Postoperative Pressure Injury in Patients Undergoing Prone Spinal Surgery
Primary Purpose
Pressure Injury
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Prone spinal surgery
Sponsored by
About this trial
This is an interventional screening trial for Pressure Injury
Eligibility Criteria
Inclusion Criteria:
- Adults patients undergoing elective spine surgery in prone position under general anesthesia
Exclusion Criteria:
- Pre-existence of pressure injury
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients undergoing prone spinal surgery
Arm Description
Patients undergoing elective spinal surgery in prone position under general anesthesia, which is performed by neurosurgeons in Seoul National University Hospital
Outcomes
Primary Outcome Measures
Prevalence of pressure injury
The pressure injury after prone spine surgery will be identified and evaluated using "Pressure injury staging illustration - National Pressure Ulcer Advisory Panel" at end of surgery, postoperative day 1 and 2. The prevalence of pressure injury will be calculated by dividing the number of patients with pressure injury by the total number of patients.
Secondary Outcome Measures
Site of pressure injury
The pressure injury after prone spine surgery will be identified and evaluated using "Pressure injury staging illustration - National Pressure Ulcer Advisory Panel" at end of surgery, postoperative day 1 and 2. The site of pressure injury will be categorized as head, chest, abdomen, arm, leg and others.
Grade of pressure injury
he pressure injury after prone spine surgery will be identified and evaluated using "Pressure injury staging illustration - National Pressure Ulcer Advisory Panel" at end of surgery, postoperative day 1 and 2. The grade of pressure injury will be categorized as 1, 2, 3, and 4 according to the definition in "Pressure injury staging illustration - National Pressure Ulcer Advisory Panel".
Full Information
NCT ID
NCT03965169
First Posted
April 25, 2019
Last Updated
May 24, 2019
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03965169
Brief Title
Postoperative Pressure Injury in Patients Undergoing Prone Spinal Surgery
Official Title
Incidence and Risk Factors of Postoperative Pressure Injury in Patients Undergoing Prone Spinal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Anticipated)
Primary Completion Date
March 31, 2020 (Anticipated)
Study Completion Date
May 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Patients undergoing surgery under general anesthesia are susceptible to pressure-induced soft tissue damage because there is no change in posture over an extended period of time. In particular, when the patient is in a prone position, unlike the supine position, the bony protruding portion of the front side must support the weight, which is more vulnerable to pressure injury. Previous studies have shown that the incidence of pressure injury during surgery varied from 5% to 66% and was more likely to occur in patients with long operating times, prone position, obesity, and poor skin condition. These pressure injuries increase postoperative complications, length of stay, and medical costs. Therefore, the investigators analyze the incidence of pressure injury in prone position and re-examine the risk factors of pressure injury.
Detailed Description
All of the anesthetic and surgical procedures performed on the subject during the period from the time the subject enters the operating room to the time the subject go to the recovery room are the same as those for the existing spine surgery. Immediately after entering the operating room, immediately before going to the recovery room, and at postoperative day 1 and 2, the patient's systemic skin condition is assessed to determine whether pressure damage has occurred. The primary endpoint is the incidence of pressure injury in the subject compared with the incidence of pressure injury in previous studies. To identify the risk factors for the occurrence of pressure injury, the investigators will statistically analyze the data collected with the assumption that this is related.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Injury
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
299 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients undergoing prone spinal surgery
Arm Type
Experimental
Arm Description
Patients undergoing elective spinal surgery in prone position under general anesthesia, which is performed by neurosurgeons in Seoul National University Hospital
Intervention Type
Procedure
Intervention Name(s)
Prone spinal surgery
Intervention Description
spinal surgery in prone position under general anesthesia
Primary Outcome Measure Information:
Title
Prevalence of pressure injury
Description
The pressure injury after prone spine surgery will be identified and evaluated using "Pressure injury staging illustration - National Pressure Ulcer Advisory Panel" at end of surgery, postoperative day 1 and 2. The prevalence of pressure injury will be calculated by dividing the number of patients with pressure injury by the total number of patients.
Time Frame
From end of surgery to postoperative day 2
Secondary Outcome Measure Information:
Title
Site of pressure injury
Description
The pressure injury after prone spine surgery will be identified and evaluated using "Pressure injury staging illustration - National Pressure Ulcer Advisory Panel" at end of surgery, postoperative day 1 and 2. The site of pressure injury will be categorized as head, chest, abdomen, arm, leg and others.
Time Frame
From end of surgery to postoperative day 2
Title
Grade of pressure injury
Description
he pressure injury after prone spine surgery will be identified and evaluated using "Pressure injury staging illustration - National Pressure Ulcer Advisory Panel" at end of surgery, postoperative day 1 and 2. The grade of pressure injury will be categorized as 1, 2, 3, and 4 according to the definition in "Pressure injury staging illustration - National Pressure Ulcer Advisory Panel".
Time Frame
From end of surgery to postoperative day 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults patients undergoing elective spine surgery in prone position under general anesthesia
Exclusion Criteria:
Pre-existence of pressure injury
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heepyoung Park, MD, Phd
Phone
82-2-2072-2466
Email
hppark@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Hyongmin Oh, MD
Phone
82-2-2072-2469
Email
hyungmin0118@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyongmin Oh, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-799
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heepyoung Park, MD, PhD
Phone
82-2-2072-2466
Email
hppark@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Hyongmin Oh, MD
Phone
82-2-2072-2469
Email
hyungmin0118@naver.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28368987
Citation
Lin S, Hey HWD, Lau ETC, Tan KA, Thambiah JS, Lau LL, Kumar N, Liu KG, Wong HK. Prevalence and Predictors of Pressure Injuries From Spine Surgery in the Prone Position: Do Body Morphological Changes During Deformity Correction Increase the Risks? Spine (Phila Pa 1976). 2017 Nov 15;42(22):1730-1736. doi: 10.1097/BRS.0000000000002177.
Results Reference
background
PubMed Identifier
12100644
Citation
Schoonhoven L, Defloor T, Grypdonck MH. Incidence of pressure ulcers due to surgery. J Clin Nurs. 2002 Jul;11(4):479-87. doi: 10.1046/j.1365-2702.2002.00621.x.
Results Reference
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PubMed Identifier
29441175
Citation
Kim JM, Lee H, Ha T, Na S. Perioperative factors associated with pressure ulcer development after major surgery. Korean J Anesthesiol. 2018 Feb;71(1):48-56. doi: 10.4097/kjae.2018.71.1.48. Epub 2017 Jul 4.
Results Reference
background
PubMed Identifier
22241195
Citation
Scarlatti KC, Michel JL, Gamba MA, de Gutierrez MG. [Pressure ulcers in surgery patients: incidence and associated factors]. Rev Esc Enferm USP. 2011 Dec;45(6):1372-9. doi: 10.1590/s0080-62342011000600014. Portuguese.
Results Reference
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Postoperative Pressure Injury in Patients Undergoing Prone Spinal Surgery
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