UMIN-CTR Clinical Trial

Basic information
Public title	A prospective randomized comparative study between the novel form dressing and conventional silver form dressing for exuding wounds
Acronym	A comparative study between the novel form dressing and conventional silver form dressing
Scientific Title	A prospective randomized comparative study between the novel form dressing and conventional silver form dressing for exuding wounds
Scientific Title:Acronym	A comparative study between the novel form dressing and conventional silver form dressing
Region	Japan

Condition
Condition	traumatic wounds,postoperative wound dehiscence or chronic skin ulcers
Classification by specialty	Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of the novel forma dressings compared to the silver foam dressings for traumatic wounds,postoperative wound dehiscence or chronic skin ulcers
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	The decrease of the bacteria count on Day 4
Key secondary outcomes	1.The decrease rate of the bacteria count 2.The decrease rate of the wound area 3.The Improvement of the score of wound exudate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Apply the novel dressings after its irrigation using saline, distilled water or tap water.
Interventions/Control_2	Apply the silver dressings after its irrigation using saline, distilled water or tap water.
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	1.20 years of age or over 2.traumatic wounds, postoperative wounds 3.Maximum area of ulcer is within 11cmx11cm 4.written informed consent
Key exclusion criteria	1.Patient's ulcer is with extensive exposure of tendon or bone 2.wounds with a severe infection
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoki MORIMOTO
Organization	Kansai Medical University
Division name	Department of Plastic and Reconstructive Surgery
Zip code
Address	2-5-1 Shin-machi, Hirakata City,Osaka
TEL	072-804-0101
Email	morimotn@hirakata.kmu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Naoki MORIMOTO
Organization	Kansai Medical University
Division name	Department of Plastic and Reconstructive Surgery
Zip code
Address	2-5-1 Shin-machi, Hirakata City, Osaka
TEL	072-804-0101
Homepage URL	http://kmu-prs.adiva.jp/
Email	morimotn@hirakata.kmu.ac.jp

Sponsor
Institute	Department of Plastic and Reconstructive Surgery,Kansai Medical University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	関西医科大学附属病院

Other administrative information
Date of disclosure of the study information	2018 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	Terminated
Date of protocol fixation	2018 Year 06 Month 01 Day
Date of IRB	2018 Year 06 Month 01 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date	2019 Year 08 Month 31 Day
Date of closure to data entry	2019 Year 12 Month 31 Day
Date trial data considered complete	2019 Year 12 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 06 Month 19 Day
Last modified on	2019 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037678