UMIN-CTR Clinical Trial

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