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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03965169
Other study ID # Pressure injury
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2019
Est. completion date May 31, 2020

Study information

Verified date April 2019
Source Seoul National University Hospital
Contact Heepyoung Park, MD, Phd
Phone 82-2-2072-2466
Email hppark@snu.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 299
Est. completion date May 31, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 79 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Pre-existence of pressure injury

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Prone spinal surgery
spinal surgery in prone position under general anesthesia

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View Citation

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. — View Citation

Scarlatti KC, Michel JL, Gamba MA, de Gutiérrez MG. [Pressure ulcers in surgery patients: incidence and associated factors]. Rev Esc Enferm USP. 2011 Dec;45(6):1372-9. Portuguese. — View Citation

Schoonhoven L, Defloor T, Grypdonck MH. Incidence of pressure ulcers due to surgery. J Clin Nurs. 2002 Jul;11(4):479-87. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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