UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021696 |
|---|---|
| Receipt number | R000025029 |
| Scientific Title | The effectiveness of soft silicone multi-layered foam dressings for preventing intraoperatively acquired pressure ulcers (IAPUS) in spinal surgery patients |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2016/03/30 21:42:11 |
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Basic information
Public title
The effectiveness of soft silicone multi-layered foam dressings for preventing intraoperatively acquired pressure ulcers (IAPUS) in spinal surgery patients
Acronym
The effectiveness of soft silicone multi-layered foam dressings for preventing intraoperatively acquired pressure ulcers (IAPUS) in spinal surgery patients
Scientific Title
The effectiveness of soft silicone multi-layered foam dressings for preventing intraoperatively acquired pressure ulcers (IAPUS) in spinal surgery patients
Scientific Title:Acronym
The effectiveness of soft silicone multi-layered foam dressings for preventing intraoperatively acquired pressure ulcers (IAPUS) in spinal surgery patients
Region
| Japan |
Condition
Condition
A patient who underwent elective spine surgery
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate the prevention effect of soft silicone multi-layered foam dressing for intraoperatively acquired pressure ulcers (IAPUs) in spinal surgery patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dressings
Key secondary outcomes
Age, Sex, BMI, Braden scale score, Diabetes, Congestive heart failure, Hypertension, Bony prominence, Edema, Paralysis, Systolic blood pressure less than 50mmHg, ASA-Physical status classification, Hemoglobin level, Albumin level,Length of surgery, Amount of bleeding
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Comparison between the right side and left side of the same patient
Skin polyurethane film (control) was applied on the right side of the chest and iliac crest.
Interventions/Control_2
Soft silicone multi-layered foam dressings was applied on the left side of the chest and iliac crest.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A patient who underwent elective spine surgery in the prone position using the Relton-Hall frame
Key exclusion criteria
emergency surgery, repeated surgery, skin disorders or scars in the area to be observed,
severe vertebral deformity
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiko Ohura |
Organization
Kyorin University School of Medicine, Tokyo, Japan
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo, Japan
TEL
0422-47-5511
nohura-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mine Yoshimura |
Organization
Tokyo Metropolitan Police Hospital, Tokyo, Japan
Division name
Department of Nursing
Zip code
Address
4-22-1 Nakano, Nakano-ku, Tokyo, Japan
TEL
03-5343-5611
Homepage URL
miney-tky@umin.ac.jp
Sponsor or person
Institute
Kyorin University School of Medicine, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
Kyorin University School of Medicine, Tokyo, Japan
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2016 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 30 | Day |
Last modified on
| 2016 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025029
