Upper Extremity InjuryNCT05422989
Public Health Risks and Characteristics of Upper Extremity Trauma During COVID-19
An observational study of Upper Extremity Injury and COVID-19, run by Islamic University of Caza, Gaza, Palestine at 1 site in Israel.
Trial summary
The aim of this study was to evaluate for the first time in the Gaza-strip the characteristics and incidence of Upper Extremity Trauma (UET) during the COVID-19 pandemic. The participants, investigated the characteristics of UET cases, and evaluated the UET primary medical-care. Read more about this study
- Who is it for?
- Ages 1 year to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Extremity Injury, COVID-19
- What is being tested?
- X-ray, CT
- How many people
- 88 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2021to 15 Jun 2022
- How long will I take part?
- 6 Months
- 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 1 year to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All Upper Extremity trauma who arrived to ED and need addmission to the surgical ward
Who may be able to join
- UET ED/ surgical ward admission;
- Signed informed consent form to participate in this study.
Who cannot join
- Inability to consent or refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Public Health Risks and Characteristics of Upper Extremity Trauma During COVID-19 in the Gaza Strip: A Prospective Observational Study
The aim of this study was to evaluate for the first time in the Gaza-strip the characteristics and incidence of Upper Extremity Trauma (UET) during the COVID-19 pandemic. The participants, investigated the characteristics of UET cases, and evaluated the UET primary medical-care. Additionally, also evaluate the obstacles in treating UET in Gaza during the COVID-19 pandemic.
Read the detailed description
Upper extremity trauma (UET) presenting to emergency departments (ED) incidence is rising. UET account for 20% to 40% of ED cases. UET affect daily function due to limited functionality of upper limb joints, nerves and muscles. The disability caused, affects psychological and social well-being, and major trauma may result in life changing long-term disability; Surgical site infection in UET is a possible cause of increased morbidity and mortality, leading to increased length of stay causing clinical and economic burden. UET in low income countries during armed conflict often causes a devastating decline in quality of life.
In the United States (U.S.), UET was estimated to be about 10% of all traumas, with 37.2 million cases, and estimated annual costs of 92 billion dollars; Over 2.7 million hand and wrist-related injuries/infections were presented to the ED nationwide; Pediatric nonballistic firearm UET cases in the U.S. represent a significant burden of disease. Electric scooters have also become an increasingly cause for UET. Interestingly, the current literature reflects a growing interest in sport related UET, as such sport related injuries may contribute to the growing incidence of UET worldwide.
The overall UET incidence among U.S. military personnel (n=214,993) was 15 per 1,000 person years (<1%); UET are a common cause of morbidity and disability affecting military readiness, and imposing an economic burden. According to the United Nations Office for the Coordination of Humanitarian Affairs 2019 report, 87% of about 7,500 injuries during 17 months were classified as UET; The report estimated that about 18.5% of the injured require specialized limb reconstruction treatment, with individual treatment costs up to US$ 40,000; Leaving the healthcare needs with a growing funding gap due to the high toll of UET.
UET reported during COVID-19 in the U.S. were significantly fewer in 2020 than in previous years; However, the odds of being admitted to the hospital when presenting with an UET were significantly greater. While traumatic injuries were less common during lockdowns, but the incidence of UET increased during COVID-19 quarantine in Italy. UET during COVID-19 quarantine was a predominantly male-disorder (over 60%)mostly due to domestic traumas.During other times, the affected population was younger and the most common mechanisms were sport and traffic-related injuries.
At the end of COVID-19 lockdowns a spike of UET incidence (158%) was reported in the United Kingdom due to young malesporting injuries predoninantly; Falls from <1.5 meters were the most common cause requiring surgical intervention. Additionally, UET operative volume increased during lockdowns in specialized trauma centers; and five types of behavior were identified as causes leading to those injuries that included (1) high-risk behavior and lawlessness, (2) virus-related suicidality , (3) lack of support due to social-distancing, (4) domestic renovations and carpentry, and (5) avoidance of health care facilities and delay in getting and treatment.
UET has a full spectrum of presentations ranging from simple lacerations and cellulitis to complex amputations and necrotizing infections As UET prevalence rises there is a need to develop evidence-based changes to facilitate better UET management. Currently there is no ideal classification for UET, and even less information is available regarding complex traumatic UET. A major dilemma is presented by UET that requiring choosing between limb salvage and amputation. Comorbidities, pre-injury function and social situation must be considered, as well as surgical considerations (as amputations may present more favorable functional and psychological prognosis compared to lengthy complex salvage surgeries with high risk of unfavorable complications). A viewpoint published in the midst of the COVID-19 pandemic stated that the public health infrastructural inadequacies led to a crisis in the Gaza-strip regarding sanitation, hygiene, waste treatment and water supply; Thus exposing Gaza's population to more epidemiological risks and disease outbreaks.
- Conditions
- Upper Extremity Injury, COVID-19
- Being tested
- X-ray, CT
- Keywords
- Upper Extremity Trauma
- Medical subject headings
- Arm Injuries, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-ray, CTDiagnostic test
Just a diagnostic procedure to confirm the diagnosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Upper Extremity Trauma in the Gaza-Strip
Analysis of the public health Characteristics of UET during COVID-19
Measured: Nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Feb 2021
- Primary completion30 Nov 2021
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity 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
- Prospective
- Enrolment
- 88 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Islamic University of Caza, Gaza, Palestine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Najlaa M Abu Jamie, Islamic University of Caza, Gaza, Palestine
- Investigators
- Mostafa Yassin, M.D, Study chair, Rabin Medical Center, Tel Aviv University School of Medicine, Israel.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422989
- Sponsor's protocol ID
- Upper Extremity Trauma
- Status last verified
- Jun 2022
- First submitted
- 15 Jun 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Public Health Risks and Characteristics of Upper Extremity Trauma During COVID-19 in the Gaza Strip: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05422989
- Acronym / sponsor ID
- Upper Extremity Trauma
- Conditions
- Upper Extremity Injury, COVID-19
- Keywords
- Upper Extremity Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Islamic University of Caza, Gaza, PalestineUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 21 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 aim of this study was to evaluate for the first time in the Gaza-strip the characteristics and incidence of Upper Extremity Trauma (UET) during the COVID-19 pandemic. The participants, investigated the characteristics of UET cases, and evaluated the UET primary medical-care. Additionally, also evaluate the obstacles in treating UET in Gaza during the COVID-19 pandemic.
Detailed description
Upper extremity trauma (UET) presenting to emergency departments (ED) incidence is rising. UET account for 20% to 40% of ED cases. UET affect daily function due to limited functionality of upper limb joints, nerves and muscles. The disability caused, affects psychological and social well-being, and major trauma may result in life changing long-term disability; Surgical site infection in UET is a possible cause of increased morbidity and mortality, leading to increased length of stay causing clinical and economic burden. UET in low income countries during armed conflict often causes a devastating decline in quality of life.
In the United States (U.S.), UET was estimated to be about 10% of all traumas, with 37.2 million cases, and estimated annual costs of 92 billion dollars; Over 2.7 million hand and wrist-related injuries/infections were presented to the ED nationwide; Pediatric nonballistic firearm UET cases in the U.S. represent a significant burden of disease. Electric scooters have also become an increasingly cause for UET. Interestingly, the current literature reflects a growing interest in sport related UET, as such sport related injuries may contribute to the growing incidence of UET worldwide.
The overall UET incidence among U.S. military personnel (n=214,993) was 15 per 1,000 person years (<1%); UET are a common cause of morbidity and disability affecting military readiness, and imposing an economic burden. According to the United Nations Office for the Coordination of Humanitarian Affairs 2019 report, 87% of about 7,500 injuries during 17 months were classified as UET; The report estimated that about 18.5% of the injured require specialized limb reconstruction treatment, with individual treatment costs up to US$ 40,000; Leaving the healthcare needs with a growing funding gap due to the high toll of UET.
UET reported during COVID-19 in the U.S. were significantly fewer in 2020 than in previous years; However, the odds of being admitted to the hospital when presenting with an UET were significantly greater. While traumatic injuries were less common during lockdowns, but the incidence of UET increased during COVID-19 quarantine in Italy. UET during COVID-19 quarantine was a predominantly male-disorder (over 60%)mostly due to domestic traumas.During other times, the affected population was younger and the most common mechanisms were sport and traffic-related injuries.
At the end of COVID-19 lockdowns a spike of UET incidence (158%) was reported in the United Kingdom due to young malesporting injuries predoninantly; Falls from <1.5 meters were the most common cause requiring surgical intervention. Additionally, UET operative volume increased during lockdowns in specialized trauma centers; and five types of behavior were identified as causes leading to those injuries that included (1) high-risk behavior and lawlessness, (2) virus-related suicidality , (3) lack of support due to social-distancing, (4) domestic renovations and carpentry, and (5) avoidance of health care facilities and delay in getting and treatment.
UET has a full spectrum of presentations ranging from simple lacerations and cellulitis to complex amputations and necrotizing infections As UET prevalence rises there is a need to develop evidence-based changes to facilitate better UET management. Currently there is no ideal classification for UET, and even less information is available regarding complex traumatic UET. A major dilemma is presented by UET that requiring choosing between limb salvage and amputation. Comorbidities, pre-injury function and social situation must be considered, as well as surgical considerations (as amputations may present more favorable functional and psychological prognosis compared to lengthy complex salvage surgeries with high risk of unfavorable complications). A viewpoint published in the midst of the COVID-19 pandemic stated that the public health infrastructural inadequacies led to a crisis in the Gaza-strip regarding sanitation, hygiene, waste treatment and water supply; Thus exposing Gaza's population to more epidemiological risks and disease outbreaks.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All Upper Extremity trauma who arrived to ED and need addmission to the surgical ward
Key inclusion criteria (2 listed)
- UET ED/ surgical ward admission;
- Signed informed consent form to participate in this study.
Key exclusion criteria (1 listed)
- Inability to consent or refusal to participate.
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 |
|---|---|---|
| X-ray, CTJust a diagnostic procedure to confirm the diagnosis | Diagnostic test | – |
Primary outcome
Incidence of Upper Extremity Trauma in the Gaza-Strip
Time frame: Nine months
Analysis of the public health Characteristics of UET during COVID-19
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 22 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Mostafa Yassin, M.D study chair
Rabin Medical Center, Tel Aviv University School of Medicine, Israel.
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 Upper Extremity Injury and COVID-19, run by Islamic University of Caza, Gaza, Palestine at 1 site in Israel.
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 2 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 22 Jun 2022. 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 Israel. 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?
Incidence of Upper Extremity Trauma in the Gaza-Strip (time frame: Nine months). 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 22 Jun 2022.