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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05409170
Other study ID # WanFangW
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date May 31, 2022

Study information

Verified date June 2022
Source Taipei Medical University WanFang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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]. 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.


Recruitment information / eligibility

Status Completed
Enrollment 213
Est. completion date May 31, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
COVID
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University WanFang Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary flap surgery outcomes complete wound healing, major and minor complications, and recurrence. from January 2016 to December 2021
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