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Postoperative Pressure Injury in Patients Undergoing Prone Spinal Surgery

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ClinicalTrials.gov Identifier: NCT03965169
Recruitment Status : Not yet recruiting
First Posted : May 28, 2019
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Pressure Injury Procedure: Prone spinal surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 299 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Incidence and Risk Factors of Postoperative Pressure Injury in Patients Undergoing Prone Spinal Surgery
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : May 31, 2020

Arm Intervention/treatment
Experimental: Patients undergoing prone spinal surgery
Patients undergoing elective spinal surgery in prone position under general anesthesia, which is performed by neurosurgeons in Seoul National University Hospital
Procedure: Prone spinal surgery
spinal surgery in prone position under general anesthesia




Primary Outcome Measures :
  1. Prevalence of pressure injury [ Time Frame: From end of surgery to postoperative day 2 ]
    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 :
  1. Site of pressure injury [ Time Frame: From end of surgery to postoperative day 2 ]
    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.

  2. Grade of pressure injury [ Time Frame: From end of surgery to postoperative day 2 ]
    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".



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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults patients undergoing elective spine surgery in prone position under general anesthesia

Exclusion Criteria:

  • Pre-existence of pressure injury

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965169


Contacts
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Contact: Heepyoung Park, MD, Phd 82-2-2072-2466 hppark@snu.ac.kr
Contact: Hyongmin Oh, MD 82-2-2072-2469 hyungmin0118@naver.com

Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-799
Contact: Heepyoung Park, MD, PhD    82-2-2072-2466    hppark@snu.ac.kr   
Contact: Hyongmin Oh, MD    82-2-2072-2469    hyungmin0118@naver.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Hyongmin Oh, MD Seoul National University Hospital
Publications:
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03965169    
Other Study ID Numbers: Pressure injury
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries
Crush Injuries