UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037402 |
|---|---|
| Receipt number | R000042613 |
| Scientific Title | The risk factors of intraoperative acquired pressure injury in spinal surgery by using prophylactic film dressing. |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2019/07/17 19:32:58 |
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Basic information
Public title
The risk factors of intraoperative acquired pressure injury in spinal surgery by using prophylactic film dressing.
Acronym
The risk factors of intraoperative acquired pressure injury in spinal surgery by using prophylactic film dressing.
Scientific Title
The risk factors of intraoperative acquired pressure injury in spinal surgery by using prophylactic film dressing.
Scientific Title:Acronym
The risk factors of intraoperative acquired pressure injury in spinal surgery by using prophylactic film dressing.
Region
| Japan |
Condition
Condition
spinal disease
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the coincidence and to extract the risk factors of pressure injuries when using polyurethane film dressing in IAPU prevention before the BOSS trial period.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To classify patients into two groups: "with IAPIs group" and "without IAPIs group". The relative risk for IAPIs development was analyzed based on characteristics and intraoperative risk factors.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients who undergoing scheduled posterior spinal surgery in a prone position using the Relton-Hall frame.
Key exclusion criteria
emergency surgery, Micro Endoscopic Discectomy (MED), those with skin disorders, spondylosis deformation, and under 20 years of age.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Norihiko |
| Middle name | |
| Last name | Ohura |
Organization
Kyorin University School of Medicine
Division name
Department of Plastic, Reconstructive and Aesthetic Surgery
Zip code
181-8611
Address
6-20-2 Shenkawa, Mitaka, Tokyo
TEL
0422-46-6138
norihiko.ohura@gmail.com
Public contact
Name of contact person
| 1st name | Norihiko |
| Middle name | |
| Last name | Ohura |
Organization
Kyorin University School of Medicine
Division name
Department of Plastic, Reconstructive and Aesthetic Surgery
Zip code
181-8611
Address
6-20-2 Shenkawa, Mitaka, Tokyo
TEL
0422-46-6138
Homepage URL
norihiko.ohura@gmail.com
Sponsor or person
Institute
Kyorin University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyorin University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Medical University Hospital,Tokyo Metropolitan Police Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyorin University School of Medicine
Address
6-20-2 Shenkawa, Mitaka, Tokyo
Tel
0422-47-5511
norihiko.ohura@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
東京警察病院
Other administrative information
Date of disclosure of the study information
| 2020 | 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
107
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
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Medical records: age, gender, BMI, medical history, Braden scale score , American Society of Anesthesiologists (ASA)
physical status classification, presence of bony prominence, oedema or paralysis and the blood test data, including the
haemoglobin and albumin.
Intraoperative factors
were obtained from the medical records: surgical procedure, diastolic blood pressure <50 mmHg (yes/no), length of surgery, bleeding amount and core temperature (bladder or rectum).
The parameters of the core temperature were the baseline, end and the change between the baseline and the end of surgery.
Management information
Registered date
| 2019 | Year | 07 | Month | 17 | Day |
Last modified on
| 2019 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042613
