Sam Proposal
Sam Proposal
TITLE:
“A Research Proposal Submitted in Partial Fulfillment for the requirements for the
award of Diploma in Medical Laboratory Sciences in the Department of Health
Science, Kisii National Polytechnic.
FEBRUARY, 2023
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DECLARATION
I declare that;
This proposal is my original work and has not been presented for a diploma or any award in any
other university or institution of higher learning.
Signature................................................. Date..........................................
Samwel Omondi Otieno
Reg. no.UDMLTJ22/013.
Declaration by supervisor
This proposal has been submitted for examination with our approval as university supervisors
Signature................................................. Date..........................................
Vincent Orucho.
Lecturer Department of Health Sciences
Kisii National Polytechnic
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TABLE OF CONTENTS
ABSTRACT................................................................................................................................................4
CHAPTER 1................................................................................................................................................5
1.0 INTRODUCTION..............................................................................................................................5
1.1 BACKGROUND INFORMATION...................................................................................................5
1.2 STATEMENT OF THE PROBLEM...............................................................................................6
1.3 STUDY JUSTIFICATION..............................................................................................................7
1.4 OBJECTIVES..................................................................................................................................8
1.1.1 Broad Objectives.....................................................................................................................8
1.1.2 Specific Objectives..................................................................................................................8
CHAPTER 2................................................................................................................................................9
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ABSTRACT
Globally, an estimate of close to 462 million persons are affected by diabetes type 2, this
corresponds to 6.28% of the world’s population. More than 1 million deaths were attributed to
this condition in 2017 alone, ranking it as the ninth leading cause of mortality. This is an
alarming rise when compared with 1990, when type 2 diabetes was ranked as the eighteenth
leading cause of deaths. In terms of human suffering, diabetes ranks as the seventh leading
disease. Sub-Saharan Africa has lower prevalence of diabetes about one in twenty people than
does any other major region. However, first impressions would be dangerously wrong: the
estimated prevalence of undiagnosed diabetes is 62%, and an estimated 75% of deaths from
diabetes happen in people aged younger than 60 years. Furthermore, the number of people
affected is projected to rise from 21 million to 35 million during the next 20 years, which we
believe might prove a serious underestimate. 3.1 to 11.8% of persons with diabetes, or 12.9
million to 49.0 million persons worldwide and 1.0 million to 3.5 million in the United States
alone, have a history of foot ulceration. The lifetime incidence of foot ulcers has previously been
estimated to be 15 to 25% among persons with diabetes, but when additional data are
considered, between 19% and 34% of persons with diabetes are likely to be affected The
challenge in treating diabetic ulcer is diabetic foot infections secondary to Diabetic foot ulcer.
The study to be conducted; characterization of bacterial pathogens among diabetic patients with
wound infection will give the most effective antimicrobials and there resistant patterns. This will
update clinicians in the various antimicrobial alternatives available in treatment of
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wound infections specifically diabetic foot infection which will eventually help in
better management of diabetes. This study will be conducted within a 3 months period and we
will employ analytic observational cross-over design. A cross- over design is a controlled trial
where each study participant has both treatments i.e is randomized to initial treatment first
CHAPTER 1
1.0 INTRODUCTION
The endemic of diabetes mellitus and its complications poses a major global health threat. The
international Diabetes Federation (IDF) estimated that 1 in 11 adults aged between 20- 70 years
(415 million adults) had diabetes mellitus in 2015. This estimate is projected to rise to 642
million in 2040 and the largest increase will come from region experiencing economic transitions
from low-income level to middle-income (Zheng et al, 2017).
Diabetic patients because of hyperglycaemia can contribute to impaired wound closure hence
development of diabetic foot ulcers (DFUs). Diabetic foot ulcers are susceptible to foot
infections primarily because of neuropathy, vascular insufficiency and diminished neutrophils
function (Hanefeld et al, 2013).
Most diabetic wounds have the bacterial infection because hyperglycaemia of the wound bed
provides an ideal environment for the growth of microorganisms which can make the bacteria to
develop into a biofilm after attachment, which drives wound into a long lasting inflammatory
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phase once the biofilm is formed. A wound delay healing and may cause wound breakdown,
herniation of the wound and complete wound dehiscence (Gao et al, 2021).
In Kisumu it is estimated about 300 in every 10,000 diabetic patients have wound infection that
suffer from bacterial infections. This number could be higher because most cases goes
unreported. Therefore this study aims at documenting various characteristics of various bacterial
pathogens among diabetic patients to bring to light the common bacterial pathogens in diabetic
wounds and bacterial pathogens that may be resistant to drugs in order to formulate better
management for diabetic wound patients.
Diabetic foot ulcers (DFUs) are a prevalent complication of diabetes mellitus and account
for significant morbidity, mortality, and healthcare expenditures. It is estimated that 19–34%
of patients with diabetes are likely to be affected with a diabetic foot ulcer in their lifetimes,
and the International Diabetes Federation reports that 9.1–26.1 million people will develop
DFUs annually.
Most wound infection suffers bacterial pathogens infection. Most of which may be drug
resistance, emergence of resistance to antimicrobial agent is becoming a major public health
problem worldwide, in Africa this antimicrobial resistance cases are highlighted on WHO list of
priority AMR (Antimicrobial Resistant) bacteria for which new research, discovery and
development of new antibiotics are highly needed (Munita & Arias, 2016).
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1.3 STUDY JUSTIFICATION.
According to Neville et al it is estimated that 15-25% of the diabetic patients develop diabetic
foot ulcer in their life time and 50% of these DFU (Diabetic Foot Ulcer) develops to Diabetic
Foot Infections. Patients who have developed diabetic foot infections are usually hospitalised
multiple times and are usually exposed to multiple courses. The government has made an effort
through documentation of diabetes prevalence statistics but have not made any effort towards
documentation of the available antibiotics regimen specifically for Diabetic Foot Infections and
the antimicrobial resistant patterns.
The study to be conducted will give the most effective antimicrobials and there resistant patterns.
This will update clinicians in the various antimicrobial alternatives available in treatment of
wound infections specifically diabetic foot infection which will help in better management of
diabetes. The data may also be adopted by hospital JOOTRH to lay basic foundation for
further extensive surveillance studies within the region.
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1.4 OBJECTIVES
Research Questions
(1) What is the occurrence of bacterial pathogens among diabetic patients with wound infection?
(2) What are the common bacterial pathogens that lead to septic wounds among diabetic patients
with wound infections?
(3) What are the common drugs resistant to bacterial pathogens among the diabetic patients?
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CHAPTER 2
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an individual having a BMI greater than 29 kg/m2. The relative risk of diabetes increases due to
increase fat which leads to insulin resistance consequently leading to type 2 diabetes (Ismail et al,
2021).
Minor wounds, cuts, and burns are a part of life, but for people with diabetes, they can cause
serious health issues. Diabetics develop wounds that are slow to heal or never heal and the
wounds which don’t heal well become infected which then can spread locally or to surrounding
tissue or bone, which may be fatal.
According to a study conducted in 2013, diabetes makes it more difficult for the body to manage
blood glucose levels. When blood glucose remains chronically high, it impairs the function of
white blood cells resulting in an inability to fight bacteria. Diabetes if not controlled is associated
with poor blood circulation implying lack of deliverance of nutrients to the wounds (Abbas et al,
2015).
Wound debridement involves removal of all necrotic and devitalized tissue that is incompatible
with healing, as well as surrounding callus. This aids in granulation tissue formation and re-
epithelialization and reduces plantar pressures at callused areas. Debridement also helps in
infection control, as devitalized tissues provide an environment for bacterial proliferation, act as
a physical barrier for antibiotics, and limit immune response to fighting infection (Lipsky et al,
2016).
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improve outcomes. Conversely, inappropriately treating with antibiotics, often in the setting of
fear of missing an infection, to reduce bacterial burden or prophylaxis (Abbas et al, 2015).
In most wound infections the causative pathogens originate from endogenous flora of the
patient’s skin, mucous membranes or hollow viscera. The most commonly isolated bacterial
pathogens are Staphylococcus aureus, Enterobacteriaceae, Coagulase Negative Staphylococci
(CoNS), Enterococci and Pseudomonas aeruginosa (Tchero et al, 2019
CHAPTER 3
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3.0 MATERIALS AND METHODS
Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH) commonly known to many
as Russia is located in Kisumu Central sub-county which have the followings wards Railways
Migosi, Shaurimoyo, Kondele, Nyalenda B and Millimani. Russia lies along Kisumu-Kakamega
highway between Kondele and Kibuye Market. This hospital mostly serves more than 100
districts and sub-district hospitals in Western Region of Kenya. Kisumu County’s population as
per 2009 National Census is 968,909. It receives annual Relief rainfall of 1200 – 1300mm with
precipitation mainly in the afternoon. In April Kisumu receives high precipitation of about
288mm with temperature of 27℃ . Economic activities within Kisumu county includes
subsistence farming, livestock keeping, fishing, rice farming, sugarcane farming, and small scale
trading. Kisumu County is reported by an economic survey conducted in 2014 to have a high
population of poor people and a poverty index of 39.9%.
Health in Kisumu County is provided by several institutions that are either private or government
funded. There is one teaching and referral hospital, 5 county referral hospital, 14 sub-county
hospitals, 74 dispensaries and 18 health centers’ in the county. Major health problems’ affecting
the region includes malaria, HIV, Diabetes among other several infections and other associated
problems.
This study will be conducted within a 3 months period and we will employ analytic
observational cross-over design.
A cross- over design is a controlled trial where each study participant has both treatments i.e is
randomized to initial treatment first.
This design will be appropriate since the main interest will be to observe the outcome in each
measurement with all subjects serving as own controls and error variance. This will help reduce
sample size needed and further statistical tests assuming randomization can be used
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The targeted study population will be all diabetics attending diabetic clinic in the JOOTRH
hospital who have got wound infections. All diabetics with wounds sent to the laboratory for
wound culture and sensitivity will be the target regardless of gender, age, sex or any other factor.
Only diabetics with wound infections sent to the laboratory for pus swab culture and sensitivity
will be included in the study. Non diabetic wound patients for pus swab culture and sensitivity
sent to the laboratory will be excluded in the study.
The sampling design employed in the study is purposive sampling since it focuses only on
diabetics specifically with wounds.
Sample size for this study will be calculated using the following formula quotation (Fisher et
al, 1998).
n = Z2p (1-p)/ E2
p- expected prevalence
1.962 x 0.66(1-0.66)
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0.052 =
344 samples
Data will be analyzed using Calculators, Windows Excel and Statistical Packages for Social
Sciences. This will be represented in histograms and Bar Graphs.
Consent to involve the clients in the study will obtained from the clients on the onset of
research and information collected treated with utmost confidentiality. They will informed
that the results of the research shall be used for academic purposes and also in updating
clinicians on their empiric therapy.
Samples will be obtained while ensuring the most minimal harm to the study participants.
The study to be approved by Jaramogi Oginga Odinga Teaching and Referral Hospital
ethical review committee and permission to conduct this study to be obtained from the
hospital administration.
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REFERENCES
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Yan Zheng, Sylvia H. Ley & Frank B. Hu (2017) Global aetiology and epidemiology of type 2
diabtes mellitus and its complications.Nature Review Endocrinology volume (14) , 88-92.
WM Macharia, C Mbaabu, L Wachira, SOM Muhudhia, G Moniz (2005) Cefriaxone or Hiv
associated angio Africa Medical journal DOI: 10.4314/eamj.v82i11.9416
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