UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054397 |
|---|---|
| Receipt number | R000062137 |
| Scientific Title | Evaluation of the usefulness of a lower limb trestle utilizing a new type of wool mat for skin graft patients. |
| Date of disclosure of the study information | 2024/08/31 |
| Last modified on | 2024/11/13 11:39:02 |
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Basic information
Public title
Evaluation of the usefulness of a lower limb trestle utilizing a new type of wool mat for skin graft patients.
Acronym
Evaluation of the usefulness of a lower limb trestle utilizing a new type of wool mat for skin graft patients.
Scientific Title
Evaluation of the usefulness of a lower limb trestle utilizing a new type of wool mat for skin graft patients.
Scientific Title:Acronym
Evaluation of the usefulness of a lower limb trestle utilizing a new type of wool mat for skin graft patients.
Region
| Japan |
Condition
Condition
Patients with skin implants
Classification by specialty
| Plastic surgery | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will compare and verify the comfort of a new wool mat for lower limb trestles for patients with skin implants, and investigate its usefulness in actual clinical practice.
Basic objectives2
Others
Basic objectives -Others
Comfort verification of new wool mats
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Questionnaires and Interviews with Patients
Questionnaire for nurses
Key secondary outcomes
None
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
If Monday is the surgery day, Group A will use the normal lower limb trestle from Tuesday after extubation to the third postoperative day, and from Friday afternoon of the fourth day, a lower limb trestle with a new type of wool mat wrapped around it will be used, and the survey and interview will be completed on Monday afternoon.
Interventions/Control_2
If Monday is the day of surgery, Group B will use a lower limb trestle with a new type of wool mat wrapped around it from Tuesday after extubation to the third postoperative day, and from Friday afternoon of the fourth day, a regular lower limb trestle will be used, which will be completed on Monday afternoon and questionnaires and interviews will be conducted.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients:
Patients who have undergone skin grafting and whose attending physicians determine that they are eligible for the study will be included. The patients will be assigned a number when they agree to cooperate in the study. This will be a randomized controlled trial, with odd numbers assigned to group A and even numbers assigned to group B. The study will be conducted on three days during the six-day postoperative period, one day using the new wool mat wrapped lower limb trestle and three days using the conventional lower limb trestle, so that eligible patients will experience both types of lower limb trestles.
Nurses:
Nurses who were engaged in care (patient observation and nursing activities including daily ward duties such as blood pressure monitoring and wiping) during the study period.
Key exclusion criteria
Patients:
Exclusion criteria will be patients deemed inappropriate by the attending physician and those who have developed skin problems, are in severe mental or physical distress, or whose consent could not be obtained.
Nurses:
Those for whom consent could not be obtained.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | YOSHIE |
| Middle name | |
| Last name | IMAI |
Organization
Tokushima University
Division name
Cancer Nursing
Zip code
770-8509
Address
3-18-15 Kuramoto-cho, Tokushima,
TEL
088-633-9038
imai@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | yoshie |
| Middle name | |
| Last name | IMAI |
Organization
Tokushima University
Division name
Cancer nursing
Zip code
770-8509
Address
3-18-15 Kuramoto-cho, Tokushima,
TEL
088-633-9038
Homepage URL
imai@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
YOSHIE IMAI
Funding Source
Organization
Tokushima 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
The Ethics Committee of Tokushima University Hospital
Address
2-50-1, Kuramoto-cho, Tokushima
Tel
088-631-3111
first-ec@tokushima-u.ac.jp
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
徳島大学病院(徳島県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2026 | 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 | 05 | Month | 14 | Day |
Last modified on
| 2024 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062137
