RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BANGALORE
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. / NAME OF THE CANDIDATEAND ADDRESS / : / Dr. MITA D. WADEKAR
POSt GRADUATE STUDENT
department of microbiology
Mysore Medical college and Research Institute,
Mysore – 570 021.
2. / NAME OF THE INSTITUTION / : / MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, MYSORE
3. / COURSE OF STUDY AND
SUBJECT / : / M.D. (MICROBIOLOGY)
4. / DATE OF ADMISSION TO
THE COURSE / : / 30th JUNE 2010
5. / TITLE OF THE TOPIC / : / “BACTERIOLOGICAL
STUDY OF CHRONIC OSTEOMYELITIS AND THEIR ANTIBIOGRAM”
6. BRIEF RESUME OF THE INTENDED STUDY
6.1 NEED FOR THE STUDY
Infection of bone by microorganisms is called osteomyelitis.1 It is a disease of antiquity and is one of the most difficult to treat.2
Osteomyelitis develops from hematogenous spread of an infectious agents, invasion of bone tissue from adjacent site of infection, breakdown of tissue by trauma or surgery. Once established, infection may tend to progress towards chronicity, particularly if effective blood supply to the affected area is lacking.3
Staphylococcus aureus is the most common organism isolated (43%). Other organisms isolated were Pseudomonas aeruginosa (10%), Proteus species (6%), Klebsiella species (5%), E.coli (5%), Enterobacter species (3%), Staphylococcus epidermidis (4%), Streptococcus pyogenes (2%) and Enterococcus species (2%).4
Pus culture may yield the causative organism. This is useful for control of acute stage or may help in selecting the preoperative antibiotics.1
In the absence of early diagnosis and prompt treatment or failure of antibiotic therapy due to development of drug resistance, osteomyelitis is still an important cause of high morbidity.4
In selecting specific antibiotics for the treatment of osteomyelitis, type of infection, current hospital antibiotic susceptibility patterns and the risk of adverse reactions must be strongly appraised.5
Hence, the present study is conducted to determine the bacterial causes of chronic osteomyelitis and their antibiotic susceptibility pattern.
6.2 REVIEW OF LITERATURE
· R.D. Char, N.S. Brara, K.D. Khare et al. (1975) conducted a study on 27 patients of chronic osteomyelitis at Base and Command Hospital, Lucknow and concluded that out of 27 patients, 19 had positive culture for Staphylococcus pyogenes, 1 for Proteus. In 2 patients there was no record of pus culture. Of the remaining 6 patients, 4 had burnt out lesions and 2 had no sinuses and were treated conservatively. The Staphylococcus was resistant to penicillin in 14 out of 19 cases. In the other 5 cases it was sensitive to penicillin.7
· Augsburg J (1981) studied on pathogens and their antibiogram of 79 patients of osteomyelitis at Zentralbl Chir, German and concluded that monoinfection was present in 66% of patients. The still dominant role of Staphylococcus aureus could be confirmed, but also the increasing number of gram negative bacteria. Pseudomonas aeruginosa was the most frequent gram negative bacteria. On an average gentamycin was effective in 95% of patients.6
· A.K. Ako-Nai, I.C Ikem, A.Aziba et al. (2003) conducted a study on bacteriological examination of chronic osteomyelitis cases in ILE-IFE, Southwestern Nigeria and concluded that Staphylococcus species constituted 20.5%, coagulase negative staphylococci 12.8% and Streptococcus species 1.2%. Gram negative bacteria constituted 55.1% with Pseudomonas aeruginosa being 8.5%, Escherichia coli 5.1%, Citrobacter freundii and Salmonella species 2.5% each. Antibiotic susceptibility test revealed all isolates to be multiresistant to traditional antimicrobials.8
· Saurabh Agarwal, Mohd Zahid, Mohd K.A et al. (2005) conducted a study on 62 patients of chronic osteomyelitis for comparison of the results of sinus track culture and sequestrum culture at Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, India and concluded that Staphylococcus aureus was the most common organism isolated in both sinus track cultures and sequestrum cultures. Other organisms isolated were Streptococcus, Pseudomonas, Proteus, E.coli and Klebsiella.12
· Kaur J, Gulati VL, Aggarwal A, Gupta V (2008) conducted a study on 100 patients admitted in tertiary care and teaching hospital in North India to determine bacteriological profile of osteomyelitis with special reference to Staphylococcus aureus and concluded that Staphylococcus aureus (43%) was the most common bacterial cause and for coverage of gram negative bacteria, beta lactam + beta lactamase inhibitor combination was useful.4
· Alok.C.Agarwal, Shuddhatma Jain, R.K. Jain et al. (2008) conducted a retrospective study on 22 patients of chronic osteomyelitis at department of orthopaedics and traumatology, Netaji Subhash Chandra Bose Medical College and Hospital, Jabalpur, M.P, India to determine the pattern of bacterial infection and sensitivity to various antimicrobial agents in an various orthopaedic illnesses and concluded that out of 22 patients, 5 were due to Staphylococcus aureus, 1 due to Streptococcus, 1 due to Klebsiella, 8 due to E.coli and 7 were due to Pseudomonas.9
· Sheehy SH, Atkins BA, Bejon P et al. (2010) performed a prospective study of 166 patients from oxford, UK to describe the microbiological spectrum of chronic osteomyelitis and its prevalence of resistance to common empirical antimicrobial regimens. Staphylococcus aureus was most commonly isolated (32%) amongst a wide range of organisms including gram negative bacilli, anaerobes and coagulase negative staphylococci and many isolates were found to be resistant to commonly used empirical antimicrobial regimens.10
6..3 AIMS AND OBJECTIVES
1. To determine the bacteriological profile of chronic osteomyelitis.
2. To know the antibiotic susceptibility pattern of the isolates.
7. MATERIALS AND METHODS
7.1 Source of Data
The study will be conducted on patients of chronic osteomyelitis irrespective of age and sex admitted to K.R. Hospital, Department of orthopaedics, Mysore Medical College and Research Institute, Mysore.
The study will be undertaken for a period of 1 year from January 2011 to December 2011.
7.2 METHOD OF COLLECTION OF DATA
Pus sample by using 2 sterile cotton swabs will be collected from patients of chronic osteomyelitis. One swab is used for preparation of a smear for Gram’s stain. Other is inoculated onto MacConkey and Blood agar plates. The plates will be incubated at 370C for 18-24 hours in an aerobic incubator. Culture isolates will be identified by colony characteristics, Gram’s staining, motility and biochemical reactions.11
After identification antibiotic susceptibility testing will be done by Kirby-bauer disc diffusion method.
7.3 INCLUSION CRITERIA
All the patients of chronic osteomyelitis irrespective of age and sex admitted to K.R. Hospital, Department of orthopaedics, Mysore Medical College and Research institute, Mysore during the study period of January 2011 to December 2011 are included for study.
Bacterial organisms isolated from patients of chronic osteomyelitis will be included for the study.
7.4 EXCLUSION CRITERIA
Patients other than chronic osteomyelitis and causes other than bacterial organisms will be excluded from the study.
7.5 Does the study require any investigation/ intervention to be conducted on patiENTS OR other humans or animals? If so, please describe briefly.
No.
7.6 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.5?
Yes obtained (copy enclosed)
8. LIST OF REFERENCES
1. J. Maheshwari. Essential orthopaedics, 3rd edition (revised), New Delhi, Mehta Publishers, 2006 July; 157-163.
2. Gerald L. Mandell, John. E. Bennett, Raphael Dolin. Mandells, Douglas and Benett’s principles and practice of infectious diseases, 6th edition, Philadelphia, Elsevier Churchill Livingstone, 2005; 1: 1322-1330.
3. Betty A. Forbes, Daniel F. Sahm, Alice S. Wissfeld. Bailey and Scott’s diagnostic microbiology, 12th edition, China, Mosby Elsevier, 2007; 908-913.
4. Kaur J, Gulati VL, Aggarwal A, Gupta V. Bacteriological profile of osteomyelitis with special reference to Staphylococcus aureus. Indian Journal for the Practising Doctor 2008; vol. 4, No.6.
5. Mader JT, Shirtliff ME, Bergquist SC, Calhoun J. Antimicrobial treatment of chronic osteomyelitis. Clinical Orthopaedics and Related Research 1999 Mar; (360): 47-65.
6. Augsburg J. Chronic osteomyelitis, its pathogens.Analysis of 79 cases. Zentralbl Chir 1981; 106(7): 449-54.
7. R.D. Char, N.S. Brara, K.D. Khare et al. Chronic Osteomyelitis- its presentation and management. Indian Journal of Orthopaedics 1975 Dec; Vol.9, No.2: 95-100.
8. A.K. Ako-Nai, I.C. Ikem, A.Aziba et al. Bacteriological examination of chronic osteomyelitis cases in ILE-IFE, Southwestern Nigeria. African Journal of Clinical and Experimental Microbiology 2003; 4(2): 41-51.
9. Alok. C. Agarwal, Shuddhatma Jain, R.K. Jain et al. Pathogenic bacteria in an orthopaedic hospital in India. J Infect Developing Countries 2008; 2(2): 120-123.
10. Sheehy SH, Atkins BA, Bejon P et al. The microbiology of chronic osteomyelitis: prevalence of resistance to common empirical anti-microbial regimens. J infect 2010 May; 60(5): 338-43.
11. J.G. Collee, A.G. Fraser, B.P. Marmion, A. Simmons. Mackie and McCartney Practical Medical Microbiology, 14th edition. Churchill Livingstone, 2008; 67-71.
12. Saurabh Agarwal, Mohd Zahid, Mohd K.A. Sherwani et al. Comparison of the results of sinus track culture and sequestrum culture in chronic osteomyelitis. Acta Orthopaedica Belgica 2005; Vol. 71-2: 209-212.
9 / Signature of the candidate / (Dr. MITA D. WADEKAR)10 / Remarks of the guide
11 / Name And Designation of
(in block letters)
11.1 Guide / Dr. D. VENKATESHA, M.D. PROFESSOR AND HEAD DEPARTMENT OF MICROBIOLOGY MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, MYSORE
11.2 Signature
11.3 Head of the Department / Dr. D. VENKATESHA, M.D. PROFESSOR AND HEAD DEPARTMENT OF MICROBIOLOGY MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, MYSORE
11.4 signature
12 / 12.1 Remarks of the
Director & Dean
12.2 Signature
ETHICAL COMMITTEE CLEARANCE
AND their ANTIBIOGRAM
2. / Name of the Candidate / : / Dr. MITA D. WADEKAR
3. / Subject / : / M.D. (MIcrobiology)
4. / Name of the Guide / : / Dr. D. VENKATESHA, M.D.
Professor and Head
Department of Microbiology
Mysore medical College
and Research Institute,
Mysore.
5. / Approved / Not Approved
(If not approved, suggestion) / :
Superintendent SUPERINTENDENT
K.R. Hospital Cheluvamba Hospital
Mysore. Mysore.
PROFESSOR AND HOD Professor and HOD
Department of Medicine Department of General Surgery
Mysore Medical College Mysore Medical College
and Research Institute and Research Institute
Mysore Mysore.
SUPERINTENDENT Law expert
PKTB Hospital
Mysore
dean and DIREctor
Mysore Medical College and Research Institute
Mysore.
INFORMED CONSENT FORM
Topic title : Bacteriological Study of Chronic Osteomyelitis and Their Antibiogram.
Principle Investigator : Dr. MITA D. WADEKAR
Guide : Dr. D. VENKATESHA, M.D.
Professor and Head
Department of Microbiology
Mysore Medical College
and research Institute,
Mysore.
Location of study : Mysore Medical College and Research Institute
Mysore, Karnataka, India
MEDICAL INVESTIGATOR’S COMMITMENT
I, hereby state that the participant has been counselled about the implications of the study and the details regarding the study and questionnaire have been explained to the candidate in English/ Kannada languages as desired by the candidate and the participant has been given his/ her free and informed consent for the study.
I, the post-graduate will do everything possible to assure that the consent for the study session will be kept inapparent and confidential.
Date : Signature of the Student
Place : [Dr. MITA D. WADEKAR]
PARTICIPANT’S INFORMED CONSENT
I Mr / Mrs have been explained about the purpose of the above stated study, the procedures, possible benefits, and the maintenance of my confidentiality by the Investigator and I voluntarily participate in the study. My signature below attests this.
Date : Participant’s signature/ Thumb impression
Place:
Participant’s name:
Proforma
BACTERIOLOGICAL STUDY OF CHRONIC OSTEOMYELITIS
AND their ANTIBIOGRAM
Case No. : OP/IP No. :
Name of the patient : Ward :
Age : Unit :
Sex : Male/Female Date of admission :
Occupation : Date of discharge :
Address :
Chief complaints :
Yes/No
· Fever
· Pain
· Weight loss
· Non healing ulcer
· Sinus tract drainage
· Chronic fatigue and malaise
Past History :
· H/O trauma
· H/O any previous surgical procedures
· H/O Diabetes mellitus
Treatment history :
Socio-economic status : Low/Middle/Higher
Provisional diagnosis :
Laboratory diagnosis :
For Lab use only
Lab No. :
Date of collection :
Macroscopic :
Microscopic :
Culture :
Biochemical reactions :
Antibiotic susceptibility pattern :
Other investigations if any :
Signature
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