| CTRI Number |
CTRI/2021/12/038802 [Registered on: 21/12/2021] Trial Registered Prospectively |
| Last Modified On: |
29/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Accidental Splashes, Spillages And Needle Stick Injuries among health care workers in Minor and Major surgeries in Obstetrics And Gynecology department. |
|
Scientific Title of Study
|
Accidental Splashes, Spillages And Needle Stick Injuries In Obstetrical And Gynecological Procedures Among Health Care Workers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrANMOL MITTAL |
| Designation |
JUNIOR RESIDENT ACADEMIC |
| Affiliation |
AIIMS RISHIKESH |
| Address |
LABOUR ROOM
MAJOR AND MINOR OT
OBS AND GYNAE WARDS
OBS AND GYNAE DEPARTMENT
LEVEL 3
AIIMS RISHIKESH
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9810148371 |
| Fax |
|
| Email |
anmolmitz15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JAYA CHATURVEDI |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT |
| Affiliation |
AIIMS RISHIKESH |
| Address |
AIIMS RISHIKESH
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9810148371 |
| Fax |
|
| Email |
jaya_sunil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrANMOL MITTAL |
| Designation |
JUNIOR RESIDENT ACADEMIC |
| Affiliation |
AIIMS RISHIKESH |
| Address |
LABOUR ROOM
MAJOR AND MINOR OT
OBS AND GYNAE WARDS
OBS AND GYNAE DEPARTMENT
LEVEL 3
AIIMS RISHIKESH
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9810148371 |
| Fax |
|
| Email |
anmolmitz15@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
RISHIKESH, UTTARAKHAND |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DRANMOL MITTAL |
AIIMS RISHIKESH |
LABOUR ROOM
MAJOR AND MINOR OT
OBS AND GYNAE WARDS
OBS AND GYNAE DEPARTMENT
Dehradun
UTTARANCHAL |
9810148371
anmolmitz15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All Health care worker who got pricked, splash or spillage during obs and gynae procedures. |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ALL HCWS IN OBSTETRICS AND GYNAECOLOGY DEPARTMENT TO BE INCLUDED |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the rate of Accidental splashes, spillages and NSIs in Obstetrical and Gynaecological procedures (major and minor) among HCWs.
|
2 years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Outcome of accidental injuries through splashes, NSIs:
Among HCWs, which type of exposure occurred in which category of HCWs.
During which procedure, which type of exposure happened
Knowledge, attitude and practice of universal precautions among HCWs.
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="294"
Sample Size from India="294"
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)
|
01/01/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Will publish the data only after completion of study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Health-care workers (HCWs) are always at potential risk of occupational exposure (OE) to infectious blood and body fluids because of the environment in which they work. This can lead to the acquisition of blood-borne pathogens such as Human Immunodeficiency Virus (HIV), Hepatitis B and C which can be life-threatening. Needlestick injuries (NSIs) are common and have been recognized as one of the potential occupational hazards. The Centres for Disease Control and Prevention (CDC) estimates that each year 385,000 NSIs and other sharp related injuries are sustained by HCWs, an average of 1000 sharp injuries per day. Such events impose high psychological and financial burden on individuals, families and the society. Apart from sharp injuries, accidental splashes and spillages are also common occupational accidents reported in high risk speciality like Obstetrics and Gynaecology. The proposed study aims to assess if HCWs are aware of the risks of eye and facial splashes, NSIs during Obstetrical and Gynaecological procedures and enumerate the factors associated with high rates of splashes and NSIs. Further, it will be designed to assess the knowledge, attitude and practices among HCWs regarding such accidental occupational hazards. Also, through this study we will understand how important it is to report such accidental injuries in the hospital in order to assure an early intervention and follow up of injured person, preventing the spread of deadly blood borne pathogens.
|