Pressure InjuryNCT05409170
The Change of Clinical Features and Surgical Outcomes in Patients With Pressure Injury During the COVID-19 Pandemic: A Retrospective Study
An observational study of Pressure Injury and COVID-19, run by Taipei Medical University WanFang Hospital.
Trial summary
The COVID-19 pandemic has considerably and negatively affected numerous lives and economies worldwide; specifically, it has led to delays in seeking medical treatment among many people [1-3]. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pressure Injury, COVID-19
- What is being tested?
- COVID
- Type of treatment
- Surgery or procedure
- How many people
- 213 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: the January 2016-December 2019 and January 2020-December 2021 intervals were defined as pre-COVID and COVID periods, respectively.
Who may be able to join
- all patients who received debridement or flap-reconstruction surgery for Pressure injury at Wan Fang Hospital from January 2016 to December 2021.
Who cannot join
- Patients who underwent debridement or flap-reconstruction surgery across the pre-COVID and COVID periods were excluded from the study.
About this study
Official title: Division of Plastic Surgery, Department of Surgery, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan
The COVID-19 pandemic has considerably and negatively affected numerous lives and economies worldwide; specifically, it has led to delays in seeking medical treatment among many people [1-3]. Delaying or avoiding seeking medical advice can result in worsened symptoms, delayed evaluation, and treatment complications [4-7]. Moreover, the pandemic has significantly impacted health-care systems, leading to numerous issues including shortages of medical staff, beds, equipment, medicines, and isolation facilities. The concern of cross-contamination-where COVID-19 may spread within wards unknowingly-has also increased the emotional burden among health-care workers [8-10].
Pressure injury (PI) is a common health issue particularly among older people who have physical limitations or are bedridden. PI management often requires a long-term individualized plan. Failure to implement this strategy may influence the quality of life and may cause wound-related psychosocial issues (e.g., low self-esteem), increase health-care expenditures, and shorten survival among the patients [11]. Moreover, long-term PIs are prone to infection and bleeding, which may lead to sepsis or anemia [12-14].
The current study explored whether COVID-19 pandemic-related changes affected the characteristics and treatment outcomes of patients with PIs.
- Conditions
- Pressure Injury, COVID-19
- Being tested
- COVID
- Medical subject headings
- Pressure Ulcer, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVIDProcedure or surgery
Each surgical procedure was considered an independent event. Moreover, the January 2016-December 2019 and January 2020-December 2021 intervals were defined as pre-COVID and COVID periods, respectively.
| Study group | Role | What they receive |
|---|---|---|
| pre-covid group | Each surgical procedure was considered an independent event. , the January 2016-December 2019 and January 2020-December 2021 intervals were defined as pre-COVID and COVID periods, respectively. | |
| covid group | Each surgical procedure was considered an independent event. , the January 2016-December 2019 and January 2020-December 2021 intervals were defined as pre-COVID and COVID periods, respectively. Receives: Procedure: COVID |
What is being measured
The primary outcome is the main question the study is designed to answer.
flap surgery outcomes
complete wound healing, major and minor complications, and recurrence.
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 posted8 Jun 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Kuan Chiu, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409170
- Sponsor's protocol ID
- WanFangW
- Status last verified
- Jun 2022
- First submitted
- 7 Jun 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The medical recoreds were saved in Wan Fang Hospital
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Division of Plastic Surgery, Department of Surgery, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan
- ClinicalTrials.gov ID
- NCT05409170
- Acronym / sponsor ID
- WanFangW
- Conditions
- Pressure Injury, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 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
- 8 Jun 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.
The COVID-19 pandemic has considerably and negatively affected numerous lives and economies worldwide; specifically, it has led to delays in seeking medical treatment among many people [1-3]. Delaying or avoiding seeking medical advice can result in worsened symptoms, delayed evaluation, and treatment complications [4-7]. Moreover, the pandemic has significantly impacted health-care systems, leading to numerous issues including shortages of medical staff, beds, equipment, medicines, and isolation facilities. The concern of cross-contamination-where COVID-19 may spread within wards unknowingly-has also increased the emotional burden among health-care workers [8-10].
Pressure injury (PI) is a common health issue particularly among older people who have physical limitations or are bedridden. PI management often requires a long-term individualized plan. Failure to implement this strategy may influence the quality of life and may cause wound-related psychosocial issues (e.g., low self-esteem), increase health-care expenditures, and shorten survival among the patients [11]. Moreover, long-term PIs are prone to infection and bleeding, which may lead to sepsis or anemia [12-14].
The current study explored whether COVID-19 pandemic-related changes affected the characteristics and treatment outcomes of patients with PIs.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-covid group | – | –Each surgical procedure was considered an independent event. , the January 2016-December 2019 and January 2020-December 2021 intervals were defined as pre-COVID and COVID periods, respectively. |
| covid group | – | Procedure: COVIDEach surgical procedure was considered an independent event. , the January 2016-December 2019 and January 2020-December 2021 intervals were defined as pre-COVID and COVID periods, respectively. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the January 2016-December 2019 and January 2020-December 2021 intervals were defined as pre-COVID and COVID periods, respectively.
Key inclusion criteria (1 listed)
- all patients who received debridement or flap-reconstruction surgery for Pressure injury at Wan Fang Hospital from January 2016 to December 2021.
Key exclusion criteria (1 listed)
- Patients who underwent debridement or flap-reconstruction surgery across the pre-COVID and COVID periods were excluded from the study.
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 |
|---|---|---|
| COVIDEach surgical procedure was considered an independent event. Moreover, the January 2016-December 2019 and January 2020-December 2021 intervals were defined as pre-COVID and COVID periods, respectively. | Procedure or surgery | covid group |
Primary outcome
flap surgery outcomes
Time frame: from January 2016 to December 2021
complete wound healing, major and minor complications, and recurrence.
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 8 Jun 2022.
- Individual participant dataSharing planned: No. The medical recoreds were saved in Wan Fang Hospital
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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.
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 and COVID-19, 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 8 Jun 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?
flap surgery outcomes (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 8 Jun 2022.