- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02279355
Peri-operative Risk Factors for Postoperative Pressure Ulcer in Surgical Patients
October 27, 2014 updated by: Yonsei University
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
126
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
28 years to 88 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to1 month after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sung Won Na, MD, Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute Yonsei University College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Anticipated)
October 1, 2014
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
October 13, 2014
First Submitted That Met QC Criteria
October 27, 2014
First Posted (Estimate)
October 31, 2014
Study Record Updates
Last Update Posted (Estimate)
October 31, 2014
Last Update Submitted That Met QC Criteria
October 27, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2014-0323
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Pressure Ulcer
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The Cleveland ClinicRecruitingStage 1 Pressure Ulcer | Stage 2 Pressure UlcerUnited States, Austria
-
University GhentCare of Sweden ABCompletedPressure Ulcer | Pressure Injury | Pressure Ulcer, Buttock | Pressure SoreBelgium
-
Integra LifeSciences CorporationSt Vincent's HospitalCompletedPressure Ulcer | Pressure Ulcers Stage III | Pressure Ulcer, Stage IVUnited States
-
Our Lady of Maryknoll HospitalWong Tai Sin HospitalUnknownPressure Ulcers Stage III | Pressure Ulcer, Stage IVHong Kong
-
ULURU Inc.United States Department of DefenseRecruitingPressure Ulcers Stage II | Pressure Ulcers Stage III | Pressure Ulcer, Stage IVUnited States
-
Bayside HealthCompletedLength of ICU Stay | Pressure Ulcer, Area | Pressure Ulcer, Grade | Albumin Level | Risk ScoreAustralia
-
University of PittsburghUnited States Department of Defense; Georgia Institute of TechnologyCompletedPressure Ulcer | Pressure Injury | Pressure Ulcer, ButtockUnited States
-
Istituto Ortopedico RizzoliCompleted
-
Istanbul Medipol University HospitalCompletedPressure Ulcers Stage III | Pressure Ulcer, Stage IV
-
University of California, IrvineBeckman Laser Institute University of California IrvineWithdrawn