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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037402
Receipt No. 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

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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
Email 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
Email norihiko.ohura@gmail.com

Sponsor
Institute Kyorin University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042613

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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