Surgery is one of the major and of import subdivision of medical specialty that perform a surgical process to the human organic structure for diagnostic, intervention, bar every bit good as alleviative intent. When a portion of the organic structure is operated during surgical process, the microorganism will take this chance to acquire into this lesion and multiply in tissues doing a post-operative infection. And such infection occurred post-operatively referred as surgical site infection.
The term ‘surgical site infection ‘ ( SSI ) was introduced in 1992 to replace the old term ‘surgical lesion infection ‘ ( Horan et al. , 1992 ) . Surgical site infection ( SSI ) is defined as an infection that occurs at an scratch site, or any portion of the anatomy that was opened or manipulated during the process that occurs within 30 yearss after surgery, or within 1 twelvemonth in the presence of an implant ( Horan et al. , 1992 ) .
Since the debut of antiseptic technique on manus wash by Dr. Ignaz Philipp Semmelweis ( Wikipedia ) , Louis Pasteur ‘s source theory surveies ( Wikipedia ) and Joseph Lister, 1st Baron Lister on lesion cleansing and surgical instruments sterilisation by utilizing carbolic acid ( Wikipedia ) , the SSI mortality and morbidity rates was reduced up to 90 % . The find of antibiotic substance penicillin by Sir Alexander Fleming ( Nobelprize.org ) further reduced the incidence of SSI.
However, SSIs remain a important clinical job as they are associated with considerable morbidity and mortality and it impose several demands on healthcare resources. SSI history for about 20 % -25 % of entire Hospital Acquired Infections ( HAI ) , it can duplicate the length of infirmary stay, cut down the lesion mending procedure and increase the cost of wellness attention. In the most unpleasant instance, it can take to re-operation and cut down the patient ‘s quality of life.
Anaerobic bacteriums are the major causative agents for the incidence of SSIs because the most common stray micro-organism from the site of infections are Staphylococcus aureus ( included Methicillin-resistant Staphylococcus aureus ) , Enterococcus spp, and Escherichia coli ( Leaper, 2010 ) . The common beginnings of pathogens is the endogenous vegetations ( FARIDA JAMAL MBBS, 1981 ) of the patient ‘s tegument, mucose membrane or hollow entrails.
There were many surveies on bar of the surgical site infections had provided some new thoughts, ideas, new methods on bar, and uncovering some methods were non necessary as they did non assist in forestalling the surgical site infection. Therefore another new guideline was published by Centers for Disease Control and Prevention ( CDC ) on 1999 to replace the guideline version 1985 ( Alicia J. Mangram, April 1999 ) .
A survey showed that about 500,000 SSIs occur in United States ( US ) each twelvemonth, and it causes of reduced patient ‘s quality of life, disablement, and even decease ( CG. , 2004 ) . An norm of 7-12 yearss excess infirmary corsets, or readmission due to SSI and subsequent interventions are required for SSI has increased the economic load of authorities, from USD $ 3,000 to USD $ 5,000 per patient ( Kathryn B. Kirkland et al. , 1999 ) . Operative patients developed SSI has greater hazard of decease compared to operative patients without SSI.
Chapter 2 – LITERATURE REVIEW
2.1 Signs of SSI
The common marks and symptoms presence in surgical site infection:
Fever, from moderate to high class febrility. A low class febrility on the first 2 yearss is common due to physiological respond following surgery.
Foul smelling drainage or Pus from the lesion. It can be bloody, light-green, milky, xanthous or assorted colorss. The drainage may be foaming or midst.
Swelling of the lesion, sometime can experience indurating as the tissue underneath are inflamed.
Inflammation of the environing tegument around the lesion, sometime may even experience warm.
Pain around the lesion. Normally the hurting is steadily and easy diminished during mending procedure, but if the hurting additions for no ground, likely there is an infection developing in the lesion.
The symptoms nowadays on the first 48-72 hours are normally normal physiological respond following surgery due to the healing procedure, but if they symptoms go terrible and worsen, so we should surmise the infection.
2.2 SSI Classification
The SSI can be divided harmonizing to the site of scratch:
Degree centigrades: UsersJL WongDesktopSSIssi.JPG
Figure 2.2 The image above show the cross subdivision of abdominal wall of the CDC Classifications of SSI ( Horan et al. , 1992 ) .
Superficial incisional SSI involved the superficial soft tissues which are skin and hypodermic tissue, Deep incisional SSI involves deep soft tissue, which are fascia and musculus under the hypodermic tissue, while Organ infinite SSI involve the variety meats, for illustration bowel, lien, liver, kidney, lungs, bosom, bone and other variety meats.
2.3 Surgical Wound Classification
The surgical lesion has been classified into 4 classs:
Table 2.3 Surgical Wound Classification
An clean secret agent lesion in which no redness is encountered and the respiratory, alimental, venereal, or clean
urinary piece of land is non entered. In add-on, clean lesions are chiefly closed and, if necessary, drained with closed drainage. Operative incisional lesions that follow nonpenetrating ( blunt ) injury should be included in this class if they meet the standards.
An operative lesion in which the respiratory, alimental, venereal, or urinary piece of lands are entered under controlled conditions and without unusual taint. Specifically, operations affecting the bilious piece of land, appendix, vagina, and oropharynx are included in this class, provided no grounds of infection or major interruption in technique is encountered.
Open, fresh, inadvertent lesions. In add-on, operations with major interruptions in unfertile technique ( e.g. , unfastened cardiac massage ) or gross spillage from the GI piece of land, and scratchs in which ague, non-purulent redness is encountered are included
in this class.
Old traumatic lesions with maintained devitalized tissue and those that involve bing clinical infection or perforated entrails. This definition suggests that the beings doing postoperative infection were present in the operative field before the operation.
( Alicia J. Mangram, April 1999 )
2.4 Hazard Factors
A figure of patient-related and procedure-related factors have been shown in univariate or multivariate analyses to act upon the hazard of SSIs
Table 2.4 Hazard factors that impacting the SSI
Patient related factors
Procedure related factors
Age, e.g. advanced age and utmost age
Nutritional position, e.g. malnutrition and recent weight loss
Uncontrolled blood sugar degree, e.g. Diabetes Mellitus
Altered immune position, e.g. HIV/AIDS, chronic steroid usage, old chemo/radio-therapy
Length of pre-operative infirmary stay
Co-existent infection at other portion of the organic structure
Colonization with microorganisms ( peculiar Staphylococcus aureus )
Duration of surgical chaparral
Preoperative tegument readying
Duration of operation
Operating room airing
Inadequate sterilisation of surgical instruments
Foreign stuff in the surgical site
failure to kill dead infinite
( Alicia J. Mangram, April 1999 )
Harmonizing to the survey at 1996, it shows that mild perioperative hypothermia, which is common during major surgery, may advance surgical-wound infection by triping thermoregulatory vasoconstriction, which decreases hypodermic O tenseness ( ANDREA KURZ, May 1996 ) . Reduced degrees of O in tissue impair oxidative violent death by neutrophils and diminish the strength of the healing lesion by cut downing the deposition of collagen ( ANDREA KURZ, May 1996 ) . Hypothermia besides straight impairs immune map ( ANDREA KURZ, May 1996 ) . However, there are still missing of clinical informations to back up that the patient ‘s organic structure temperature will increase the hazard of SSI.
Hyperglycemia impairs the unsusceptibility system of the patient. High blood sugar lead to non-enzymatic glycation of proteins that can demobilize the Immunoglobulin G ( IgG ) by diminishing complement arrested development and increase collagenase activity ( Hennessey et al. , 1991 ) . Hyperglycemia besides impaired the leucocyte maps which lead to detain of chemotaxis, impair phagocytosis and hinder bacteriocidal activity ( Mowat and Baum, 1971 ; Chang, 1979 ) .
2.5 SSI Prevention Bundle
SSI is a preventable surgical complication. Properly using the SSI bar package can cut down the hazard of SSI. SSI package is included the followers ( Team, 10 March 2008 ) :
If at all possible avoid hair remotion, otherwise use pick or limiter instead than usage razors ( Institute, 2007 ; Quality Medical Care Section, 2010 ) . Survey shows that remotion of the hair around the planned scratch site by razor or shaving increase the incidence of lesion infection when it compared with no hair remotion at all due to the hurt of the superficial tegument by razor.
Ensure contraceptive antibiotic was prescribed as per local antibiotic policy, for the specific operation class. If antibiotic is required, guarantee the antibiotic was been administered within 60 proceedingss prior to the operation to guarantee maximal tissue concentration, because one time the scratch is made, bringing of the antibiotics to the lesion is impaired ( Organization, 2009 ) .
Ensure the patient ‘s organic structure temperature was normal throughout the operation ( excludes cardiac patients ) ( ANDREA KURZ, May 1996 ) .
Ensure the patient ‘s blood glucose degree was normal throughout the operation ( diabetic patients merely ) ( Kazuhiro Hanazaki, 7 September 2009 ; Mowat and Baum, 1971 ; Chang, 1979 ; Hennessey et al. , 1991 ; Quality Medical Care Section, 2010 ) .
Extra bar can be done in pre- , intra- , and post-operative stages to forestall the incidence of SSI.
2.5.1 Pre-operative Phase
Nasal showing and decolonisation
Patient will be screen for Methicillin-resistance Staphylococcus Aureus ( MRSA ) by utilizing local guidelines and decolonized prior to surgery if found positively.
Patient should hold shower, or bath or at least wash, if unable to lavish, by utilizing soap to cut down the tegument microflora ( Quality Medical Care Section, 2010 ) .
2.5.2 Intra-operative Phase
Use 2 % Chlorhexidine gluconate in 70 % Isopropyl intoxicant and let to aerate dry instead than utilizing povidone-iodine, unless patient is allergic to Chlorhexidine gluconate.
It should be impregnated with antiseptic, if utilizations.
Patient ‘s haemoglobin impregnation rate should be maintain above 95 % throughout the full operation every bit good as post-operative stage.
2.5.3 Post-operative Phase
The lesion is covered with an synergistic dressing at the terminal of surgery and it should be kept undisturbed for a minimal 48 hours post-operatively for lesion healing, unless there is any escape. The rule of antisepsis ( non-touch technique ) is used when the lesion is being re-dressed.
Hand should be decontaminated instantly before and after each episodes of patient contact.
2.6 Problem Statements
There are no new updates on surgical site infection bar guideline for the past 13 old ages
There are deficiency of similar recent surveies in Malaya
Based on the old surveies shows that different infirmaries has different rates of surgical site infection, and all these are due to differences in clinical pattern, infirmary protocol, geolocation of the infirmary, populations and other factors.
Due to different hazard of bacterial taint in different surgical process, the surgical site infection rates are vary excessively.
2.7 Justification of the Study
Most of the clip, our local informations consist of merely those who acquired the infection while in the infirmary. SSI can develop infection within one month station operatively. Therefore those who get the infection after discharged might non be captured by infection control squad.
In this survey we would wish to find the prevalence of SSI among clean and clean contaminated surgery in HUSM because we thought that there is under describing of SSI because to day of the month there is no information available yet sing SSI. Knowing the incidence is important to develop infection control policy for SSI. Therefore we plan to make a prospective cohort survey to turn to this issue.
In this survey the patient will be proctor till one month station op to govern out SSI. Furthermore, a cohort prospective survey will enable us to make luxuriant profiles of the patient who develop SSI and place the jobs with respects to preoperative readying, during operation, post-operative lesion attention and carbon monoxide morbid unwellness associated with SSI.
Determining the causative agents and cognizing the antimicrobic profiles are important before we can develop a good antibiotic policy for antimicrobic prophylaxis and intervention of SSI.
Antibiogram is alone to every centre and we should non follow other policies without analyzing our ain profiles. To farther perplex the affair, most of the SSI diagnosed at outpatient clinic do non hold specimen taken for civilization. On the other manus, those who have specimens taken for civilization were non able to observe the causative being.
Therefore in this survey, we will give stress on the specimen aggregation and processing to find the best specimen and the causative agents. A
2.8 Research Questions
What is the incidence of SSI in our clean and clean contaminated lesion in our infirmary?
What are the common beings and their antibiogram profile of causative agents for SSI in our population?
What is the best method for specimen aggregation to acquire the best output of the causative beings
What are the preoperative, operative and postoperative patterns every bit good as carbon monoxide morbidities normally associated with SSI in our population.
What is the antibiogram of the causative agents and are we utilizing the suited antimicrobic prophylaxis based on our local antibiogram?
How did our population acquire infected? Did the beings come from the same ringer?
2.9 Objective of Study
To find the prevalence of SSI among clean and clean contaminated surgery in HUSM.
To place the hazard factors of SSI among clean and clean contaminated surgery in HUSM
To depict the microbiological profile of the causative micro-organisms and their antibiotic sensitiveness form.
To reexamine the antibiotic prophylaxis for clean contaminated surgery based on the consequence of the antibiogram.
To find the antimicrobic prophylaxis normally used in our infirmary.
To find the molecular word picture of MRSA strain doing SSI in clean and clean contaminated surgery.
Chapter 3 – Methodology
3.1 Study Design
Prospective cohort survey
3.2 Study Area
The survey will be done in tertiary-care infirmary, Hospital Universiti Sains Malaysia ( HUSM ) , Kubang Kerian, Kelantan. Patients are recruited in Department of Surgery in HUSM. The survey will be conducted for a continuance of 2 old ages.
3.3 Study Population
All patients underwent clean and clean-contaminated elected operation.
3.4 Sampling Method
Universal trying method – take all eligible population in one twelvemonth.
3.5 Sampling Frame
All patients fulfill the inclusion and exclusion standards.
3.6 Inclusion and Exclusion Criteria
Table 3.6 Inclusion and Exclusion Criteria of SSI
Underwent clean operations
Underwent clean-contaminated operations
Underwent contaminated operation
Underwent dirty-infected operation
Operationss that involve nidation
Sample Size Calculation
ZI± = 1.96 ( from I± = 0.05 )
P = Prevalence rate from old survey
a?† = Precision ( run 0.01-0.15 )
Formula for ciphering the prevalence rates ( individual proportion ) .
Prevalence of clean surgery ( Patel Sachin M, April-June 2012 )
Prevalence of clean-contaminated surgery ( Patel Sachin M, April-June 2012 )
Hazard factors are calculated by utilizing PS Power and Sample Size Calculations version 3.0, January 2009, by William D. Dupont and Walton D. Plummer.
Risk factor – Fleshiness ( Arabshahi Ks Fau – Koohpayezade and Koohpayezade )
I± = 0.05 power = 0.8 P0 = 0.074 P1 = 0.23 m = 1
experimental topics = 82 + 82 control topics
= 164 sample size
Risk factor – Diabetes Mellitus ( Arabshahi Ks Fau – Koohpayezade and Koohpayezade )
I± = 0.05 power = 0.8 P0 = 0.071 P1 = 0.23 m = 1
experimental topics = 78 + 78 control topics
= 156 sample size
Risk factor – Smoke ( Arabshahi Ks Fau – Koohpayezade and Koohpayezade )
I± = 0.05 power = 0.5 P0 = 0.073 P1 = 0.23 m = 1
experimental topics = 81 + 81 control topics
= 162 sample size
Sample size will be taken from clean and clean-contaminated surgery which is 50 and 171, so the entire sample size will be 221 topics.
3.8 Sample Collection ( Patient Selection )
Patient will be placing from elected OT list. Consent will be taken. Nasal swab for MRSA colonisation showing will be performed. Patient demographic informations will be filled in. Patient will be follow up during pre- , intra- and post-operatively up to 30 yearss. At any clip during 30 yearss continuance, if patient have grounds of infection at his/her surgical site, the specimens ( Pus aspirates, tissue or swab ) will be collected and direct for microbiological analysis.
3.9 Sample Collection for Microbiological Analysis
Sample will be collected from patients developed surgical site infection. All lesions will be cleaned by Chlorhexidine. Then the Pus, exudation or fluids will be aspirated. Tissue deletion from the lesion border by scalpel will be done where the aspiration is non possible.
If aspiration and tissue sample are non possible, swabs from the deepnesss of the lesion will be used.
3.10 Sample Transport
All the samples will be placed into an aerophilic conveyance device or a unfertile tubing, and placed into a sealable plastic bag. Then conveyance to the microbiological research lab within 2 hours from the clip of aggregation.
3.11 Study Tools
Blood agar ( BA ) media home bases
MacConkey ( MAC ) media home bases
Chocolate blood agar ( CBA ) media home bases
Gas jar / plastic pouch
Anaerobic gas battalion
Selective media home bases ( Mueller Hinton with 4 % NaCl + 6mcg oxacillin )
Antimicrobial sensitiveness trial phonograph record
Incubator in 35 grade celcius
Incubator with Carbon dioxide in 37 grade celcius
3.12 Laboratory Methods
Bacterial civilization method
Antimicrobial susceptibleness trial
Polymerase Chain Reaction ( PCR )
3.12.1 Gram discoloration
Put 1 little bead of saline on glass slide
Put the sample on the glass slide and repair it
Flood the vilification with crystal violet solution and delay for 1 minute
Rinse off the Crystal Violet solution with tap H2O
Flood the vilification with Iodine solution and delay for 1 minute
Rinse off the Iodine with tap H2O
Bleach the vilification by adding Acetone solution and delay for 15 seconds
Rinse off the Acetone with tap H2O
Counterstain with Safranin solution and delay for 30 seconds
Rinse off the Safranin with tap H2O
Let it air dry
Examine under light microscope with power 10
Examine with power 100 with a bead of oil on the vilification
Grame positive is Blue coloring material and Gram negative is Red coloring material
3.12.2 Nasal swab
Streak the sample on BA home base and Mueller Hinton agar + 4 % NaCl + Oxacillin home base and set into an enclosed plastic bag with anaerobiotic gas battalion to make an anaerobiotic environment and topographic point it into brooder.
Both home bases will be examined by utilizing gm discoloration after 24 hours of incubation period.
3.12.3 Pus aspirate
Use a cotton bud to take the Pus from the container and topographic point on a little portion of 2 blood agar home bases, MacConkey home base, cocoa blood agar home base and glass slide for gm discoloration, so we use unfertile cringle to streak on the sample on petri home bases.
Then we put the CBA home base into brooder with Carbon dioxide, 1 BA home base and the MAC home base into brooder and 1 BA home base put into an enclosed plastic bag with anaerobiotic gas battalion to make an anaerobiotic environment and topographic point it into brooder.
We stain the vilification with gm discoloration and we will look for the Pus cell and epithelial cell under light microscope.
CBA home base will be examined by utilizing gm discoloration after 48 hours of incubation period while other home bases will be examined by utilizing gm discoloration after 24 hours of incubation period.
Use a cotton bud to take the Pus from the container and topographic point on a little portion of 2 blood agar home bases, MacConkey home base and glass slide for gm discoloration, so we use unfertile cringle to streak on the sample on petri home bases.
Then we put 1 BA home base and the MAC home base into brooder and 1 BA home base put into an enclosed plastic bag with anaerobiotic gas battalion to make an anaerobiotic environment and topographic point it into brooder.
We stain the vilification with gm discoloration and we will look for the Pus cell and epithelial cell under light microscope.
All home bases will be examined by utilizing gm discoloration after 24 hours of incubation period.
3.12.5 Wound swab
Streak the sample on BA home base and MAC home base and allow the micro-organisms grow in brooder for 24 hours and so analyze by utilizing gm discoloration.
3.12.6 Biochemical Test – Citrate Trial
This trial is used for testing the ability of bacteriums to use citrate as its energy and C beginnings. Streak an stray pure civilization onto its surface and incubate at 35 degree Celcius for 18 to 48 hours. Then observe the coloring material changing.
Citrate “ positive ” is bluish coloring material and no coloring material altering in citrate “ negative ” , which is its original green coloring material. Positive consequence indicate the presence of Gram-negative pathogen.
3.12.7 Biochemical Test – Indole Trial
This trial is to find the ability of bacteriums to divide indole from amino acid tryptophan. Stab an stray pure civilization to the underside and incubate at 35 degree Celcius for 24 to 48 hours. After that add 5 beads of Kovac ‘s reagent.
Indole “ positive ” is red-voilet coloring material and indole “ negative ” is xanthous coloring material while orange coloring material is due to tryptophan debasement.
Indole “ positive ” bacteriums includes:
most Citrobacter spp.
Proteus spp. ( non P. Mirabilis )
Indole “ negative ” bacteriums includes:
most Bacillus spp.
most Haemophilus spp.
most Klebsiella spp.
3.12.8 Biochemical Test – Methyl Red ( MR ) Trial
This trial is used to place bacteriums bring forthing stable acids by mechanisms of assorted acerb agitation of glucose. Take an stray pure civilization with a cotton bud and assorted it with Methyl-red solution, so incubate for 48 hours at 37 degree celcius.
Positive consequence is pH & lt ; 4.4 in ruddy coloring material, negative consequence is pH & gt ; 6.2 in xanthous colour while in between is orangish coloring material.
Positive consequence indicates the presence of Escherichia coli.
3.12.9 Biochemical Test – Triple Sugar Iron ( TSI ) Trial
TSI angle is a trial tubing that contains 1 % milk sugar, 1 % saccharose and 0.1 % glucose. This trial is used in finding the saccharide agitation and H2S production. This trial is most often used for placing Enterobacter, every bit good as other gm negative bacteriums. Stab with an stray pure civilization to the underside and run on the surface and isolated for 18 to 24 hours at 37 degree celcius.
Table 3.12.9: Interpretation of Triple Sugar Iron Test
Glucose agitation merely
Glucose and lactose and/or sucrose agitation
Yellow + bubbles
Glucose and lactose and/or sucrose agitation, Gas produced
Yellow + bubbles
Glucose agitation merely, Gas produced
Yellow + bubbles
Glucose agitation merely, Gas produced, H2S produced
Yellow + bubbles
Glucose and lactose and/or sucrose agitation, Gas produced, H2S produced
Glucose agitation merely, H2S produced
Glucose and lactose and/or sucrose agitation, H2S produced
3.12.10 Biochemical Test – Urease Trial
This trial is to place the microorganism that are capable of hydrolysing urea to bring forth ammonium hydroxide and C dioxide. It ‘s chiefly used to separate urease-positive Proteeae from other Enterobacteriaceae. Streak an stray pure civilization onto its surface and incubate at 35 degree Celcius for 18 to 24 hours. Then observe the coloring material changing.
Positive consequence present with bright pink coloring material on the angle.
3.12 Data Analysis
Data will be collected, summarized, tabulated, and analyzed utilizing IBM Statistical Package for the Social Sciences ( SPSS ) package. The consequences will be presented through histograms, tabular arraies, Chi-square trial and pie charts.
3.13 Ethical Consideration
Ethical blessing will be taken from USM Research Ethics Committee ( Human ) – ( JEPeM ) for sample aggregation. Informed consent will be signed by the take parting patients or their relations.
Get the operation theater listStudy Flow Chart
Patient discharged from the survey
No grounds of infection
Evidence of infection ( febrility, pussy discharge, hurting )
Follw up the patient on the twenty-four hours 30 post-operatively at OPD
Continue follow up by phone on 3rd hebdomad
2 hebdomads follow up during sutura to open ( STO ) at Out-Patient Department ( OPD )
Identifying the pathogen ( Microscopic. Biochemical, PCR )
Isolation of the pure civilization
Take sample from the site of scratch
Fill up intra- , post-operation checklist
Fill up patient personal informations ( name, age, gender, reference, contact figure etc ) and pre-operation checklist
Patient in ward
Patient underwent operation
Nasal swab for testing MRSA colonisation
Get the consent signifier signed by the patient
Gantt Chart of Research Activities for:
SURGICAL SITE INFECTIONS AMONG PATIENTS UNDERWENT CLEAN AND CLEAN CONTAMINATED SURGERY IN HUSM: Hazard FACTORS, MICROBIOLOGICAL AND MRSA MOLECULAR PROFILE
Designation of micro-organisms and their antibiotic sensitiveness forms are performed
Statistical Data Analysis
Report Writing, Presentation and Submission of Report
Submission of Research Papers for Publication
December 2013: Will finish the patients enlisting
March 2014: Will finish the informations aggregation and designation of micro-organisms and their antibiotic sensitiveness forms
July 2014: Will finish the statistical informations analysis
October 2014: Will finish the study authorship, presentation and entry of study
February 2015: Report will be published