NCT03965169

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
299

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

May 28, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

April 25, 2019

Last Update Submit

May 24, 2019

Conditions

Pressure Injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Site of pressure injury

    From end of surgery to postoperative day 2

  • Grade of pressure injury

    From end of surgery to postoperative day 2

Study Arms (1)

Patients undergoing prone spinal surgery

EXPERIMENTAL

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

Interventions

Prone spinal surgeryPROCEDURE

spinal surgery in prone position under general anesthesia

Patients undergoing prone spinal surgery

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pre-existence of pressure injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-799, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 28368987BACKGROUND

  • 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.

    PMID: 12100644BACKGROUND

  • 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.

    PMID: 29441175BACKGROUND

  • 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.

    PMID: 22241195BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hyongmin Oh, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heepyoung Park, MD, Phd

CONTACT

82-2-2072-2466hppark@snu.ac.kr

Hyongmin Oh, MD

CONTACT

82-2-2072-2469hyungmin0118@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2019

First Posted

May 28, 2019

Study Start

June 1, 2019

Primary Completion

March 31, 2020

Study Completion

May 31, 2020

Last Updated

May 28, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)