Pressure InjuryNCT05441293
Determinants of the Success of Flap Reconstruction: Outcome Analysis of 484 Surgeries for Pressure Injury
An observational study of Pressure Injury, run by Taipei Medical University WanFang Hospital.
Trial summary
Background: Pressure injury (PI) mainly occurs in bedridden older adults or those with physical limitations. PI treatment is typically long-term, requiring coordination between health-care workers and the patient's caregiver. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pressure Injury
- What is being tested?
- flap reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 484 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 May 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients who received debridement or flap reconstruction surgery for Pressure injury in Wan Fang Hospital from January 2016 to December 2021
Who may be able to join
- all patients who received debridement or flap reconstruction surgery for Pressure injury in Wan Fang Hospital from January 2016 to December 2021
Who cannot join
- the patients who did not received debridement or flap reconstruction surgery for Pressure injury
About this study
Official title: b Division of Plastic Surgery, Department of Surgery, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan
Background: Pressure injury (PI) mainly occurs in bedridden older adults or those with physical limitations. PI treatment is typically long-term, requiring coordination between health-care workers and the patient's caregiver. Here, we aimed to determine the appropriate timing to conduct flap reconstruction in patients with PIs and identify factors affecting surgical outcomes.
Materials and Methods: We retrospectively reviewed the data of all patients who received debridement or flap reconstruction surgery for PIs in our hospital from January 2016 to December 2021. The extracted data included patient demographics, surgical records, blood test results, vital signs, and flap outcomes. Next, these characteristics including the flap outcomes of our patients with PIs were analyzed, along with the risk factors for poor wound healing and complications.
- Conditions
- Pressure Injury
- Being tested
- flap reconstruction
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flap reconstructionProcedure or surgery
received flap reconstruction over sacrum, back, trochanter, ischium, elbow, and lower extremities
| Study group | Role | What they receive |
|---|---|---|
| debridements group | During study peroid, the patient who received debridement surgery for pressure injury Receives: Procedure: flap reconstruction | |
| flap reconstructions group | During study peroid, the patient who received flap reconstruction surgery for pressure injury Receives: Procedure: flap reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete wound healing
no presentation of wound drainage or wound dehiscence at the surgical site 14 days after drainage tube removal.
Measured: from January 2016 to December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 Jan 2016
- Primary completion1 Dec 2021
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441293
- Sponsor's protocol ID
- WanFangW2
- Status last verified
- Jun 2022
- First submitted
- 28 Jun 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the data are not available for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- b Division of Plastic Surgery, Department of Surgery, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan
- ClinicalTrials.gov ID
- NCT05441293
- Acronym / sponsor ID
- WanFangW2
- Conditions
- Pressure Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 1 Jul 2022 (actual)
- 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.
Background: Pressure injury (PI) mainly occurs in bedridden older adults or those with physical limitations. PI treatment is typically long-term, requiring coordination between health-care workers and the patient's caregiver. Here, we aimed to determine the appropriate timing to conduct flap reconstruction in patients with PIs and identify factors affecting surgical outcomes.
Materials and Methods: We retrospectively reviewed the data of all patients who received debridement or flap reconstruction surgery for PIs in our hospital from January 2016 to December 2021. The extracted data included patient demographics, surgical records, blood test results, vital signs, and flap outcomes. Next, these characteristics including the flap outcomes of our patients with PIs were analyzed, along with the risk factors for poor wound healing and complications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| debridements group | – | Procedure: flap reconstructionDuring study peroid, the patient who received debridement surgery for pressure injury |
| flap reconstructions group | – | Procedure: flap reconstructionDuring study peroid, the patient who received flap reconstruction surgery for pressure injury |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients who received debridement or flap reconstruction surgery for Pressure injury in Wan Fang Hospital from January 2016 to December 2021
Key inclusion criteria (1 listed)
- all patients who received debridement or flap reconstruction surgery for Pressure injury in Wan Fang Hospital from January 2016 to December 2021
Key exclusion criteria (1 listed)
- the patients who did not received debridement or flap reconstruction surgery for Pressure injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flap reconstructionreceived flap reconstruction over sacrum, back, trochanter, ischium, elbow, and lower extremities | Procedure or surgery | debridements group, flap reconstructions group |
Primary outcome
Complete wound healing
Time frame: from January 2016 to December 2021
no presentation of wound drainage or wound dehiscence at the surgical site 14 days after drainage tube removal.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Individual participant dataSharing planned: No. the data are not available for sharing.
Related trials for Pressure Injury
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Injury, run by Taipei Medical University WanFang Hospital.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete wound healing (time frame: from January 2016 to December 2021). 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 1 Jul 2022.