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Peri-operative Risk Factors for Postoperative Pressure Ulcer in Surgical Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02279355
Recruitment Status : Unknown
Verified October 2014 by Yonsei University.
Recruitment status was:  Not yet recruiting
First Posted : October 31, 2014
Last Update Posted : October 31, 2014
Information provided by (Responsible Party):
Yonsei University

Brief 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.

Condition or disease
Postoperative Pressure Ulcer

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Study Type : Observational
Estimated Enrollment : 126 participants
Observational Model: Case Control
Time Perspective: Retrospective
Study Start Date : October 2014
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

pressure ulcer group
Patient who developing pressure ulcer categorized as stage more than II after surgery
Control group
Patients has identical values on the matching factors such as age, sex and surgical procedures of control group

Primary Outcome Measures :
  1. independent preoperative risk factors [ Time Frame: up to1 month after surgery ]
    Postoperative new-onset pressure ulcers were identified from nursing documentation in the patient's electrical medical record within 1 month after surgery

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Total about 130 adult surgical patients underwent surgical procedures and admitted in intensive care unit (ICU) using electronic documentation applications from Jan 2012 through Dec 2013.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02279355

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Contact: Jeongmin Kim, MD (+82) 2-2227-3569

Sponsors and Collaborators
Yonsei University
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Principal Investigator: Sung Won Na, MD Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute Yonsei University College of Medicine

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Responsible Party: Yonsei University Identifier: NCT02279355    
Other Study ID Numbers: 4-2014-0323
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: October 31, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Pressure Ulcer
Skin Ulcer
Skin Diseases