SYNOPSIS

COMPLICATIONS AND MANAGEMENT OF HAND INFECTIONS

SYNOPSIS SUBMITTED FOR APPROVAL BY ETHICAL COMMITTEE BY

DR. AJIT MISHRA FOR BRANCH MS (GENERAL SURGERY)

DOCUMENTS FOR DISSERTATION

CHECK-LIST ENCLOSURES (DISSERTATIONS)

For submission of Research proposal to Ethics Committee of B.J.M.C. and S.G.H. Pune

1] 2]

Cover Page (Appendix 1) Check-List Enclosures (Dissertations) 1. Research Proposal (Appendix 2) 1. a Part I General Information 1. b Part II One page executive summary sheet 1.c Part III - Details of Research Proposal 2. Inform Consent (Appendix 3) 2. a English 2. b Marathi 2. c Hindi 3. Application for Permission for Animal Experiments (Appendix 4) 4. PI undertaking (Appendix 5) 5. Certificate from HOD (Appendix 6)

-----------------------------------------------------------------------------Research proposal should be submitted in A) Hard copy: i. e. Print outs One Copy only B) Soft Copy: On C D /DVD; Preferably in *.pdf format OR in Word document format

Appendix 1:

Cover Page (for Dissertations) For submission of Research proposal to Ethics Committee of B.J.M.C. and S.G.H. Pune

1. Full Name of PG Student: Dr. MISHRA AJIT MATAPRASAD 2. Department: SURGERY 3. Candidate admitted in the year: 2011 4. Course and subject: SURGERY 5. College Name & Address: B.J.MEDICAL COLLEGE, PUNE. 6 Title of Research Project topic: COMPLICATIONS AND MANAGEMENT OF HAND INFECTIONS 7. Full name of P.G. Guide :Dr. SHAILAJA P. JADHAV 8. Contact phone number of PG Student: 9324381753

Appendix 2: Research Proposal For submission of Research proposal to Ethics Committee of B.J.M.C. and S.G.H. Pune PART I : GENERAL INFORMATION 1. TITLE OF THE PROJECT : COMPLICATIONS AND MANAGEMENT OF HAND INFECTIONS

2. NAME AND DESIGNATION OF : a) Postgraduate Guide: DR.SHAILAJA P. JADHAV

PROFESSOR DEPT OF SURGERY B.J.MEDICAL COLLEGE, PUNE.

b)

Postgraduate Student: Dr. MISHRA AJIT MATAPRASAD

RESIDENT DEPT OF SURGERY B.J.MEDICAL COLLEGE, PUNE.

3. DURATION OF THE PROJECT : a) b) c) d) Period that may be required for data collection : 2 YEAR Deadline for collecting data : JUNE2013 Period that may be required for analysis of data : 6 MONTHS Deadline for analysis of data : DEC 2013

4. DEADLINE FOR SUBMISSION OF THE

DISSERTATION TO THE UNIVERSITY

: DEC 2013

5. REVIEW OF PROGRESS : Reviews 1st quarter Review of progress of project Review of collection of data Review of analyzed data 2nd quarter 3rdquarter

6. SIGNATURES :

a)

Postgraduate student :

b)

Postgraduate guide :

c)

Head of dept, Dept of surgery, B.J.Medical college, pune.

d)

Head of dept, Dept of Radiodiagnosis,, B.J.Medical college, pune

e)

Head of dept , Dept of surgery, B.J.Medical college, pune

7. a) Date of submission to ethical committee : b) Date of clearance of the committee: c) Remarks of the secretary:

PART II :ONE PAGE EXECUTIVE SUMMARY SHEET

1) Title of the Project:- COMPLICATIONS AND MANAGEMENT OF

HAND INFECTIONS 2) Name of the PG guide:- DR. SHAILAJA P. JADHAV 3) Name of the PG Student:- DR. MISHRA AJIT MATAPRASAD 4) Name of the Department:- SURGERY 5) Name of the Institute:- B.J.MEDICAL , PUNE.

6) Aims & Objectives: Early diagnosis and management of various hand infections Early detection of complications of hand infections and their management Preserve optimal function of hand following infection

7) Introduction:. Few structures of the body are as complex or as unique as the human hand with the functions of sensation, mobility, and strength in one small area. The hand consists of multiple compartments and planes, the knowledge of which allows one to understand the pathophysiology, diagnosis, and treatment of hand infections The hands compartmentalized anatomy is one of the reasons why the hand is more prone to infections. Seemingly simple infections of the hand can more often result in debilitating conditions and significant morbidity. The hand being one of the more important functional organs required in day to day physical activities, it becomes important that such morbid conditions should be diagnosed

and treated effectively at an early stage so that the function of the hand can be well preserved. If an infection is not appropriately diagnosed and treated, significant morbidity can result.

8) Material & Methods:Sample size- All cases admitted between period June 2011 June 2014 Number of cases- 25 Type of study- Prospective Duration of study:- 2 years

9) Risks Involved:- This is not an interventional study so complications related to

procedure and anesthetic complications are the only risk involved in this study.

PART III : DETAILS OF RESEARCH PROPOSAL

COMPLICATIONS AND MANAGEMENT OF HAND INFECTIONS

1. TITLE OF THE PROJECT :

2. AIMS AND OBJECTIVES Early diagnosis and management of various hand infections Early detection of complications of hand infections and their management Preserve optimal function of hand following infection

3.

INTRODUCTION (Background information)

Few structures of the body are as complex or as unique as the human hand with the functions of sensation, mobility, and strength in one small area. The hand consists of multiple compartments and planes, the knowledge of which allows one to understand the pathophysiology, diagnosis, and treatment of hand infections The hands compartmentalized anatomy is one of the reasons why the hand is more prone to infections. Seemingly simple infections of the hand can more often result in debilitating conditions and significant morbidity. The hand being one of the more important functional organs required in day to day physical activities, it becomes important that such morbid conditions should be diagnosed and treated effectively at an early stage so that

the function of the hand can be well preserved. If an infection is not appropriately diagnosed and treated, significant morbidity can result.
A thorough understanding of hand and finger anatomy and knowledge of the bacteria commonly involved in infections of the upper extremity are required of the surgeon who will be caring for these patients. An understanding of the fascial boundaries of the hand will help to identify the extent of the infection and plan surgical incisions. Host factors, location, and circumstances of the infection are important guides to initial treatment strategies. Many hand infections improve with early splinting, elevation, appropriate antibiotics and, if an abscess is present, incision and drainage.. 4. MATERIAL & METHODS

Sample size- All cases admitted between period June 2011 June 2013 Number of cases - 25

Type of study- Prospective Duration of study:- 2 years

5. DETAILED RESEARCH PLAN (Groups / Procedures etc) Patients will be selected according to the selection criterion i.e - All patients belonging to all age groups having hand infections will be included in the study. Selected patients will be evaluated by - Proper history - clinical examination - Investigations

Plan of the studyAll patients coming to the casualty and outdoor patient department with non specific complaints associated with hand infections such as pain, swelling, redness, pus and discharge will be evaluated. One important aspect of this study will be follow up of these patients. Various conditions that will be considered in this study are: 1) Paronychia 2) Herpetic whitlow 3) Felon 4) Tenosynovitis 5) Secondary infections of post traumatic crush injuries. 6) Cellulitis 7) Infections of the joint spaces, web spaces and palmar spaces The aim of this study will be early diagnosis and treatment of hand infections. This is important as more often than not hand infections

go undiagnosed and are associated with significant morbidity and devastating complications such as stiffness, contractures and amputation. One important life threatening condition is necrotizing fasciitis which because of its spreading nature requires early diagnosis and early surgical management. A detailed understanding of the anatomy of the hand is essential for the appropriate surgical management of hand infections. This includes the following: 1) bones and joints 2) skin 3) palmar spaces 4) muscles and tendons One of the most common causes of hand infections is penetrating trauma which introduces various organisms most common ones being staphylococci and streptococci. In immunocompromised conditions and diabetes mellitus gram negative and anaerobic organisms have also been implicated. Patients will be evaluated under the following criteria: 1) history 2) clinical findings- local and systemic findings 3) laboratory investigations blood culture, blood sugar levels, blood counts 4) gram staining, anaerobic cultures to identify the causative organisms. 5) Radiological investigations such as x-rays to rule out involvement of bones and joints and to exclude fractures and foreign body.

Management: Goal of treatment of hand infections is rapid and full recovery of function as well as prevention of complications Management includes: 1) Conservative management 2) Active surgical mangement Conservative line of management is usually adopted in the early stages of the disease when the infection has been diagnosed 24-48 hours after the onset. It includes: 1) Splinting 2) Elevation of limb 3) Moist heat to the affected part 4) Systemic antibiotics oral or intravenous Following conservative treatment, follow up of the patient will be done. Decrease in presenting symptoms will be indicative of effectiveness of conservative treatment while increase in symptoms and local skin changes(increased swelling, redness, tenderness, pus discharge)will be indicative of failure of conservative treatment thus compelling the need for active surgical treatment. Surgical treatment is considered when conservative means fail to control the infection. 1) Open drainage 2) Debridement Thus in conclusion, my study aims at treating hand infections at an early stage so that the optimal function of the hand can be preserved. Complications include septicemia, gangrene, contractures, amputation of the involved limb.

6.

SELECTION OF CASES (Inclusion & Exclusion Criteria)

Case selection (Inclusion criterion) All patients having hand infections.

7. CASE RECOD FORMS :1. Name 2. Age 3. Sex 4. Address 5. Occupation 6. Religion 7. Chief complaints 8. History 9. Past history 10.Any trauma related history 11.Any other relevant past surgical procedure performed

General examination Temperature Pulse Respiration Blood pressure

Respiratory rate Weight Pallor\ icterus\ cyanosis\clubbing Lynphadenopathy \edema C.V S examination Respiratory system examination C.N S examination Examination for cervical spine and thoracic outlet syndrome Examination of distal circulation(radial and ulnar pulsation) 9. PARAMETERS : Routine lab Investigations Hb BT/CT Urine examination Blood sugar Renal profile Liver profile HIV and HbSAg testing

Radiological investigations - X-ray - Ultrasound - MRI

10

FACILITIES AVAILABLE: O.T for surgery

Basic surgical instruments

12. REQUIREMENTS : O.T for surgery Basic surgical instruments

13.REFERENCES :
1. Hausman MR, Lisser SP. Hand infections. Orthop Clin North Am. 1992;23:17185. 2. Nathan R, Taras JS. Common infections in the hand. In: Hunter JM, Mackin E, Callahan AD, eds. Rehabilitation of
the hand: surgery and therapy. 4th ed. St. Louis: Mosby, 1995:25160. 3. Moran GJ, Talan DA. Hand infections. Emerg Med Clin North Am. 1993;11:60119. 4. Brown DM, Young VL. Hand infections. South Med J. 1993;86:5666. 5. Krieger LE, Schnall SB, Holtom PD, Costigan W. Acute gonococcal flexor tenosynovitis. Orthopedics. 1997;20:64950. 6. Schaefer RA, Enzenauer RJ, Pruitt A, Corpe RS. Acute gonococcal flexor tenosynovitis in an adolescent male with pharyngitis. A case report and literature review. Clin Orthop. 1992;281:2125. 7. Townsend DJ, Singer DI, Doyle JR. Candida tenosynovitis in an AIDS patient: a case report. J Hand Surg [Am]. 1994;19:2934. 8. Gunther SF, Gunther SB. Diabetic hand infections. Hand Clin. 1998;14:64756. 9. Bhatty MA, Turner DP, Chamberlain ST. Mycobacterium marinum hand infection: case reports and review of literature. Br J Plast Surg. 2000;53:1615. 10. Gomperts BN, White LK. Gonococcal hand abscess. Pediatr Infect Dis J. 2000;19:6712. 11. Rockwell PG. Acute and chronic paronychia. Am Fam Physician. 2001;63:11136. 12. Jebson PJ. Infections of the fingertip. Paronychias and felons. Hand Clin. 1998;14:54755. 13. Roberge RJ, Weinstein D, Thimons MM. Perionychial infections associated with sculptured nails. Am J Emerg Med. 1999;17:5812. 14. Harrison BP, Hilliard MW. Emergency department evaluation and treatment of hand injuries. Emerg Med Clin North Am. 1999;17:793822. 15. Stern PJ. Selected acute infections. Instr Course Lect. 1990;39:53946. 16. Watson PA, Jebson PJ. The natural history of the neglected felon. Iowa Orthop J. 1996;16:1646.

17. Connolly B, Johnstone F, Gerlinger T, Puttler E. Methicillin-resistant Staphylococcus aureus in a finger

felon. J Hand Surg. 2000;25:1735. 18. Karanas YL, Bogdan MA, Chang J. Community acquired methicillin-resistant Staphylococcus aureus hand infections: case reports and clinical implications. J Hand Surg. 2000;25:7603. 19. Mohler A. Herpetic whitlow of the toe. J Am Board Fam Pract. 2000;13:2135. 20. Crumpacker CS. Herpes simplex. In: Freedberg IM, Fitzpatrick TB, eds. Fitzpatrick s Dermatology in general medicine. 5th ed. New York: McGraw-Hill, 1999:241426. 21. Schwandt NW, Mjos DP, Lubow RM. Acyclovir and the treatment of herpetic whitlow. Oral Surg Oral Med Oral Pathol. 1987;64:2558. 22. Gill MJ, Arlette J, Buchan K, Tyrrell DL. Therapy for recurrent herpetic whitlow. Ann Intern Med. 1986;105:631. 23. Laskin OL. Acyclovir and suppression of frequently recurring herpetic whitlow. Ann Intern Med. 1985;102:494 5. 24. Boles SD, Schmidt CC. Pyogenic flexor tenosynovitis. Hand Clin. 1998;14:56778. 25. Kanavel AB. Infections of the hand. Aguide to the surgical treatment of acute and chronic suppurative processes in the fingers, hand, and forearm.7th ed. Philadelphia: Lea & Febiger, 1939. 26. Neviaser RJ. Tenosynovitis. Hand Clin. 1989;5:52531. 27. Schnall SB, Vu-Rose T, Holtom PD, Doyle B, Stevanovic M. Tissue pressures in pyogenic flexor tenosynovitis of the finger: compartment syndrome and its management. J Bone Joint Surg [Br]. 1996;78:7935. 28. Cardinal E, Bureau NJ, Aubin B, Chhem RK. Role of ultrasound in musculoskeletal infections. Radiol Clin North Am. 2001;39:191201. 29. Lille S, Hayakawa T, Neumeister MW, Brown RE, Zook EG, Murray K. Continuous postoperative catheter irrigation is not necessary for the treatment of suppurative flexor tenosynovitis. J Hand Surg. 2000;25B:3047. 30. Griego RD, Rosen T, Orengo IF, Wolf JE. Dog, cat, and human bites: a review. J Am Acad Dermatol. 1995;33:101929. 31. Kelleher AT, Gordon SM. Management of bite wounds and infection in primary care. Cleve Clin J Med. 1997;64:13741. 32. Perron AD, Miller MD, Brady W J. Orthopedic pitfalls in the ED: fight bite. Am J Emerg Med. 2002;20:1147. 33. Patzakis MJ, Wilkins J, Bassett RL. Surgical findings in clenched-fist injuries. Clin Orthop. 1987;220:23740. 34. Dellinger EP, Wertz MJ, Miller SD, Coyle MB. Hand infections. Bacteriology and treatment: a prospective study. Arch Surg. 1988;123:74550. 35. Zubowicz VN, Gravier M. Management of early human bites of the hand: a prospective randomized study. Plast Reconstr Surg. 1991;88:1114. 36. Medeiros I, Saconato H. Antibiotic prophylaxis for mammalian bites (Cochrane Review). Cochrane Database Syst Rev. 2003;2:CD001738. 37. Louis DS, Jebson PJ. Mimickers of hand infections. Hand Clin. 1998;14:51929. 38. Matsui T. Acute nonspecific flexor tenosynovitis in the digits. J Orthop Sci. 2001;6:2347.

NAME AND SIGNATURE OF POSTGRADUATE STUDENT (DR MISHRA AJIT MATAPRASAD):

NAME AND SIGNATURE OF POSTGRADUATE GUIDE

(DR SHAILAJA P JADHAV):

PROFESSOR AND HEAD, DEPARTMENT OF SURGERY B. J. MEDICAL COLLEGE, PUNE.

Appendix 3:

INFORMED CONSENT FORM

For submission of Research proposal to Ethics Committee of B.J.M.C. and S.G.H. Pune
1. I, Mr./ Mrs. ____________________________________, age ______ years residing at _________________________________________________________________ hereby give my informed consent to participate in COMPLICATION AND MANAGEMENT OF HAND INFECTIONS project.. 2. There is no compulsion on me to participate in this project and I am giving my free consent for it. 3. I am ready and willing to undergo all tests and treatments in the present project.

4. I have read and I have been explained the general information and purpose of the present project.

5. I have been informed / I have read the probable complications while participating in the present project. 6. I know that I can withdraw from the present project at any time.

7. Any data or analysis of this project will be purely used for scientific purpose and my name will be kept confidential except when required for any legal purpose. 8. I can read English / I can understand data read out to me in English.

Signature 0f Volunteer Signature of parent/Guardian in case Of minor person.

Witnesses: 1. 2. Signature of Principal Investigator.

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APPENDIX 5:
UNDERTAKING BY THE INVESTIGATOR
For submission of Research proposal to Ethics Committee of B.J.M.C. and S.G.H. Pune
1] Full name, address and title of the Principal Investigator Dr. SHAILAJA P JADHAV
PROFESSOR DEPT OF SURGERY

B.J.MEDICAL COLLEGE, PUNE

2]

Name and address of the medical college, hospital or other facility where the clinical trial will be conducted: Education, training & experience that qualify the Investigator for he clinical trial (Attach details including Medical Council registration number, and /or any other statement(s) of

qualification(s) Dr. MISHRA AJIT MATAPRASAD

RESIDENT DEPT OF SURGERY B.J.MEDICAL COLLEGE, PUNE.

3] 4]

Name and address of all clinical laboratory facilities to be used in the study. Name and address of the Ethics Committee that is responsible for approval and continuing review of the study. B.J.M.C. SGH, Pune

5]

Names of the other members of the research team (Co-or subInvestigators) who will be assisting the Investigator in the conduct of the investigation(s).

6]

Protocol Title and study number (if any) of the clinical trial to be conducted by the Investigator.

7]

Commitments i. I have reviewed the clinical protocol and agree that it contains all the necessary information to conduct the study. I will not begin the study until all necessary Ethics Committee and regulatory approvals have been obtained. ii. I agree to conduct the study in accordance with the current protocol. I will not implement any deviation from or changes of the protocol without agreement by the Sponsor and prior review and documented approval/favorable opinion from the Ethics Committee of the amendment, except where necessary to eliminate an immediate hazard(s) to the trial Subjects or when the change(s) involved are only logistical or administrative in nature. iii. I agree to personally conduct and/or supervise the clinical trial at my site.

iv.

I agree to inform all Subjects that the drugs are being used for investigational purposes and I will ensure that the requirements relating to obtaining informed consent and ethics committee review and approval specified in the GCP guidelines are met.

v.

I agree to report to the Sponsor all adverse experiences that occur in the course of the investigation(s) in accordance with the regulatory and GCP guidelines.

vi.

I have read and understood the information in the Investigators broacher, including the potential risks and side effects of the drug.

vii.

I agree to ensure that all associates, colleagues and employees assisting in the conduct of the study are suitably qualified and experienced and they have been informed about their obligations in meeting their commitments in the trial.

viii.

I agree to maintain adequate and accurate records and to make those records available for audit/inspection by the Sponsor, Ethics Committee, Licensing Authority or their authorized representatives, in accordance with regulatory and GCP provisions; I will fully cooperate with any study related audit conducted by regulatory officials or authorized representatives of the Sponsor.

ix.

I agree to promptly report to the Ethics Committee all changes in the clinical trial activities and all unanticipated problems involving risks to human subjects or others.

x.

I agree to inform all unexpected serious adverse events to the Sponsor as well as the Ethics Committee within seven days of their occurrence.

xi.

I will maintain confidentiality of the identification of all participating study patients and assure security and confidentiality of study data.

xii.

I agree to comply with all other requirements, guidelines and statutory obligations as applicable to clinical investigators

participating in clinical trails. 8] Signature of Investigators with Name and Date. Name Signature Date

Investigators

Principal Investigator

Co-Investigator 1

Co-Investigator 2

Appendix 6: CERTIFICATE from HOD

For submission of Research proposal to Ethics Committee of B.J.M.C. and S.G.H. Pune
Date: This is to certify that Research Protocol entitled

COMPLICATION AND MANAGEMENT OF HAND INFECTIONS

Has been presented, discussed and modified accordingly. Further it is stated that to the best of my knowledge there is no ethical dispute in this research protocol and therefore may be approved by the Ethics Committee, B. J. Medical College & Sassoon General Hospitals, and Pune.

Signature