UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054777 |
|---|---|
| Receipt number | R000062600 |
| Scientific Title | Investigation of Wound Healing of Secondary Healing Hydrogel Wound Dressing/Protective Material for Segmental Skin Grafting Wounds |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/06/26 13:58:24 |
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Basic information
Public title
Investigation of Wound Healing of Secondary Healing Hydrogel Wound Dressing/Protective Material for Segmental Skin Grafting Wounds
Acronym
Investigation of Secondary Healing Hydrogel Wound Dressing/Protective Material for Segmental Skin Grafting Wounds
Scientific Title
Investigation of Wound Healing of Secondary Healing Hydrogel Wound Dressing/Protective Material for Segmental Skin Grafting Wounds
Scientific Title:Acronym
Investigation of Secondary Healing Hydrogel Wound Dressing/Protective Material
Region
| Japan |
Condition
Condition
Intractable skin ulcers
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although wound dressings are the established standard of care for segmental skin grafting wounds, secondary damage is often a problem due to adhesion to the wound. Secondary damage can prolong the wound healing period and in some cases, lead to difficult-to-heal ulcers. We will analyze clinically and pathologically the effect of a newly developed secondary healing hydrogel wound dressing/protective material that does not adhere to the wound to promote wound healing for segmental skin grafting wounds.
Translated with www.DeepL.com/Translator (free version)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time from surgery (secondary healing hydrogel wound dressing/protective material applied) to complete healing
Key secondary outcomes
pain, surface environment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Secondary healing hydrogel wound dressing/protective material
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing segmental skin grafting for refractory ulcers
Key exclusion criteria
Persons who have significant difficulty in understanding the purpose of the research and in making decisions regarding the use of wound imaging data and medical information maintained by the individual.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Norihiko |
| Middle name | |
| Last name | Ohura |
Organization
Kyorin University
Division name
Plastic, Reconstructive and Aesthetic Surgery
Zip code
1818611
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
norihiko.ohura@gmail.com
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Nagasaka |
Organization
Kyorin University
Division name
Plastic, Reconstructive and Aesthetic Surgery
Zip code
1818611
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
Homepage URL
nagasakamd@gmail.com
Sponsor or person
Institute
Norihiko Ohura, Plastic, Reconstructive and Aesthetic Surgery, Kyorin university
Institute
Department
Personal name
Norihiko Ohura
Funding Source
Organization
Kyorin University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Plastic, Reconstructive and Aesthetic Surgery, Kyorin University
Address
6-20-2 Shinkawa, Mitaka, Tokyo
Tel
0422-47-5511
nagasakamd@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 26 | Day |
Last modified on
| 2024 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062600
