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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02279355
Other study ID # 4-2014-0323
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 13, 2014
Last updated October 27, 2014
Start date October 2014
Est. completion date December 2014

Study information

Verified date October 2014
Source Yonsei University
Contact Jeongmin Kim, MD
Phone (+82) 2-2227-3569
Email anesjeongmin@yuhs.ac
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

The aim of this retrospective study is to overall evaluate and validate preoperative and intra-operative risk factors for postoperative pressure ulcers in critically ill postoperative patients.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 126
Est. completion date December 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 90 Years
Eligibility Inclusion Criteria:

- Patients in ICU with a greater than 48 hours

- Underwent a surgical procedures,

- Absence of pressure ulcer present at admission to the ICU and developed a stage II or higher pressure ulcer, deep tissue injury, or unstageable ulcer, as defined by the pressure ulcer staging guidelines of the National Pressure Ulcer Advisory Panel.

Exclusion Criteria:

- Patients will be excluded from the study if they had been diagnosed with pressure ulcer before the surgery

- Pediatric patients

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Outcome

Type Measure Description Time frame Safety issue
Primary independent preoperative risk factors Postoperative new-onset pressure ulcers were identified from nursing documentation in the patient's electrical medical record within 1 month after surgery up to1 month after surgery No