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

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.

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.

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