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Postoperative Pressure Injury in Patients Undergoing Prone Spinal Surgery

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03965169
Enrollment
299
Registered
2019-05-28
Start date
2019-06-01
Completion date
2020-05-31
Last updated
2019-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Injury

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.

Interventions

PROCEDUREProne spinal surgery

spinal surgery in prone position under general anesthesia

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Pre-existence of pressure injury

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of pressure injuryFrom end of surgery to postoperative day 2The 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

MeasureTime frameDescription
Site of pressure injuryFrom end of surgery to postoperative day 2The 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 injuryFrom end of surgery to postoperative day 2he 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.

Countries

South Korea

Contacts

Primary ContactHeepyoung Park, MD, Phd
hppark@snu.ac.kr82-2-2072-2466
Backup ContactHyongmin Oh, MD
hyungmin0118@naver.com82-2-2072-2469

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026