| CTRI Number |
CTRI/2025/07/091481 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Observational study on occupational Injuries presenting to the emergency department |
|
Scientific Title of Study
|
A Prospective observational study on epidemiological profile and outcome of the occupational injuries presenting to emergency medicine department in a tertiary care centre |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alli Sai Deepak |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba medical college , Manipal |
| Address |
Department of emergency medicine , Kasturba medical college , Manipal ,Udupi ,Karnataka India
Udupi
KARNATAKA
576104
India |
| Phone |
7330754644 |
| Fax |
|
| Email |
deesindu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Alli Sai Deepak |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba medical college , Manipal |
| Address |
Department of emergency medicine , Kasturba medical college , Manipal ,Udupi ,Karnataka India
Udupi
KARNATAKA
576104
India |
| Phone |
7330754644 |
| Fax |
|
| Email |
deesindu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Alli Sai Deepak |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba medical college , Manipal |
| Address |
Department of emergency medicine , Kasturba medical college , Manipal ,Udupi ,Karnataka India
Udupi
KARNATAKA
576104
India |
| Phone |
7330754644 |
| Fax |
|
| Email |
deesindu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Emergency Medicine ,Kasturba Medical College ,MAHE ,Madhav Nagar ,Manipal ,UDUPI Udupi KARNATAKA India Pincode 576104 |
| NIL |
|
|
Primary Sponsor
|
| Name |
Department of Emergency Medicine Kasturba Medical College MAHE |
| Address |
Department of Emergency Medicine ,Kasturba Medical College ,MAHE ,Madhav Nagar ,Manipal ,UDUPI Udupi KARNATAKA India pincode 576104 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alli Sai Deepak |
Kasturba hospital |
Ground floor ,Department of Emergency Medicine ,Kasturba Medical College ,MAHE ,Madhav Nagar ,Manipal ,UDUPI
Udupi
KARNATAKA
Udupi
KARNATAKA |
7330754644
deesindu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kasturba medical college and kasturba hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients age greater than or equal to 18 years of age
2. Injury occurring at work place
|
|
| ExclusionCriteria |
| Details |
1. Patients who are not giving consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To calculate the percentage of patients with occupational injuries presenting to emergency department.
2. the most common presentation of the occupational injury presenting to Emergency department
3. To determine the outcome of the cases presenting with occupational injury to emergency department
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To determine the risk factors among the cases with occupational injury to emergency department |
1 year |
|
|
Target Sample Size
|
Total Sample Size="397"
Sample Size from India="397"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Occupational injuries are defined as any injury such as cut,sprain,laceration which results from work related event or from single exposure in work related event .they have significant burden on national and individual level. Rapid industrialization and urbanization lead to more occupational injuries in developing countries . Developing nations have more prone for occupational injury compared to developed nations.construction workers and electrical workers were more commonly presented with occupational injuries to emergency department . In rural India ,agricultural workers are more common presented to emergency department .Upper Limb and lower limb are most commonly affected in most of the cases.Higher working hours and lower training exposure are most common risk factors .This study includes the patients presenting to emergency department with alleged history of occupational injuries with age greater than or equal to 18 years .A detailed proforma containing socio demographic ,clinical data will be documented .Injuries will be assessed by multiple scoring system[ISS,TRISS,RTS].Risk factors,professional experience,safety practises at work place,outcome of the patients will be documented .Follow up of patients will be done during the discharge of patients from the hospital There is lack of data regarding the occupational injury presenting to emergency department in India.Data regarding the risk factors ,training of the workers ,safety practise at work helps in developing an policy and strategy for the nation on prevention of occupational injury.this study helps in identifying the risk factors ,profiling of patients which in turn help to develop a plan to reduce occupational injuries in the country
|