Postoperative Pressure Injury in Patients Undergoing Prone Spinal Surgery

Incidence and Risk Factors of Postoperative Pressure Injury in Patients Undergoing Prone Spinal Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Pressure Injury
• Intervention / Treatment: Procedure: Prone spinal surgery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 299
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-799
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pre-existence of pressure injury

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From end of surgery to postoperative day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From end of surgery to postoperative day 2
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".	From end of surgery to postoperative day 2

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Hyongmin Oh, MD, Seoul National University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2019
• Primary Completion (ANTICIPATED): March 31, 2020
• Study Completion (ANTICIPATED): May 31, 2020

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (ACTUAL): May 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 24, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Crush Injuries
• Other Study ID Numbers: Pressure injury

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No