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BANGALORE – KARNATAKA PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION GIJOSE. T. M 1 year M.Sc (Nursing) MASTER IN MEDICAL-SURGICAL NURSING YEAR 2009-2010 St CAUVERY COLLEGE OF NURSING # 42/2B, 2C, TERESIAN CIRCLE SIDDARTHA LAYOUT MYSORE. RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA. PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION 1.0 NAME OF THE CANDIDATE AND ADDRESS GIJOSE. T. M 1st YEAR M.SC NURSING, CAUVERY COLLEGE OF NURSING, MYSORE. 2.0 NAME OF THE INSTITUTION CAUVERY COLLEGE OF NURSING, MYSORE. 3.0 COURSE OF THE STUDY AND SUBJECT MASTER IN NURSING, MEDICAL SURGIAL NURSING 4.0 DATE OF ADMISSION TO COURSE 15. 06. 2009 5.0 TITLE OF THE STUDY A STUDY ON HONEY DRESSING FOR DIABETIC FOOT ULCER HEALING 5.1 STATEMENT OF THE PROBLEM A STUDY TO DETERMINE THE EFFECTIVENESS OF HONEY DRESSING FOR DIABETIC FOOT ULCER HEALING AMONG PATIENTS WITH TYPE II DIABETES MELLITUS IN SELECTED HOSPITAL SETTINGS AT MYSORE. 6. BRIEF RESUME OF THE INTENDED WORK: 6.1 INTRODUCTION Diabetes mellitus is recognized to be common in Indians of Asian subcontinent. In 2005, Vijay Viswanathan, Sharad Pendsey and Arun Bal reported that currently 25 million Indians have diabetes. The projections indicate that India will have the largest number of diabetic patients by the year 2025 A.D. The loss of a limb or foot is one of the most feared complications of diabetes and yet foot problems remain the commonest reason for diabetic patients to be hospitalized.1 Bloomgarden ZT in 2004 reported that more than seventy percent diabetics develop foot ulcers in their lifetime Foot infections spread very quickly without giving much warning. Minor injuries become ulcerated leading to deep seated abscess and cellulites. Bone involvement is also very fast. Sore swelling local warmth redness with or without fever may be the consequences of a mild to moderate injury.2 Dr Basab Ghosh in 2009 reported Diabetic foot ulcers are common and estimated to affect 15% of all diabetic individuals during their lifetime. Diabetic foot ulcers precede almost 85% of amputations. There are two main reasons for the foot complication. Some diabetic patients develop a diabetic peripheral neuropathy characterized by loss of sensation in the feet. Such patients have a high risk of injuries which often go unnoticed. Diabetic patients particularly those with neuropathy have abnormal pressure points under the feet. In these area, the skin gets thickened (called callus) which then becomes an ulcer. Chronic infection in the ulcer ultimately leads to amputation of a toe or the whole foot. These two groups of patients are considered to have “High Risk Feet”3 Lipsky in 2004 reported the Treatment of diabetic foot ulcer includes debridement with removal of all necrotic tissue and oral antibiotics (emergency referral) with removal of necrotic or poorly vascular zed tissue, including infected bone.- Revascularization if necessary. Metabolic control and treatment of co morbidity -Optimal diabetes control, if necessary with insulin The ulcer care includes- Frequent wound debridement, Frequent wound inspection and absorbent, non-adhesive, non-occlusive dressings. In 2008 the natural remedies e mail article reported that the current trends in the community dermatology focusing the ulcer healing by the simple natural remedies which includes topical application of banana leaf, bee propolis, myrrh and honey dressings.5 6.2 NEED FOR THE STUDY Devender Singh in 2006 reported that “India is the diabetic capital of the world” with its largest share of diabetic persons. Among persons with diabetes about 15% will experience a foot ulcer in their lifetime, and about 14-24% of them will require an amputation. In the US, an annual incidence of 2% to 3% and a prevalence of 4% to 10% have been reported. These figures indicate that a large percentage of foot ulcers are chronic. 6 Wild S et al in 2004 informed that, The number of people with diabetes worldwide was estimated at 131 million in 2000 ; it ulcers is ~ 3%, and the reported incidence in U.S. and U.K. studies ranges as high as 10% is projected to increase to 366 million by 2030.7 Singh N, Armstrong DG, Lipsky BA studies in 2005 has indicated that diabetic patients have up to a 25% lifetime risk of developing a foot ulcer. 8 Reiber GE, Vileikyte L, Boyko EJ, in 1999 have reported once an ulcer has developed, there is an increased risk of wound progression that may ultimately lead to amputation; diabetic ulceration has been shown to precede amputation in up to 85% of cases. 9At least 40% of amputations in diabetic patients can be prevented with a team approach to wound care.9 Devender Singh in 2006 reported that needing a first amputation is a poor prognostic sign in diabetic patients; 28% to 51% of these patients require a second amputation with 5 years. The 5-year mortality rate after lower extremity amputation ranges from 39% to 68%. The vast majority of diabetic foot complication resulting in amputation begins with the formation of skin ulcer 6 Bridges RM, Deitch EA reported in 1994 conducted routine annual foot screening facilitates early interventions to reduce the incidence of the most common precipitating events including injury and foot-related trauma to the insensitive foot.9 The key elements of preventive care include: annual examination of the feet by healthcare providers to determine risk factors for ulceration, subsequent examination of high risk foot ulcer and dressings of foot ulcer. The selection of wound dressings is also an important component of diabetic wound care management. There are a number of available dressing types to consider in the course of wound care. The easy and simple natural dressings is the honey dressings.10 Cooper RA, Molan PC in 1999 reported that the topical application of honey on wound act as a deodorant, an effect attributed to the presence of glucose, which is metabolized by bacteria in preference to proteinaceous necrotic tissue, resulting in the production of lactic acid and not the malodorous compounds generated by protein degradation. In addition, the observed benefits of honey in infected wounds may be attributed to the high glucose content and low pH, both of which stimulate macrophages.11 Honey is an inexpensive moist dressing with antibacterial and tissuehealing properties that has shown promise in the medical literature. It can be very effective in diabetic foot ulcer healing.11 Wisconsin school of medicine ,USA Eddy JJ, Gideonsen MD, Mack GP in 2008, used the topical honey and are currently conducting a randomized controlled trial of its effectiveness in treating diabetic foot ulcers. In this review, the authors summarize evidence of honey's effectiveness, its hypothesized mechanism of action, potential risks and benefits, the types of honey available, and the nature of its application. Critical aspects of ulcer care are also reviewed. The study concluded that honey is a low-cost topical therapy with important potential for healing. 12 From the above reviews and with investigator’s clinical experience, the wound dressing with honey dressings given various benefits in different types of wound. So the investigator plans to conduct the study to evaluate the effectiveness of honey dressings on diabetic foot ulcer healing. 6.3 STATEMENT OF THE PROBLEM A study to determine the effectiveness of honey dressing for diabetic foot ulcer healing among the patients with type II Diabetes mellitus in selected hospital settings at Mysore. 6.4 OBJECTIVES 1. To assess the pre test level of ulcer healing in both experimental and control group. 2. To evaluate the effectiveness of honey dressing by comparing the pretest and post test scores in both experimental and control group. 3. To associate the post test level of ulcer healing with selected socio 4. demographic variables in both experimental and control group such as 5. age, sex, duration of illness, foot ulcer duration, blood glucose level and 6. type of treatment. 6.5 HYPOTHESES H1. There is a significant increase in the level of diabetic ulcer healing in experimental group than in control group. H2. There is a significant association between experimental group and control group with demographic variables such as age, sex, duration of illness, foot ulcer duration, blood glucose level and type of treatment. 6.6. OPERATIONAL DEFINITIONS: 1. EVALUTE: Measure the level of healing of foot ulcer before and after the intervention. 2. EFFECTIVENESS: Outcome of the intervention measured in terms of stages of wound healing. 3. HONEY DRESSINGS: Topical application of natural honey on diabetic foot ulcer. 4. DIABETIC FOOT ULCER: One of the complication of diabetes mellitus in the foot, due to the pressure exerted on foot leads to neuropathy and vasculopathy causes wound or ulcer. . 6.7. ASSUMPTION: a. Natural remedies can be easily availed by the person. b. Honey dressing promotes wound healing. c. Honey has effect to heal chronic wounds. d. Honey is stimulating macrophages activity. e. Honey available in the low cost 6.8. DELIMITATION: 1. The sample size is limited to 60 patients 2. Prescribed data collection period is only 4 to 6 wks. 6.9. CONCEPTUAL FRAME WORK: The Ludwig Open system model will be adopted as a conceptual framework for this study. The Components are input, throughput and output. The input describes the sample characteristics and existing health condition. Through put describes the intervention. The output refers to the outcome of the intervention. 6.10. REVIEW OF LITERATURE: The review of literature is defined as a broad, comprehensive in depth, systematic and critical review of scholarly publications, unpublished scholarly print materials, audio visual materials and personal communications. The review of literature will be discussed based on the following headings 1. Studies related to diabetic foot ulcer. 2. Studies related to honey dressings and wound healing. 1. Studies related to diabetic foot ulcer According to the Marcus M. Riedhammer, M.D geisinger medical center reported in 2009 that “Foot ulcers can be painful and can lead to further infections and even limb amputation if they are not monitored or treated correctly.” Diabetes can cause nerve damage, which lessens a diabetic’s ability to feel when an injury develops, and it can adversely affect circulation and the body’s ability to help wounds heal or fight off infection. “Because of these issues, diabetics are particularly susceptible to developing foot ulcers,” suggested checking and washing feet daily and wearing shoes that fit correctly to avoid developing these ulcers. Rest and limiting pressure to the ulcer is very important, apart from taking prescribed antibiotics in the case of an infection. The workshop concluded: “Foot ulcers may seem like a minor issue, but they can pose a serious threat to your health. By checking your feet every day, being aware of the risks.13 In the pharma express, Amrita Diabetic Foot Conference 2009 reported that 40.9 million diabetic patients and 81.8 million feet to be taken care of, India is a country where 40,000 lower extremity amputations occur per year. According to experts, even though this is still a grossly underestimated figure, the horrifying figures recommend an urgent reality check not just on the part of awareness about the newer treatments modalities in the area of diabetic foot management for the Indian doctors but also an increased awareness among the masses. Ulcers pose and consulting a doctor upon the first sign of a wound developing, the risks and side effects of foot ulcers can be minimized. The three-day conference dealt with a various issues pertaining to diabetic foot management, including the newer therapies, drugs and put a new light on the overall management of the diabetic foot.14 In 2006 the collective experience of treating patients with neuropathic diabetic foot ulcers in four major diabetic foot programs in the United States and Europe was analyzed by Brem H, Sheehan P and Rosenberg H J et al. Results shows that the following protocol was developed for patients with diabetic foot ulcers: (1) establishment of good communication among the patient, the wound healing team, and the primary medical doctor; (2) comprehensive, protocoldriven care of the entire patient, including hemoglobin A1c, microalbuminuria, and cholesterol as well as early treatment of retinopathy, nephropathy, and cardiac disease; (3) weekly objective measurement of the wound with digital photography, planimetry, and documentation of the wound-healing process using the Wound Electronic Medical Record, if available; (4) objective evaluation of blood flow in the lower extremities (e.g., noninvasive flow studies); (5) debridement of hyperkeratotic, infected, and nonviable tissue; (6) use of systemic antibiotics for deep infection, drainage, and cellulitis; (7) off-loading; (8) maintenance of a moist wound bed; (9) use of growth factor and/or cellular therapy if the wound is not healing after 3 weeks with this protocol; and (10) consideration of the use of vacuum-assisted therapy in complex wounds. The study concluded that in diabetic foot ulcers, availability of the above modalities, in combination with early recognition and comprehensive treatment, ensures rapid healing, minimizes morbidity and mortality rates, and eliminates toe and limb amputations in the absence of ischemia and osteomyelitis.15 2. Studies related to honey dressings and wound healing Shukrimi A in 2008, conducted a prospective study to compare the effect of honey dressing for Wagner's grade-II diabetic foot ulcers with controlled dressing group (povidone iodine followed by normal saline). Surgical debridement and appropriate antibiotics were prescribed in all patients. There were 30 patients age between 31 to 65-years-old (mean of 52.1 years). The mean healing time in the standard dressing group was 15.4 days (range 9-36 days) compared to 14.4 days (range 7-26 days) in the honey group (p < 0.005). In conclusion, ulcer healing was not significantly different in both study groups. Honey dressing is a safe alternative dressing for Wagner grade-II diabetic foot ulcers.16 In Italy ,the study conducted byBeretta G, Artali R, Caneva E,et al in2009, wound-healing properties of honey are well established and it has been suggested that, among its pharmaco-active constituents, kynurenic acid (KA) exerts antinociceptive action on injured tissue by antagonizing NMDA at peripheral GABA receptors. The aim of this study was to investigate the quantitative profile of kynurenic acid and of two recently identified, structurally related derivatives, 3-pyrrolidinyl-kynurenic acid (3-PKA) and its gamma-lactamic derivative (gamma-LACT-3-PKA), by examining their mass spectrometric behavior, in honeys from different botanical sources. Small amounts of kynurenic acid were found in honeydew, sunflower, multifloral, almond and eucalyptus honeys, in the range of 23.1-143 mg/kg, suggesting contamination with chestnut honey. Total phenol content (TPC) was in the range from 194.9 to 1636.3 mg(GAE)/kg and total antiradical activity (TAA) from 61 to 940 mg/(GAE)/kg), depending on the botanical origin. Principal component analysis (PCA) was then done on these data. The three different clusters depicted: (i) antinociceptive activity from kynurenic acid and/or its derivatives, typical of chestnut honey; (ii) antioxidant/radical scavenging activity by antioxidants responsible for the antiinflammatory action (dark honeys); (iii) peroxide-dependent antibacterial activity due to H (2)O(2) production by glucose oxidase in honey. The Principle component analysis findings provide useful indications for the dermatologist for the treatment of topical diseases, and the profiling of kynurenic acid and its derivatives may shed light on new aspects of the kynurenine pathway involved in tryptophan metabolism.17 The study conducted by Stephen-Haynes J in 2004 on Honey has been used for its healing properties for centuries and has been used to dress wounds with favorable results. The emergence of antibiotic resistance and growing interest in "natural" or "complementary" therapies has led to an interest in honey dressings. Much of the research to date has been related to honey's antibacterial properties. However, the healing properties claimed for honey also include stimulating new tissue growth, moist wound healing, fluid handling and promoting epithelialization. Until recently, honey had not been developed as a wound management product and was not a certified pharmaceutical device. Activon Tulle is a sterile, non-adherent dressing impregnated with Leptospermum scoparium hone. The claimed properties of honey dressings would make this a valuable addition to the dressing currently available in the primary care setting. An evaluation was undertaken involving 20 patients with a variety of wounds. A conclusion is drawn that while further research is needed, medical grade honey does appear to be a valuable addition to the wound management formulary. 18 The study conducted on by.Lay-flurrie K in 2008 use of honey in wound management. This is largely due to the growing clinical problem of antibioticresistant bacteria and the combined difficulties for the practitioner in managing chronic wound types, such as burns, leg ulcers or surgical wounds, which may become infected, for example, with methicillin-resistant Staphylococcus aureus or Pseudomonas. The associated costs of treating such wounds are escalating as a result. While the use of honey as a wound dressing has been recognized, at least since Egyptian times circa 2000 BC, it is only more recently, due to the development and licensing of modern honey wound dressings, that such dressings have become more widely available and used in wound management. This article focuses on the use of honey in the treatment of infected wounds and burns. It will examine the effects of honey at the wound bed and its clinical applications, along with the current dressings available. Also discussed are the practical considerations, if, like any wound dressing, honey is to be used safely, appropriately and for the benefit of the patient.19 Jull AB, Rodgers A and Walker N in 2008, New Zealand the evidence based study conducted by to determine whether honey increases the rate of healing in acute wounds (burns, lacerations and other traumatic wounds) and chronic wounds (venous ulcers, arterial ulcers, diabetic ulcers, pressure ulcers, infected surgical wounds). We searched the Cochrane Wounds Group Specialised Register (May 2008), CENTRAL (May 2008) and several other electronic databases (May 2008). Bibliographies were searched and manufacturers of dressing products were contacted for unpublished trials. Randomised and quasi randomised trials that evaluated honey as a treatment for any sort of acute or chronic wound were sought. There was no restriction in terms of source, date of publication or language. Wound healing was the primary endpoint. Data from eligible trials were extracted and summarized using a data extraction sheet by one author and independently verified by a second author. The results shows that 19 trials (n=2554) were identified that met the inclusion criteria. In acute wounds, three trials evaluated the effect of honey in acute lacerations, abrasions or minor surgical wounds and nine trials evaluated the effect the honey in burns. In chronic wounds two trials evaluated the effect of honey in venous leg ulcers and one trial in pressure ulcers, infected postoperative wounds, and Fournier's gangrene respectively. Two trials recruited people with mixed groups of chronic or acute wounds. The poor quality of most of the trial reports means the results should be interpreted with caution, except in venous leg ulcers. In acute wounds, honey may reduce time to healing compared with some conventional dressings in partial thickness burns (WMD -4.68 days, 95%CI -4.28 to -5.09 days). All the included burns trials have originated from a single centre, which may have impact on replicability. In chronic wounds, honey in addition to compression bandaging does not significantly increase healing in venous leg ulcers (RR 1.15, 95%CI 0.96 to 1.38). There is insufficient evidence to determine the effect of honey compared with other treatments for burns or in other acute or chronic wound types. Honey may improve healing times in mild to moderate superficial and partial thickness burns compared with some conventional dressings. Honey dressings as an adjuvant to compression do not significantly increase leg ulcer healing at 12 weeks. There is insufficient evidence to guide clinical practice in other areas.20 In 2008 Guildford Surrey, UK. the study conducted by Visavadia BG, Honeysett J, and Danford MH an Manuka honey dressing: An effective treatment for chronic wound infections.The battle against methicillin-resistant Staphylococcus aureus (MRSA) wound infection is becoming more difficult as drug resistance is widespread and the incidence of MRSA in the community increases. Manuka honey dressing has long been available as a non-antibiotic treatment in the management of chronic wound infections. We have been using honey-impregnated dressings successfully in our wound care clinic and on the maxillofacial ward for over a year.21 7. MATERIALS AND METHODS OF STUDY 7.1. SIGNIFICANCE OF STUDY The purpose of the study is to assess the effectiveness of honey dressing for diabetic foot ulcer healing among patients with type II diabetes mellitus. 7.2. SOURCE OF DATA Patients those who are admitted in the selected Hospitals at Mysore 7.3. RESEARCH DESIGN The research design adopted for the study was quasi experimental (two group pre test and post test design) with manipulation, control group and randomization Experimental group Control group O1 X O2 O1 ------ O2 O1 - Pretest level of ulcer. O2 - Posttest level of ulcer. X - Intervention-honey dressings. 7.4. METHOD OF DATA COLLECTION Observation checklist for assessing stages of wound healing. 7.5. SAMPLING PROCEDURE 7.5.1. SAMPLING CRITERIA Inclusion criteria 1. The patient with type II diabetes mellitus and having diabetic foot ulcer 2. Patients who are admitted in medical wards 3. Those who are willing to participate in the study Exclusion criteria 1. Those who have type I diabetes mellitus 2. Patient with severe gangrenous foot ulcer 3. Patient with diabetic coma and diabetic keto- acidosis 7.5.2. POPULATION Patients who are admitted in selected hospital settings at Mysore. 7.5.3 SAMPLES Patients those who are fulfilling the sampling criteria. 7.5.4. SAMPLE SIZE Sample comprises of 60 patients .Thirty for experimental group and thirty for control group. 7.5.5. SAMPLING TECHNIQUE Non Probability – Purposive sampling. 7.5.6. SETTING The study will be conducted in Government Hospital, Mysore. 7.5.7. PILOT STUDY Pilot study is planned with the 10% of sample size. 7.6. VARIABLES Independent variable Honey dressing is an independent variable. Dependent variables Diabetic foot ulcer healing is a dependent variable. 7.7. PLAN FOR DATA ANALYSIS The data analysis will be done by descriptive statistics and inferential statistics. The descriptive statistics are the percentage, mean, and standard deviation and inferential statistics are independent‘t’ test and chi square test. 7.8. PROJECTED OUTCOME: The findings of the study would reveal: 1. The existing level ulcer healing in the diabetic foot 2. The effectiveness of honey dressing in promoting the diabetic foot ulcer healing foot. 3. The study will motivate the health personnel to use natural remedies in wound care. 7.9. ETHICAL CONSIDERATION: Has ethical clearances been obtained from institution or concerned authority? Yes. Whether the ethical committee’s suggestions and opinions will be taken into consideration? Yes. 8. LIST OF REFERENCE: 1. Vijay Viswanathan, Sharad Pendsey, Arun Bal. Diabetic Foot in India Diabetic Foot in India Medicine Update 2005. 2. Bloomgarden ZT. Diabetes complications. Diabetes Care 2004;27: 1506–14. 3. Dr Basab Ghosh , MBBS, MDRC (Chennai), Dip Diab. Consultant Diabetologist, Dr Basab‘S Diabetes Care, Old Kalibari Road, Krishnanagar, Agartala, Tripura, India. www.google.com 2009. 4. Lipsky BA Medical treatment of diabetic foot infections. Clin Infect Dis 39:S104- S114, 2004 . 5. www.natural/ remedies.com /cached pages updated 2008 6. Devender Singh et al.Diabetic foot: It’s time to share the burden Calicut Medical Journal 2006;4(3):e4 7. Wild S, Roglic G, Green A, Sicree R, King H : Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 2004 27:10471053, 8. Singh N, Armstrong DG, Lipsky BA : Preventing foot ulcers in patients with diabetes. JAMA,2005 293:217-228, 9. Reiber GE, Vileikyte L, Boyko EJ, : Causal pathways for incident lower extremity ulcers in patients with diabetes from two settings. Diabetes Care 22:157-162, 1999 10. Bridges RM, Deitch EA . Diabetic foot infections: pathophysiology and treatment. Surg Clin North Am ,1994 74:537-555, 11. Cooper RA, Molan PC. Honey in wound care. Journal Wound Care 1999; 8: 340. 12. Eddy JJ, Gideonsen MD, Mack GP..Practical considerations of using topical for neuropathic diabetic foot ulcers: a review. Wisconsin Medical 2008 Jul;107(4):187-90 13. Marcus M. Riedhammer, M.D .Foot ulcers dangerous for diabetics foot by ANI on November 26, 2009 14. Amrita Diabetic Foot Conference 2009'Lack of Awareness about Diabetic Foot Lead to Delay in Treatment'www.expresshealthcare.in july 2009 15. Brem H, Sheehan P, and Rosenberg HJ et al.Evidence-based protocol for diabetic foot ulcers. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):193S-209S; discussion 210S-211S. 16. Shukrimi A, Sulaiman AR, Halim AY and Azril A.A comparative study between honey and povidone iodine as dressing solution for Wagner type II diabetic ulcers. Med J Malaysia. 2008 Mar;63(1):44-6. 17. Beretta G, Artali R, Caneva Eet al.Quinoline alkaloids in honey: analytical (HPLC-DAD-ESIMS, multidimensional diffusion-ordered pectroscopy), theoretical and chemometric studies. J Pharm Biomed Anal. Oct15;50(3):432-9. Epub 2009 Jun 6. 18. Stephen-Haynes J.Evaluation of a honey-impregnated tulle dressing in primary care. Br J Community Nurs. 2004 Jun;Suppl:S21-7. 19. Lay-flurrie KHoney in wound care: effects, clinical application and patient benefit. British Journal of Nursing. 2008 Jun12-25;17(11):S30, S32-6. 20. Jull AB, Rodgers A, Walker N.Honey as a topical treatment for wounds. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD005083. 21.Visavadia BG, Honeysett J, Danford MH.Manuka honey dressing: An effective treatment for chronic wound infections. Br J Oral Maxillofac Surg. 2008 Jan;46(1):55-6. Epub 2006 Nov 20. 9. SIGNATURE OF THE CANDIDATE 10. REMARKS OF THE GUIDE RECOMMENDED AND FORWARDED 11. NAME AND DESIGNATION OF (IN BLOCK LETTERS) 11.1 GUIDE 11.2 SIGNATURE 11.3 CO-GUIDE (IF ANY) 11.4 SIGNATURE 11.5 HEAD OF THE DEPARTMENT 11.6 SIGNATURE 12.1 REMARKS OF THE CHAIRMAN AND PRINCIPAL 12.2 SIGNATURE RECOMMENDED AND FORWARDED