Unique ID issued by UMIN | UMIN000019420 |
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Receipt number | R000022450 |
Scientific Title | A single-center, prospective, randomized, open-label, clinical trial of ceramide 2-containing hydrocolloid dressings versus polyurethane film dressings for pressure ulcer prevention in high-risk surgical patients |
Date of disclosure of the study information | 2015/10/23 |
Last modified on | 2015/10/26 13:16:00 |
A single-center, prospective, randomized, open-label, clinical trial of ceramide 2-containing hydrocolloid dressings versus polyurethane film dressings for pressure ulcer prevention in high-risk surgical patients
A study on dressings for pressure ulcer prevention during surgery.
A single-center, prospective, randomized, open-label, clinical trial of ceramide 2-containing hydrocolloid dressings versus polyurethane film dressings for pressure ulcer prevention in high-risk surgical patients
A study on dressings for pressure ulcer prevention during surgery.
Japan |
Pressure ulcer
Dermatology | Plastic surgery | Nursing |
Others
NO
This study was to compare the effects of ceramide 2-containing hydrocolloid dressing with film dressings in reducing the incidence of pressure ulcer development during surgery in patients with a high risk of developing pressure ulcers.
Efficacy
Confirmatory
Pragmatic
Not applicable
The incidence rate of pressure ulcer development in high-risk surgical patients in both groups.The development of a pressure ulcer was visually observed by one WOC nurse within 24 hours postsurgery.
Incidence of skin damage, such as blanchable erythema, skin discoloration, contact dermatitis, and stripped skin, at the intervention sites.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Prevention
Device,equipment |
Intervention group
Control group
Not applicable |
Not applicable |
Male and Female
Surgical patients at a high risk of developing pressure ulcers.
Patient who did not written informed consent to participate.
Patients with existing pressure damage and/or with a history of pressure ulcer at the intervention sites.
128
1st name | |
Middle name | |
Last name | Yasuhiro Kawachi |
Tokyo Medical University Ibaraki Medical Canter
Dermatology
3-20-1, Chuo, Ami, Inashiki, Ibaraki, Japan
029-887-1161
kyasuhir@tokyo-med.ac.jp
1st name | |
Middle name | |
Last name | Yasuhiro Kawachi |
Tokyo Medical University Ibaraki Medical Canter
Dermatology
3-20-1, Chuo, Ami, Inashiki, Ibaraki, Japan
029-887-1161
kyasuhir@tokyo-med.ac.jp
Pressure Ulcer Committee of Tokyo Medical University Ibaraki Medical Canter
ALCARE Co. Ltd.
Profit organization
Japan
NO
東京医科大学茨城医療センター(茨城県)
2015 | Year | 10 | Month | 23 | Day |
Unpublished
Completed
2014 | Year | 01 | Month | 05 | Day |
2014 | Year | 02 | Month | 04 | Day |
2014 | Year | 06 | Month | 30 | Day |
2014 | Year | 07 | Month | 15 | Day |
2015 | Year | 05 | Month | 07 | Day |
2015 | Year | 10 | Month | 20 | Day |
2015 | Year | 10 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022450
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