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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040293
Receipt No. 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 2020/05/02

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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
Email 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
Email katsufu@cf6.so-net.ne.jp

Sponsor
Institute Department of Orthopaedic Surgery, School of Medicine, Kitasato Univ.

Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 05 Month 02 Day
Date of IRB
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2024 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 02 Day
Last modified on
2020 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045940

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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