Postoperative Pressure Injury in Patients Undergoing Prone Spinal Surgery

NCT ID: NCT03965169

Last Updated: 2019-05-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 299 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2020-05-31

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.

Conditions

Pressure Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Prone spinal surgery

Intervention Type: PROCEDURE

spinal surgery in prone position under general anesthesia

Interventions

Prone spinal surgery

spinal surgery in prone position under general anesthesia

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Pre-existence of pressure injury

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyongmin Oh, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Central Contacts

Heepyoung Park, MD, Phd

Role: CONTACT

hppark@snu.ac.kr

82-2-2072-2466

Hyongmin Oh, MD

Role: CONTACT

hyungmin0118@naver.com

82-2-2072-2469

Facility Contacts

Heepyoung Park, MD, PhD

Role: primary

hppark@snu.ac.kr

82-2-2072-2466

Hyongmin Oh, MD

Role: backup

hyungmin0118@naver.com

82-2-2072-2469

References

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.

Reference Type: BACKGROUND

PMID: 28368987 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12100644 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29441175 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22241195 (View on PubMed)

Other Identifiers

Pressure injury

Identifier Type: -

Identifier Source: org_study_id