who are considered unsuitable for participation in this study by their doctor will also be excluded.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Katsufumi |
| Middle name | |
| Last name | Uchiyama |
Organization
Kitasato Univ.
Division name
Department of Orthopaedic Surgery, School of Medicine
Zip code
2520374
Address
1-15-1 Kitasato, minami-ku,Sagamihara, Kanagawa, JAPAN
TEL
0427788111
katsufu@cf6.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Katsufumi |
| Middle name | |
| Last name | Uchiyama |
Organization
Kitasato Univ.
Division name
Department of Orthopaedic Surgery, School of Medicine
Zip code
2520374
Address
1-15-1 Kitasato, minami-ku,Sagamihara, Kanagawa, JAPAN
TEL
0427788111
Homepage URL
katsufu@cf6.so-net.ne.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, School of Medicine, Kitasato Univ.
Institute
Department
Personal name
Funding Source
Organization
Kitasato Univ.
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
Kitasato University Hospital Ethics Office
Address
8F 1-15-1 Kitasato, minami-ku,Sagamihara, Kanagawa, JAPAN
Tel
042-778-8273
rinrib@med.kitasato-u.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
北里大学病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 02 | 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
300
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 02 | Day |
Last modified on
| 2023 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045940
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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