UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033048 |
|---|---|
| Receipt number | R000037678 |
| Scientific Title | A prospective randomized comparative study between the novel form dressing and conventional silver form dressing for exuding wounds |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2019/12/24 19:02:35 |
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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
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/
morimotn@hirakata.kmu.ac.jp
Sponsor or person
Institute
Department of Plastic and Reconstructive Surgery,Kansai Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037678
