Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202011853914203 Date of Approval: 18/11/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of Implementation of Sequential Trauma Education Programs (STEPs) Course on Missed Injuries in Emergency Polytrauma Patients, Ismailia, Egypt
Official scientific title Impact of Implementation of Sequential Trauma Education Programs (STEPs) Course on Missed Injuries in Emergency Polytrauma Patients, Ismailia, Egypt
Brief summary describing the background and objectives of the trial Introduction: Trauma deaths account for 8% of all deaths in Egypt. Patients with multiple injuries are at high risk but may be saved with a good triage system and a well-trained trauma team in dedicated institutions. The incidence of missed injuries in the Emergency Department (ED) of Suez Canal University Hospital (SCUH) was found to be 9.0% after applying Advanced Trauma Life Support (ATLS) guidelines. However, this rate is still high compared with many trauma centers. Aim: Improve the quality of management of polytrauma patients by decreasing the incidence of missed injuries by implementing the Sequential Trauma Education Programs (STEPs) course in the ED at SCUH.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) STEPS
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 10/08/2019
Actual trial start date 10/08/2019
Anticipated date of last follow up 09/03/2020
Actual Last follow-up date 09/03/2020
Anticipated target sample size (number of participants) 458
Actual target sample size (number of participants) 458
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group No interventions No interventions just observations and follow up No interventions just observations and follow up for 48 hours No interventions just observations and follow up for 48 hours to detect missed injuries 125 Active-Treatment of Control Group
Experimental Group No direct interventions only training course for ED physicians and measure missed injuries No direct interventions only training STEPS course for ED physicians and measure incidence of missed injuries 6 months No direct interventions only training STEPS course for ED physicians and measure incidence of missed injuries 333
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. All ages 2. Both sexes 3. Patients with polytrauma criteria: • Death within 24 hours • ISS of 16 or more • ICU stay of 1 day or more • More than two units of blood transfusion 1. Patients transferred from other hospitals after undergoing any medical or surgical procedure 2. Patients discharged by his or her demand or transferred to another hospital 3. Patients with injuries that occurred more than 24 hours before presentation 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,Middle Aged: 45 Year(s)-64 Year(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 28 Day(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/09/2018 Suez Canal University
Ethics Committee Address
Street address City Postal code Country
Research ethic committee, Faculty of Medicine, Suez Canal University, Ismailia, Egypt Ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Decreasing the incidence of missed injuries through the implementation of the STEPs course in the SCUH ED. 48 hours
Secondary Outcome evaluate adherence to STEPS guidelines at emergency department of Suez Canal University. 48 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez Canal University. Suez Canal University hospitals Ismailia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institutes of Health Fogarty International Center Bethesda United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Suez Canal University Suez Canal University Hospitals Ismailia Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
University of Maryland 110 S. Paca Street, 6th Floor Baltimore United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adel Elbaih elbaihzico@yahoo.com +201154599748 Heraa street, Garden city shark
City Postal code Country Position/Affiliation
Ismailia Egypt Suez Canal University
Role Name Email Phone Street address
Public Enquiries Adel Elbaih elbaihzico@yahoo.com +201154599748 Heraa street,
City Postal code Country Position/Affiliation
Ismailia Egypt Suez Canal University
Role Name Email Phone Street address
Scientific Enquiries Adel Elbaih elbaihzico@yahoo.com +201154599748 Heraa street
City Postal code Country Position/Affiliation
Ismailia Egypt Suez Canal University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Overall, 45 patients were found to have missed injuries, of which 15 (12%) were pre-STEPs and 30 (9%) were post-STEPs course. The STEPs course significantly increased adherence to vital data recording, but the reduction of missed injuries (3.0%) was not statistically significant in relation to demographic and trauma findings. However, the decrease in missed injuries in the post-STEPs course group was an essential clinically significant finding. Informed Consent Form August 10, 2019 to March 9, 2020 STEPs course, Training programs, Trauma injuries
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not available Yes 15/11/2020 15/11/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 15/11/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information