- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05409170
The Change of Clinical Features and Surgical Outcomes in Patients With Pressure Injury During the COVID-19 Pandemic: A Retrospective Study
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.
Study Overview
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- all patients who received debridement or flap-reconstruction surgery for Pressure injury at Wan Fang Hospital from January 2016 to December 2021.
Exclusion Criteria:
- Patients who underwent debridement or flap-reconstruction surgery across the pre-COVID and COVID periods were excluded from the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
flap surgery outcomes
Time Frame: from January 2016 to December 2021
|
complete wound healing, major and minor complications, and recurrence.
|
from January 2016 to December 2021
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WanFangW
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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