| CTRI Number |
CTRI/2017/10/010116 [Registered on: 16/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
13/10/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of Patterns, Causes and Effects of health condition following Hand injuries in the patients presenting to a Tertiary Care Centre. |
|
Scientific Title of Study
|
Epidemiological Study of Hand injuries in a Tertiary Care Centre |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prajwal K Rao |
| Designation |
Mch Plastic Surgery Resident |
| Affiliation |
AJ Institute of Medical Science and Research Centre |
| Address |
Dept of Plastic and Reconstructive Surgery,
AJ Institute of Medical Science and Research Centre,
Bejai, NH66,
Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9686691489 |
| Fax |
|
| Email |
pprajwalrao@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dinesh Kadam |
| Designation |
Professor and HOD |
| Affiliation |
AJ Institute of Medical Science and Research Centre |
| Address |
Dept of Plastic and Reconstructive Surgery,
AJ Institute of Medical Science and Research Centre,
Bejai, NH66,
Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9886312711 |
| Fax |
|
| Email |
drkadam@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dinesh Kadam |
| Designation |
Professor and HOD |
| Affiliation |
AJ Institute of Medical Science and Research Centre |
| Address |
Dept of Plastic and Reconstructive Surgery,
AJ Institute of Medical Science and Research Centre,
Bejai, NH66,
Mangalore
KARNATAKA
575004
India |
| Phone |
9886312711 |
| Fax |
|
| Email |
drkadam@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| A J Institute of Medical Sciences and Research Centre,
Dept of Plastic and Reconstructive Surgery,
NH 66, Kuntikana, Bejai, Mangalore, Karnataka. Pin 575004 |
|
|
Primary Sponsor
|
| Name |
A J Institute of Medical Sciences and Research Centre |
| Address |
Dept of Plastic and Reconstructive Surgery,
A J Institute of Medical Sciences and Research Centre,
NH66, Kuntikana, Bejai, Mangalore, Karnataka. Pin 575004 |
| 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 |
| Prajwal K Rao |
A J Institute of Medical Sciences and Research Centre |
A J Institute of Medical Science and Research Centre,
Dept of Plastic and Reconstructive Surgery,
Kuntikana, Bejai, NH66, Mangalore. Pin :575004
Dakshina Kannada
KARNATAKA |
9686691489
pprajwalrao@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| A J Institute of Medical Sciences and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with Hand injuries attending to A J Institute of Medical Sciences and Research Centre, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)All trauma patients with hand injuries who were admitted to A.J Institute of Medical Sciences and Research Centre, Mangalore for more than 24hours.
2)Patients willing to participate after filling consent form.
|
|
| ExclusionCriteria |
| Details |
1) Unwilling and uncooperative patients.
2) Burn Injuries of hand.
3) Hand injuries, older than 3 days.
4) Hand injuries who do not require any intervention.
5) Hand injuries not requiring admission.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the demography, epidemiological characteristics and risk factors of casualties suffering from hand injuries. |
Demography, Epidemiological characteristics and Risk factors of casualties suffering from hand injuries will be assessed on admission to hospital. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To describe the location, tissue damage and typical patterns of hand injury and to rate the severity of hand injuries caused by trauma and examine the possible relation between injury severity and mode of injury. |
Typical patterns of Hand injury and possible relation between injury severity and mode of injury attending to a Tertiary Care centre will be assessed on admission to hospital until discharge from hospital. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/01/2017 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hand injuries are common in young men, accounting for nearly one fifth of the hospital emergency visits. Hand is at risk of injury from number of causes ranging from road traffic injuries to occupational hazards to sporting activities to domestic injuries. The economic, social, physical and psychological impact is tremendous. It is essential to restore normal function and also give a normal appearance following surgical treatment for hand injuries.
The purpose of this study is to know the epidemiology of the hand injuries, the various causes, the pattern of injuries which are presenting to our hospital. We believe this study will help to get information on demography and risk factors for hand injuries related to the individual, the environment and the equipment in order to allow the development of efficient injury prevention and safety promotion.
|