Postoperative Pressure UlcerNCT02279355
Peri-operative Risk Factors for Postoperative Pressure Ulcer in Surgical Patients
An observational study of Postoperative Pressure Ulcer, run by Yonsei University.
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. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Postoperative Pressure Ulcer
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients will be excluded from the study if they had been diagnosed with pressure ulcer before the surgery
- Pediatric patients
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Postoperative Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pressure UlcerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sung Won Na, MD, Principal investigator, Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279355
- Sponsor's protocol ID
- 4-2014-0323
- Status last verified
- Oct 2014
- First submitted
- 13 Oct 2014
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-operative Risk Factors for Postoperative Pressure Ulcer in Surgical Patients
- ClinicalTrials.gov ID
- NCT02279355
- Acronym / sponsor ID
- 4-2014-0323
- Conditions
- Postoperative Pressure Ulcer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients will be excluded from the study if they had been diagnosed with pressure ulcer before the surgery
- Pediatric patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung Won Na, MD principal investigator
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute Yonsei University College of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pressure Ulcer, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeongmin Kim, MD ((+82) 2-2227-3569, anesjeongmin@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
independent preoperative risk factors (time frame: up to1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2014.