| CTRI Number |
CTRI/2019/01/017033 [Registered on: 10/01/2019] Trial Registered Prospectively |
| Last Modified On: |
08/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To know the total number nurses having Allergic skin condition using patch testing in tertiary care hospital |
|
Scientific Title of Study
|
Prevalence of Allergic contact dermatitis using patch testing in nurses in tertiary care hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Skin&VD/03/2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arpita Arghya |
| Designation |
Junior Resident |
| Affiliation |
MGM Medical College and Hospital |
| Address |
skin and VD department, basement floor opd building MGM medical college and hospital
N6 cidco aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8904011332 |
| Fax |
02402487727 |
| Email |
arpitaarghya06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Deshmukh |
| Designation |
Professor and HOD |
| Affiliation |
MGM Medical College and Hospital |
| Address |
skin and VD department, basement floor opd building MGM medical college and hospital
N6 cidco aurangabad
Aurangabad
MAHARASHTRA
430013
India |
| Phone |
9422213292 |
| Fax |
02402487727 |
| Email |
ashish7557@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arpita Arghya |
| Designation |
Junior Resident |
| Affiliation |
MGM Medical College and Hospital |
| Address |
skin and VD department, basement floor opd building MGM medical college and hospital
N6 cidco aurangabad
Aurangabad
MAHARASHTRA
430013
India |
| Phone |
8904011332 |
| Fax |
02402487727 |
| Email |
arpitaarghya06@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM medical college and hospital
N6 cidco aurangabad |
|
|
Primary Sponsor
|
| Name |
MGM MEDICAL COLLEGE AND HOSPITAL |
| Address |
N6 cidco Aurangabad, Maharashtra |
| 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 |
| DrArpita Arghya |
MAHATMA GANDHI MISSIONS COLLEGE AND HOSPITAL |
256 Skin and VD department Basement floor MGM OPD building N6 CIDCO
Aurangabad
MAHARASHTRA |
7992355268
arpitaarghya06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM- ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L239||Allergic contact dermatitis, unspecified cause, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
57.00 Year(s) |
| Gender |
Both |
| Details |
1 All the nurses working in MGM Medical college and hospital, Aurangabad having hand eczema |
|
| ExclusionCriteria |
| Details |
1 Any active lesion present -erythema, vesicles, edema etc
2 Pregnant women
3 Lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prevalence of allergic contact dermatitis using patch testing in nurses in tertiary care hospital |
patient will be followed up after 48 hours followed by 96 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="326"
Sample Size from India="326"
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)
|
18/01/2019 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Prevalence studies reveal dermatitis is about 20% of the general population at one time. Hand dermatitis is present in about 2% of the people at any time with a lifetime risk of 20% in women. Contact dermatitis makes up to 80% of all occupational skin disease Nurses are at very high risk for dermatitis because of exposure to potential irritants, including glove wearing, alcohol rub use, hand washing with water and disinfectants. as the prevalence of allergic contact dermatitis is rapidly increasing among nurses, and there is lack of awareness among them with lack of many research done on nurses, it should be considered a priority with interventional strategies to reduce its prevalence.
Bajaj A K, Saraswat A, Mukhjia G, Rastogi S, Yadav S "Patch testing experience with 1000 patients " Indian J Dermatol Venerol Leprol 2007;73:313-8
Bhattarai S, Agarwal S, Rijal A." Clinical and contact allergolocial observation on Hand Eczema: A Descriptive study " Current allergy & clinical immunology 2014 Nepal Med Coll J 2014; 16(1): 37-41 |