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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Israel1 site
  • Islamic University of Gaza

    Gaza, Palestine, 0000

Other trials in Israel

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.

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.

  1. 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.

  1. First posted21 Jun 2022
  2. Study start1 Feb 2021
  3. Primary completion30 Nov 2021
  4. Study completion15 Jun 2022

Resources

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
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

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.

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