UMIN-CTR Clinical Trial

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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