NCT05409170

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

5.9 years

First QC Date

June 7, 2022

Last Update Submit

June 7, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • flap surgery outcomes

    complete wound healing, major and minor complications, and recurrence.

    from January 2016 to December 2021

Study Arms (2)

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.

Procedure: COVID

Interventions

COVIDPROCEDURE

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.

covid group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the January 2016-December 2019 and January 2020-December 2021 intervals were defined as pre-COVID and COVID periods, respectively.

You may qualify if:

  • all patients who received debridement or flap-reconstruction surgery for Pressure injury at Wan Fang Hospital from January 2016 to December 2021.

You may not qualify if:

  • Patients who underwent debridement or flap-reconstruction surgery across the pre-COVID and COVID periods were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pressure UlcerCOVID-19

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
TMU-Joint Institutional Review Board

Study Record Dates

First Submitted

June 7, 2022

First Posted

June 8, 2022

Study Start

January 1, 2016

Primary Completion

December 1, 2021

Study Completion

May 31, 2022

Last Updated

June 8, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

The medical recoreds were saved in Wan Fang Hospital