RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BANGALORE
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. Name of the Candidate and address(in block letters) / DR SANATH P.K.
THE “ FLOWERETTE” HOUSE
CDR.GEORGE MARTIS ROAD,
MALLIKATTE,KADRI,
MANGALORE
2. Name of the Institution / A J INSTITUTE OF MEDICAL SCIENCE
KUNTIKANA,
MANGALORE
575004.
3. Course of study and subject / M D DERMATOLOGY
4. Date of admission to course / 22-5-2012
5. Title of topic / CONTACT DERMATITIS IN HEALTH WORKERS OF A.J.INSTITUTE OF MEDICAL SCIENCES HOSPITAL.
6.0 Brief Resume of the intended Work :
6.1 Need for the study :
· To clinically evaluate healthcare workers presenting with hand eczema.
· To identify provoking allergens,if any,by patch testing with Indian standard series.
6.2 Review of Literature :
Contact dermatitis is an altered state of reactivity induced by
exposure to an external agent. It may be irritant or allergic in nature. Tissue damage by an allergic substance is mediated through immunologic mechanism. The most common clinical expression of this induced inflammation is dermatitis or eczema.
Hand eczema is a common and often, distressing skin condition due to its varied etiology, prolonged cause, remission and exacerbations and at times its resistant nature and special anatomical features of the palmar skin. The role of hands in everyday social life and work and the inability of the patient to comply fully with avoidance technique is also contributory.
Occupational skin disease (OSD) has been defined as "a pathological condition of the skin for which occupational exposure can be shown to be a major causal, or contributory factor".1
Occupational allergic contact dermatitis is an important medical and occupational health problem, which results from the exposure of worker to an allergen or irritant found in the workplace that comes into direct and indirect contact with the skin.2
The Association of National Health Occupational Physicians (ANHOPS)3 defines three categories of health care workers:
1. Clinical and other staff, including those in primary care, who have regular clinical contact with patients. This includes staff such as doctors, dentists, nurses, paramedical professionals such as occupational therapist, physiotherapist., radiographers, ambulance workers and students in this discipline.
2. Laboratory and other staff (including mortuary staff) who have direct contact with potentially infectious clinical specimens and may additionally be exposed to pathogens in the laboratory. This includes those in academics (or commercial research) and laboratories who handle clinical specimens. They do not have direct contact with patients.
3. Non clinical ancillary staff who may have social contact with patients, but not usually of a prolonged or close nature. This group includes receptionists, ward clerks, and other administrative staff working in hospital and primary care setting and maintenance staff such as engineers, gardeners, cleaners etc. These staff may be exposed to other specific occupational risks.
Health care workers are exposed to a vide variety of irritants, chemicals, biological and physical agents during their work. They get dermatitis from frequent hand washing with various harsh alkaline soaps, detergents and disinfectant solutions. Frequent washing produces a dry, fissured, pruritic dermatitis that readily becomes secondarily infected and eczematized. Younger women are most likely to have hand eczema4.
Atopy is also considered a significant risk factor for the development of hand eczema.4
6.3 Objectives of the study :
· Patch testing is an important investigation in patients with suspected contact dermatitis.
· It helps to confirm the presence of allergy and to identify the actual allergen.
· Patch testing done by Indian Standard Series contain allergens commonly used by healthcare workers.
· Identifying the allergenic ingredients or products by patch testing enables the dermatologist to advise the patients regarding the use of products. This enables the patient to avoid the allergens.
7.0 Material and Methods :
Heath care workers with hand dermatitis who attended the dermatology outpatient department of A J Institute of Medical Science , Mangalore during the period extending from JUNE 2012-JUNE 2014 were included in the study.
Test material
Patients will be tested with all the 20 antigens of the Indian standard series
INDIAN STANDARD BATTERY - PATCH TEST
SI,
No / Name / Result / SI.
No / Name / Result
1 / Vaseline / 17 / Wool alcohols
2 / Potassium Bichromate / 18 / Blackrubber mix
3 / Cobalt sulphate / 19 / Thiuram mix
4 / Neomycin sulphate / 20 / Formaldehyde
5 / Benzocaine
6 / Para-Phenylenediamine
7 / Parabens mix
8 / Nickel sulphate
9 / Colophony
10 / Plant antigens- Parthenium
11 / Perubalsam
12 / Epoxy Resin
13 / Fragrance mix
14 / Mercaptobenzothiazole
15 / Nitrofurazone
16 / Chlorocresol
Cases were selected based on following criteria
History
A detailed history regarding symptoms and cutaneous lesions will be taken and information about duration of use, frequency and precipitation or exacerbation of the dermatitis on exposure to allergen will be noted.
Examination
All patients will be subjected to detailed cutaneous examination which includes distribution and morphology of lesions and presence of secondary infection.
Patch testing
The kit comprises of microporous tape (15 x 15cm) and aluminium patch test chamber. Aluminium patch test chambers with an internal diameter of 9mm and a depth of 0.7mm were used. The test chambers were placed facing up with 2cm distance from centre of each other. It is stored at room temperature.
Procedure
· After explaining the procedure in detail, informed consent is taken.
· Allergens are taken out from refrigerator 15min before testing.
· After marking the top of patch test unit, protective foil is removed and patch test unit is placed on the table with aluminium chambers facing up.
· Fixing of the protective foil is done longitudinally along the edge of the patch test unit to facilitate handling.
· 2-3mm length of allergens from the syringe is put in the center of aluminium chambers. Excess of allergens was avoided.
· For aqueous or alcohol based allergens a fitter paper disc wet with a drop
of allergen is taken and placed on the aluminium chambers.
· The allergens were applied on the patch test unit.
· Upper back was cleaned gently with spirit but rubbing was avoided.
· The patch test units were taped on the back in vertical rows starting from
left scapular region upto right scapular area avoiding the vertebral column.
· The number and exact position of patch with number of allergen was
noted in the file.
The following instructions should be given to patients
1. Patch test must be left in place for two days.
2. Not to take bath or wash or wet the back during this period.
3. To avoid tight underclothes.
4. To avoid exercise or any other activity causing excessive sweating.
5. To avoid friction or scrubbing and lying on the back.
6. To avoid scratching the patch test sites and to report immediately if there is severe itching.
Time of Reading
All the patients should return after 48 hrs (2days) The patches will be removed and the reading should be taken 1 hours after the removal of patches.
Interpretation of Reactions :
All reactions will be graded according to the recommendation of the international Contact Dermatities Research Group (ICDRG )
+? - Doubtful reaction ; faint macular erythema only.
+ - Weak positive reaction; erythema, infiltration papules
++ - Strong positive reaction; erythema, infiltration, papulars, vesicles
+++ - Extreme positive reaction; intense erythema, infiltration and
coalescing vesicles.
- - Negative reaction
IR - Irritant reaction
NT - Not tested
The diagnosis of allergic contract dermatitis will be confirmed based on a positive patch test to an allergen.
7.1 Source of data :
Study will be done at A J Medical College Hospital
The study period is from 01-7-2012 to 31-11-2014.
7.2 Method of Collection of data :
Inclusion criteria
1. All health care workers with hand eczema.
Exclusion criteria
1. Pregnant and lactating women.
2. Patient on antihistamines, systemic steroids, immunomodulation or
irradiation therapy.
3. Patients with disseminated lesions were excluded from patch testing.
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals ? If so please describe briefly.
YES
7.4 Has ethical clearance been obtained from your institution in case of 7.3 ?
AWAITED
8.0 References :
1. Kucenic MJ, Beisito DV. Occupational allergic contact dermatitis is more prevalent than irritant contact dermatitis. J Am Acad Dermatol 2002;5:695-699.
2. Li LF, Sujan SA, Wang J. Detection of occupational allergic contact dermatitis by patch testing. Contact Dermatitis 2003;49: 189-193. .
3. Immunization of healthcare workers. ANHOPS; September 2001.
4. Rietschel RL, Fowler JF. Contact dermatitis in health personnel. In: Fisher's Contact Dermatitis, 5th edn. Philadelphia: Lippincott, Williams and Wilkins,2001:451 -465.
5. Lachapelle JM. Historical Aspects. In: Rycroft RJG, Menne' T, Frosch PJ, Lepoittenevin JP.eds. Textbook of Contact Dermatitis, 3"1 edn. Berlin: Springer, 2001:3-9.
6. Beck MH, Wilkinson SM. Contact dermatitis: Allergic. In: Burns T, Breathnach S, Cox N, Griffiths C, eds. Rook's Textbook of Dermatology, 7thedn. Oxford: Blackwell science Ltd, 2004;Vol.l :20.I -20.124.
7. Cronin E. Technique of patch testing. In: Contact Dermatitis, Edinburg: Churchill Livingstone, 1930:1-19
8. Lachapelle JM. Historical reflection and current problems in patch testing.In:Frosch PJ, Dooms-Goossens A, Lachapelle JM, Rycroft RJG, Scheper RJ, eds. Current topics in contact dermatitis. Verlag Berlin: Springer, 1989:50 - 56.
9.0 Signature of Candidate :
10.0 Remarks of the guide :
11.0 Name and Designation the: DR NARENDRA J SHETTY
of Guide ( in block letters) PROFESSOR
A J I M S ,MANGALORE
11.1 Signature:
11.2 Co-Guide (If any)
11.3 Signature
11.4 Head of the Department DR NARENDRA J SHETTY
11.5 Signature
12.0 Principal : DR RAMESH PAI
12.1 Remarks of the Principal
12.2 Signature
TIMELINE
TITLE : CONTACT DERMATITIS IN HEALTH WORKERS OF
A.J.INSTITUTE OF MEDICAL SCIENCES HOSPITAL.
Phase / Time Period / Activity1. / July - 2012 to
December – 2012 / 1. Idenification of the Problem
2. Review of literature
3. Preparing of Proforma
4. Pilot Study
5. Preparation and submission of synopsis
2. / January 2013
To
December 2013 / Collection of Data
3. / January 2014
To
November 2014 / Analysis and Discussion of collected data
Publication
From,
Dr.,SANATH P.K.
Post Graduate in Department of DERMATOLOGY
A.J. Institute of Medical Science
Mangalore
To,
The Registrar (Evaluation)
Rajiv Gandhi University of Health Sciences
Bangalore, Karnataka
(Through Proper Channel)
Sub:- Submission of Synopsis of Dissertation
Respected Sir,
Herewith, I am submitting synopsis of my dissertation work “CONTACT DERMATITIS IN HEALTH WORKERS OF A.J.INSTITUTE OF MEDICAL SCIENCES HOSPITAL.” for registration in M.D. (DERMATOLOGY )of A.J. Institute of Medical Science Mangalore. Kindly accept the same and oblige.
Thanking you.
Yours faithfully,
Place : Mangalore
Date : 14.10.2009
(Dr SANATH P.K)
Head of the Department
Dr NARENDRA J SHETTY
Prof. and Head, Department of
DERMATOLOGY
A.J. Institute of Medial Science
DEAN
A.J. Institute of Medical Science
Mangalore
CONSENT FOR PARTICIPATION IN RESEARCH
Purpose of study:
Procedure:
Risks:
No life threatening risks involved in the study.
Benefits:
Prospective study to compare the incidence of CONTACT DERMATITIS IN HEALTH WORKERS OF A.J.INSTITUTE OF MEDICAL SCIENCES HOSPITAL.
Alternatives:
Even if you decide not to participate in the study you will receive usual Standard care
Privacy and Confidentiality:
The results of the study may be published for scientific purposes and / or to
scientific groups. However you will not be identified. Privacy and confidentiality of the study participants will be ensured.
Institutional Policy
The A. J. Institute Of Medical Sciences will provide, within the limitations of the laws of the State of Karnataka, facilities and medical attention to subject who suffer injuries as a result of participating in its projects. In the event you believe that you have suffered any physical injury as result of your participation in this study you may contact Principal Investigator Dr SANATH P.K or DR NARENDRA J SHETTY Guide.
Financial incentive for participation:
You will not receive any payment for participating in this study.
Authorisation to publish results:
Results of this study may be published for scientific purposes or presented to scientific groups; however you will not be identified. No indefinable information will be used for publication or dissemination of the study finding. Only, DR NARENDRA J SHETTY Guide. and Dr SANATH P.K. Post graduate student A.J.Institute Of Medical Sciences, Mangalore-04 ,will have access to the data.
Contacts:
If you have any question about the research you may please contact Dr. Ramesh Pai, Principal and Chairman of Ethical Committee, A.J.Institute Of Medical Sciences, Mangalore-04. In case of any emergency you may contact, Dr SANATH P.K.Post Graduate Student, Dept Of DERMATOLOGY A.J.Institute Of Medical Sciences, Kuntikana ,Mangalore- 04, Telephone no. 9035949770 or DR NARENDRA J SHETTY Guide Professor, A.J.institute Of Medical Sciences, Mangalore
Your decision whether or not to participate in the study will not affect the standard care during your current or future relations with the hospital. You are free to discontinue the study at any time and for any reason.
Statement of consent
I volunteer and consent to participate in the study. I have read the consent or it has been read to me. The study has been fully explained to me and I may ask questions at any time.
______
Signature or left hand thumb impression of Patient Date
______
Signature of investigator / designee obtaining informed consent Date
______
Signature (Witness) Date
PROFORMA
Case No :
Hospital No :
Name :
Hospital :
Age :
Date :
Sex :
Address :
Occupation
1. Presenting complaints
2. Duration
3. Site of involvement
4. Associated symptoms – itching / pain / stinging / burning / oozing
Compound / Duration of use / Frequency ofuse / Exacerbation and ppt of dermatitis
a. Antiseptic
i, Sterillium
ii, Savlon
iii. Dettol
iv. Others
b. Detergents
i. Soap solution
ii. Phenyl
iii. Vim
iv. Bleaching agent
c. Rubber gloves
d. Others
5. History of atopy or asthma
6. Other known allergy
7. Past history of adverse reaction following any compound