UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019420
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

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Basic information

Public 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

Acronym

A study on dressings for pressure ulcer prevention during surgery.

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

Scientific Title:Acronym

A study on dressings for pressure ulcer prevention during surgery.

Region

Japan


Condition

Condition

Pressure ulcer

Classification by specialty

Dermatology Plastic surgery Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

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.

Key secondary outcomes

Incidence of skin damage, such as blanchable erythema, skin discoloration, contact dermatitis, and stripped skin, at the intervention sites.


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

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Intervention group

Interventions/Control_2

Control group

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Surgical patients at a high risk of developing pressure ulcers.

Key exclusion criteria

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.

Target sample size

128


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuhiro Kawachi

Organization

Tokyo Medical University Ibaraki Medical Canter

Division name

Dermatology

Zip code


Address

3-20-1, Chuo, Ami, Inashiki, Ibaraki, Japan

TEL

029-887-1161

Email

kyasuhir@tokyo-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasuhiro Kawachi

Organization

Tokyo Medical University Ibaraki Medical Canter

Division name

Dermatology

Zip code


Address

3-20-1, Chuo, Ami, Inashiki, Ibaraki, Japan

TEL

029-887-1161

Homepage URL


Email

kyasuhir@tokyo-med.ac.jp


Sponsor or person

Institute

Pressure Ulcer Committee of Tokyo Medical University Ibaraki Medical Canter

Institute

Department

Personal name



Funding Source

Organization

ALCARE Co. Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


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

東京医科大学茨城医療センター(茨城県)


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 23 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

Completed

Date of protocol fixation

2014 Year 01 Month 05 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 04 Day

Last follow-up date

2014 Year 06 Month 30 Day

Date of closure to data entry

2014 Year 07 Month 15 Day

Date trial data considered complete


Date analysis concluded

2015 Year 05 Month 07 Day


Other

Other related information



Management information

Registered date

2015 Year 10 Month 20 Day

Last modified on

2015 Year 10 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022450


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name