Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05422989
Other study ID # Upper Extremity Trauma
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2021
Est. completion date June 15, 2022

Study information

Verified date June 2022
Source Islamic University of Caza, Gaza, Palestine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. Additionally, also evaluate the obstacles in treating UET in Gaza during the COVID-19 pandemic.


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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date June 15, 2022
Est. primary completion date November 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 80 Years
Eligibility Inclusion Criteria: 1. UET ED/ surgical ward admission; 2. Signed informed consent form to participate in this study. Exclusion Criteria: - Inability to consent or refusal to participate.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
X-ray, CT
Just a diagnostic procedure to confirm the diagnosis

Locations

Country Name City State
Israel Islamic University of Gaza Gaza Palestine

Sponsors (1)

Lead Sponsor Collaborator
Islamic University of Caza, Gaza, Palestine

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Upper Extremity Trauma in the Gaza-Strip Analysis of the public health Characteristics of UET during COVID-19 Nine months
See also
  Status Clinical Trial Phase
Withdrawn NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Completed NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Booster Study of SpikoGen COVID-19 Vaccine Phase 3
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure