SARS-CoV-2 InfectionNCT06330389
Burn Injuries During COVID-19 Pandemic and Its Influence on Length of Stay
An observational study of SARS-CoV-2 Infection, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
Burn injuries were thought to be difficult to treat during the new corona virus epidemic. Our goal is to determine the risk factors that influence length of hospital stay (LOS) of burn injured patients during COVID -19 pandemic. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- Burn Injuries Graft Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteQatar
- Study dates
- 1 Apr 2020to 25 Jun 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had the burn graft surgery at Al Wakrah Hospital; Hamad Medical Corporation between from 1st of April to end of November 2020. Planned number will include all COVID-19 positive and negative.
Who may be able to join
- All burn injuries required surgery with COVID-19 positive or negative status
Who cannot join
- Other surgery during COVID-19 pandemic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anesthetic Experience and Patients 'Prognosis of SARS-CoV-2 Positive Versus Negative Burns Patients: An Observational Case -Control Study
Burn injuries were thought to be difficult to treat during the new corona virus epidemic. Our goal is to determine the risk factors that influence length of hospital stay (LOS) of burn injured patients during COVID -19 pandemic.
Read the detailed description
- Introduction / History
The world is being attacked by the rapidly expanding severe acute respiratory syndrome coronavirus-2 (SARS-Cov-2) epidemic, which is exacerbating an economic crisis. SARS-Cov-2 is the cause of the coronavirus disease 2019 (COVID-19). Anaesthetists are at risk for contracting a virus while doing their regular duties because they frequently come into touch with respiratory droplets.
All nations have put protective and preventive measures in place, forcing people to spend more time at home. A Brazilian study discovered that during the COVID-19 pandemic period, spending more time at home increased exposure to sanitizing products, which include ethanol and hydrogen peroxides that can cause burn injuries.
Aim of our Study:
Our goal is to determine the risk factors that influence length of hospital stay (LOS) of burn injured patients during COVID -19 pandemic.
Inclusion Criteria:
Patients who had the burn graft surgery at Al Wakrah Hospital; Hamad Medical Corporation between from 1st of April to end of November 2020. Planned number will include all COVID-19 positive and negative subjects in this period.
Data Source The electronic medical record (Cerner) used in order to identify patients who match study defined criteria. The investigators can Collect data directly from Cerner to excel sheet
Variable Abstraction Patient demographic and clinical data will be collected including age, morbidities, presenting symptoms, physical examination, laboratory investigations, intraoperative data, type of surgery, postoperative course, survival, and length of hospital stay and follow up.
In addition, the type of anesthesia is also included as factor for further complications ex general anesthesia, spinal or combined spinal epidural type.
Observation full reviewing of their medical illness and chart laboratory and investigations will be collected after getting approval of MRC and IRB committee.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- Burn Injuries Graft Surgery
- Keywords
- SARS-CoV-2, burn, outcome, Perioperative, Length of stay
- Medical subject headings
- COVID-19, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Burn Injuries Graft SurgeryProcedure or surgery
Burn Injuries Graft Surgery
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Positive and Negative status | Burn injuries with COVID-19 Positive and Negative status underwent surgery Receives: Procedure: Burn Injuries Graft Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Our goal is to determine the risk factors that influence length of hospital stay (LOS) of burn injured patients during COVID -19 pandemic.
Our goal is to determine the risk factors that influence length of hospital stay (LOS) of burn injured patients during COVID -19 pandemic.
Measured: 60-90 days
Secondary outcomes (1)
Clinical diffreneces between burn injuries with positive vs negative COVID-19 status
Details for those risk Factors: BMI; Pre Op Lab data, Intra Op data ex. blood loss / ml, transfusions/ ml or Unit , surgery time/ min, etc, Post operative data and ICU admission data, , lab parameters, INR,LFTs/unit , required blood transfusions/ml or Unit , re intubation times, vasopressor needs. Analyze lab values /unit, check number of days in hospital stay and ICU stay .
Analyze risk factors which affect hospital length of stay. Analyze risk factors using cox regression and investigate hazard ratio for each one to determine which is independent risk factor OR associated factor.
Measured: 60-90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 Apr 2020
- Primary completion1 Mar 2021
- Study completion25 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330389
- Sponsor's protocol ID
- MRC-01-20-1074
- Status last verified
- Jun 2021
- First submitted
- 4 Aug 2021
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Experience and Patients 'Prognosis of SARS-CoV-2 Positive Versus Negative Burns Patients: An Observational Case -Control Study
- ClinicalTrials.gov ID
- NCT06330389
- Acronym / sponsor ID
- MRC-01-20-1074
- Conditions
- SARS-CoV-2 Infection
- Keywords
- SARS-CoV-2, burn, outcome, Perioperative, Length of stay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 26 Mar 2024 (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.
Burn injuries were thought to be difficult to treat during the new corona virus epidemic. Our goal is to determine the risk factors that influence length of hospital stay (LOS) of burn injured patients during COVID -19 pandemic.
Detailed description
- Introduction / History
The world is being attacked by the rapidly expanding severe acute respiratory syndrome coronavirus-2 (SARS-Cov-2) epidemic, which is exacerbating an economic crisis. SARS-Cov-2 is the cause of the coronavirus disease 2019 (COVID-19). Anaesthetists are at risk for contracting a virus while doing their regular duties because they frequently come into touch with respiratory droplets.
All nations have put protective and preventive measures in place, forcing people to spend more time at home. A Brazilian study discovered that during the COVID-19 pandemic period, spending more time at home increased exposure to sanitizing products, which include ethanol and hydrogen peroxides that can cause burn injuries.
Aim of our Study:
Our goal is to determine the risk factors that influence length of hospital stay (LOS) of burn injured patients during COVID -19 pandemic.
Inclusion Criteria:
Patients who had the burn graft surgery at Al Wakrah Hospital; Hamad Medical Corporation between from 1st of April to end of November 2020. Planned number will include all COVID-19 positive and negative subjects in this period.
Data Source The electronic medical record (Cerner) used in order to identify patients who match study defined criteria. The investigators can Collect data directly from Cerner to excel sheet
Variable Abstraction Patient demographic and clinical data will be collected including age, morbidities, presenting symptoms, physical examination, laboratory investigations, intraoperative data, type of surgery, postoperative course, survival, and length of hospital stay and follow up.
In addition, the type of anesthesia is also included as factor for further complications ex general anesthesia, spinal or combined spinal epidural type.
Observation full reviewing of their medical illness and chart laboratory and investigations will be collected after getting approval of MRC and IRB committee.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Positive and Negative status | – | Procedure: Burn Injuries Graft SurgeryBurn injuries with COVID-19 Positive and Negative status underwent surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had the burn graft surgery at Al Wakrah Hospital; Hamad Medical Corporation between from 1st of April to end of November 2020. Planned number will include all COVID-19 positive and negative.
Key inclusion criteria (1 listed)
- All burn injuries required surgery with COVID-19 positive or negative status
Key exclusion criteria (1 listed)
- Other surgery during COVID-19 pandemic
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 |
|---|---|---|
| Burn Injuries Graft SurgeryBurn Injuries Graft Surgery | Procedure or surgery | COVID-19 Positive and Negative status |
Primary outcome
Our goal is to determine the risk factors that influence length of hospital stay (LOS) of burn injured patients during COVID -19 pandemic.
Time frame: 60-90 days
Our goal is to determine the risk factors that influence length of hospital stay (LOS) of burn injured patients during COVID -19 pandemic.
1 secondary outcome
Clinical diffreneces between burn injuries with positive vs negative COVID-19 status
Time frame: 60-90 days
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 26 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 Infection, run by Hamad Medical Corporation at 1 site in Qatar.
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 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Our goal is to determine the risk factors that influence length of hospital stay (LOS) of burn injured patients during COVID -19 pandemic. (time frame: 60-90 days). 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 26 Mar 2024.