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Sam Proposal

Uploaded by

Zablon Kodila
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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KISII NATIONAL POLYTECHNIC

DEPARTMENT OF HEALTH SCIENCES

TITLE:

CHARACTERIZATION OF BACTERIAL PATHOGENS IN DIABATES MELLITUS


PATIENTS WITH DIABETIC FOOT INFECTIONS ATTENDING JOOTRH FROM
DECEMBER 2022 TO MARCH 2023

SAMWEL OMONDI OTIENO


UDMLTJ22/013.

“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

1
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

1
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

2
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

3
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

1.1 BACKGROUND  INFORMATION.


Diabetes is a chronic disease that occurs either when the pancreas does not produce enough
insulin or when the body cannot effectively use the insulin it produces (Ozougwu et al,2013),
this largely result to excess body weight and physical inactivity(Gold & Briefel, 2007)

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).

In Africa the prevalence of diabetic wound ranges from 3.2% - 19.1 % (4-10). Kenya is ranked


no. 31st country in Africa according to International Diabetic Federation with prevalence of about
460 in 10,000. Diabetes is rising at an alarming rate primarily due to change in lifestyle due to
increased consumption of unhealthy diets (Katambo, 2021).

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

4
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.

1.2 STATEMENT OF THE PROBLEM


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; these which we believe might prove a
serious underestimate. The challenge of diabetes faced by sub-Saharan Africa is enormous, and
will get rapidly worse if effective measures are not taken (Onyango & Onyango, 2015).

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).

5
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.

6
1.4 OBJECTIVES

1.1.1 Broad Objectives


To characterize bacterial pathogens among diabetic patients with wound infection attending
Jaramogi Oginga Odinga Teaching and Referral Hospital.
  

1.1.2 Specific Objectives


(1) To determine the occurance of various bacterial pathogens among diabetic patients
attending Jaramogi Oginga Odinga Teaching and Referral Hospital.
(2) To determine the common bacterial pathogens that lead to septic wounds among diabetic
patients with wound attending Jaramogi Oginga Odinga Teaching and Referral Hospital.
(3) To establish drug resistance occurrence of bacterial pathogens among patients attending
Jaramogi Oginga Odinga Teaching and Referral Hospital clinic.

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?

7
CHAPTER 2

2.0 LITERATURE REVIEW

2.1 EPIDEMIOLOGY OF DIABETES TYPE 2


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 (Khan et al ,
2019). 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,3 which we believe might prove a
serious underestimate. The challenge of diabetes faced by sub-Saharan Africa is enormous, and
will get rapidly worse if effective measures are not taken (Onyango & Onyango, 2015).

2.2 Risk Factors for Diabetes


There are several risk factors that lead to development of type 2 diabetes these include; high level
of serum uric acid, smoking, dyslipidemia, ethnicity and cardiovascular disease. High level of
serum uric acid according to Perry et al, an individual having a uric acid level of more than 411
lmol/l is at 1.5 times more risk of developing type 2 diabetes compared to an individual having
uric acid level of less than 302 lmol/l. Niskanen et al. also confirmed that change in uric acid
levels is associated with a 2 times increase in the risk of incidence type 2 diabetes. Olsson et al
described Dyslipidemia as abnormal lipids such as cholesterol and triglycerides which
consequently leads to elevation of Low Density Lipoprotein (LDL) and lowered High Density
Lipoprotein (HDL) resulting to Beta-cell dysfunction inhibiting insulin secretion and
consequently type 2 diabetes. Young et al also examined close association between coronary heart
disease and type 2 diabetes and concluded that Coronary Heart Disease score is associated with
type 2 diabetes. Ishikawa-Takata et al. found that the risk of diabetes increases significantly for

8
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).

2.3 Diabetic wound

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).

2.4 Diabe tic Wound Treatment


Diabetic wound or diabetic foot ulcer treatment is based on three principles; local wound care
with surgical debridement, dressing which promotes a moist wound environment, wound off-
loading, vascular assessment, and treatment of wound which develops to infection.

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).

2.5 Infections in Diabetic Wound


Wound infection is a known predictor of poor wound healing and amputation. The appropriate
recognition of infection and treatment with antibiotics in diabetic foot infection is imperative to

9
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

2.6 Drug Resistance of Bacterial Pathogens in Wound Infection.


There has been an increase incidence of wound attributed to antimicrobial resistant pathogenic
bacteria like Methicillin resistant Staphylococcus aureus (MRSA) and Vancomycin resistant
Staphylococcus aureus. Studies recently conducted in East Africa, one cross-sectional survey
among 63 surgical patients at University teaching hospital in Kenya, reported that S. aureus was
the most frequently isolated pathogens (54.7%) while Proteus, Pseudomonas and Escherichia coli
were 15.5%, 11.9% and 2.3%, respectively (Macharia et al, 2005).

CHAPTER 3

10
3.0 MATERIALS AND METHODS

3.1 Study area

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.

3.2 Study design

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

3.3 Study population

11
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.

3.4 Inclusion and exclusion criteria

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.

3.5 Sampling design

The sampling design employed in the study is purposive sampling since it focuses only on
diabetics specifically with wounds.

Purposive sampling is a non-probability sample that is selected based on characteristics of a


population and the objective of the study. Also known as judgmental, selective, or subjective
sampling.

3.6 Sample size determination

Sample size for this study will be calculated using the following formula quotation (Fisher et
al, 1998).

n = Z2p (1-p)/ E2

n- minimum sample size

p- expected prevalence

e- corresponds to margin of error (precision), is 10%

Z- is standard deviation corresponding to two specified confidence interval is 1.96 (at


confidence interval 95%)

1.962 x 0.66(1-0.66)

12
0.052 =
344 samples

3.8 Data analysis and Presentation

Data will be analyzed using Calculators, Windows Excel and Statistical Packages for Social
Sciences. This will be represented in histograms and Bar Graphs.

3.9 Ethical considerations

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.

13
REFERENCES

Abdulrazak A, Bitar ZI, Al-shamali AA & Mobasher LA.(2005) Bacteriological study of


diabetic foot infections and diabetic complications Review 19 (3), 138-141.
Fisher, A.A., Laing, J.E., Stoeckel, J.E. and Townsend, J.W. (1998) Handbook for Family
Planning Operations Research Design.
Huidi Tchero, Pauline Kangambega, Sergiu Fluieraru, Farid Bekara, Luc Teot (2019) Ismail L,
Materwala H, Al Kaabi J. . (2021) Association of risk factors with type 2 diabetes: A systematic
review. Comput Struct Biotechnol J10;19:1759-1785. doi: 10.1016/j.csbj. PMID: 33897980;
PMCID: PMC8050730.
Katambo D(2021, June 23) Diabetes statistics in Kenya https://afyacode.com/diabetes-statistics-
in-kenya/
Munita JM, Arias CA. 2016. Mechanisms of antibiotic
resistance. Microbiol Spectrum 4(2):VMBF-0016-2015. doi:10.1128
/microbiolspec.VMBF-0016-2015
Munita JM, Arias CA. 2016. Mechanisms of antibiotic
resistance. Microbiol Spectrum 4(2):VMBF-0016-2015. doi:10.1128
/microbiolspec.VMBF-0016-2015
Munita JM, Arias CA. 2016. Mechanisms of antibiotic
resistance. Microbiol Spectrum 4(2):VMBF-0016-2015. doi:10.1128
/microbiolspec.VMBF-0016-2015
Munita JM, Arias CA (2016) Mechanisms of antibiotic resistance Microbial Spectrum 4(2)
VMBF-0016-2015
Ozougwu Jevas Obimba, K.C, Belonwu, C.D.,Unakalamba, C.B.(2013) The pathogenesis and
pathophysiology of type 1 and type 2 diabetes mellitus Academic Journals
Opota O, Croxatto A, Prod'hom G, Greub G (2015) Blood culture-based diagnosis of
bacteraemia: state of the art. Clinical microbiology and infection : the official publication of the
European Society ofClinical Microbiology and Infectious Diseases 2015, 21(4):313-322
Tchero H, Kangambega P, Fluieraru S, Bekara F, Teot L. (2019) Management of infected
diabetic wound: a scoping review of guidelines. F1000Res. 24;8:737. doi:
10.12688/f1000research.18978.1. PMID: 32528649; PMCID: PMC7265589
Williams DT, Hilton JR & Harding KG. (2004), Diagnosing foot infections in diabetes. Clin
Infect Dis. 2004;39 (suppl 2):S83-S86
Weigelt, J., A, Lipsky, B., A, Tabak, Y., P, Derby K., G, Kim & M Gupta V., (2010). Surgical
site infections: Causative pathogens and associated outcomes. American Journal Infection
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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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