11
Amit A. Desai*, Dnyanesh M. Belekar**, V. V. Dewoolkar*** Single Dose Antimicrobial Use in Clean and Clean Contaminated Surgical Wounds Prospective Open Control Trial (Of 100 patients) Abstract Introduction : Whenever antibiotics are given empirically, in a surgery, they should be used when local wound defenses are not established. Ideally, maximal blood and tissue levels of antibiotic should be present at the time, incision is made and also before contamination occurs. Continuation of antibiotics beyond the operative day increases the cost of treatment and may not be useful in reducing site infections. Many surgical units in various centres have their own protocols regarding use of antimicrobial drugs in the peri-operative period depending on their unit chief’s personal experience over years. These protocols may be very effective, although at times there is excessive use of ‘extra’ drugs. Sadly, many of these effective protocols are not documented. We now need unbiased evidence based proof of a particular drug protocol in surgical practice that is actually ‘useful’ for every centre. We have conducted a prospective and double blind open control trial in a tertiary care private hospital (single centre) over a period of six months. Aims and Objectives 1. To Compare the efficacy of peri-operative single dose antimicrobials against the extended antimicrobials in preventing surgical site infections. 2. To study the effect of factors, that influence surgical site infections, on these protocols. 3. To study the cost effectiveness of peri-operative single dose antimicrobials versus the extended dose antimicrobials. Introduction he ancient Egyptians were the first civilization to have trained physicians to treat physical ailments. Way back in 1510, the concept of wound healing appeared as a mystical craft and long associated with religious overtones which was highlighted in the famous saying by a T *Assi. Prof., **Asso. Prof., ***Dean and Prof., Dept. of Gen. Surgery, K. J. Somaiya Medical College, Hospital and Research Center, Sion, Mumbai-22. French military surgeon. In the days before Joseph Lister, an English surgeon (1827-1912) said, surgical patient commonly developed postoperative “irritative fever,” followed by purulent drainage from their incisions, overwhelming sepsis, and often death. Without antisepsis and asepsis major surgical operation had been ending in death, making surgeons helpless in dealing with wound infection. Lister 41 Bombay Hospital Journal, Vol. 53, Special Issue, 2011 370

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Amit A. Desai*, Dnyanesh M. Belekar**, V. V. Dewoolkar***

Single Dose Antimicrobial Use in Clean and Clean Contaminated Surgical Wounds Prospective Open Control Trial (Of 100 patients)

Abstract

Introduction : Whenever antibiotics are given empirically, in a surgery, they should

be used when local wound defenses are not established. Ideally, maximal blood and

tissue levels of antibiotic should be present at the time, incision is made and also

before contamination occurs.

Continuation of antibiotics beyond the operative day increases the cost of treatment

and may not be useful in reducing site infections.

Many surgical units in various centres have their own protocols regarding use of

antimicrobial drugs in the peri-operative period depending on their unit chief’s

personal experience over years. These protocols may be very effective, although at

times there is excessive use of ‘extra’ drugs. Sadly, many of these effective protocols

are not documented. We now need unbiased evidence based proof of a particular

drug protocol in surgical practice that is actually ‘useful’ for every centre.

We have conducted a prospective and double blind open control trial in a tertiary

care private hospital (single centre) over a period of six months.

Aims and Objectives

1. To Compare the efficacy of peri-operative single dose antimicrobials against the

extended antimicrobials in preventing surgical site infections.

2. To study the effect of factors, that influence surgical site infections, on these

protocols.

3. To study the cost effectiveness of peri-operative single dose antimicrobials

versus the extended dose antimicrobials.

Introduction

he ancient Egyptians were the first civilization to have trained physicians

to treat physical ailments. Way back in 1510, the concept of wound healing appeared as a mystical craft and long associated with religious overtones which was highlighted in the famous saying by a

T

*Assi. Prof., **Asso. Prof., ***Dean and Prof., Dept. of Gen. Surgery, K. J. Somaiya Medical College, Hospital and Research Center, Sion, Mumbai-22.

French military surgeon.

In the days before Joseph Lister, an

English surgeon (1827-1912) said,

surgical patient commonly developed

postoperative “irritative fever,” followed by

purulent drainage from their incisions,

overwhelming sepsis, and often death.

Without antisepsis and asepsis major

surgical operation had been ending in

death, making surgeons helpless in

dealing with wound infection. Lister

41Bombay Hospital Journal, Vol. 53, Special Issue, 2011370

introduced the principles of antisepsis

that decreased postoperative infectious

morbidity substantially. His work

radically changed surgery from an activity

associated with infection and death to a

discipline that could eliminate suffering

and prolong life.

Any infection that occurs at the site of a

surgical incision is called surgical site

infection. The New CDC-definitions for

surveillance of surgical site infections

(1992) take into account 3 classes of

surgical site infections (SSI) :

1. Superficial incisional SSI

2. Deep incisional SSI

3. Organ/space SSI

The most important host-related risk

factors for development of SSI are

advanced age, morbid obesity, disease

severity, an ASA (American Society of

Anaesthesiologist) score > 2, prolonged

preoperative hospital stay, and infection at

distal sites. Microbial contamination of the

surgical site occurs mainly during the

surgical intervention. Although exogenous

contamination may be of concern,

especially in clean operations, most

surgical site infections are caused by

endogenous microorganisms of the

patient’s own commensal flora. SSI rates

vary according to the type and duration of

the surgical procedure and the skill of the

surgeon. Aseptic surgical technique is the

most important factor in the prevention of

SSI. Modification of host risk factors

should be attempted whenever possible. In

addition, adequate protocols for

an t im i c r ob i a l p r ophy lax i s w i th

appropriate antibiotics should be followed.

Surveillance of surgical site infections is

probably beneficial for SSI prevention.

The basic principle of antibiotic

prophylaxis in surgery is to achieve

adequate serum and tissue drug levels

that exceed, for the duration of operation,

t h e M E C s ( m i n i m u m e f f e c t i v e

concentration) or the organism that are

likely to be encountered during the

operation.

The selection of an appropriate

antimicrobial agent depends on the

identification of the most likely pathogens

that are associated with a specific surgical

operation. The prolonged use of

prophylactic antimicrobials is associated

with the emergence of resistant bacterial

strains.

Surgical site infections are the second

most common cause of nosocomial

infections. In hospitals, patients who

develop surgical site infections are up to

60% more likely to spend time in an ICU, 5

times more likely to be readmitted to the

hospital and 2 times more likely to die than

are patients without any SSI. Prophylactic

antibiotics are effective in a wide range of

surgical procedures and have contributed

substantially in reducing post operative

wound infection rates. It has been

estimated that 33% to 50% of antibiotics

used in hospital is for surgical prophylaxis

rather than for treatment. Although

properly administered antibiotics can

reduce post operative SSIs secondary to

preoperative bacterial contamination, use

of broad spectrum antibiotics has

d i sadvantages o f emergence o f

multiresistant organisms. Therefore it is

essential to ensure the quality use of

surgical antibiotic prophylaxis, not only to

improve the drug therapy outcome but

a l s o t o p r e v e n t e m e r g e n c e o f

multiresistant organism strains.

Total 100 patients in each arm were

selected in the study group and control

group who had clean wounds. Patients

with contaminated wounds were excluded

Material and Methods

Bombay Hospital Journal, Vol. 53, Special Issue, 2011 371

from the study.

Patients in the study group received a

single dose of intravenous injection of

amoxycillin, in the operation theatre, just

prior to taking an incision.

The control group patients were given

injection ceftriaxone with sulbactum and

injection metronidazole intravenously

eight hourly for three days followed by

tablet cefixime eight hourly till removal of

sutures.

Anti-diabetic medications were

omitted on the day of surgery and an

insulin drip was started during surgery.

Antihypertensive drugs were given with

sips of water on the morning of surgery.

Immuno-compromised and Australia

antigen positive patients were operated

only on Saturdays in a separate operation

theatre and the operation theatre was

fumigated after the surgery. Shaving at the

operation site was done one hour prior to

surgery using a hair trimmer.

Pre-operative preparation of skin was

done by povidone iodine scrub, spirit and

5% povidone iodine solution.

Skin was sutured with No. 2/0 or 3/0

p o l y a m i d e ( n o n - a b s o r b a b l e ,

monofilament) sutures. Povidone iodine

dressing was given.

In case of discharge from the wound or

induration, the pus was drained and sent

for culture sensitivity.

Age of the patients

The youngest patient was 8 year old

and the eldest 89 year.

Serial Order of the surgery

Following were the serial orders of the

Results

surgeries performed in the study group :

Following were the serial orders of the

surgeries performed in the control group :

Average Cost of Treatment

The average cost of treatment for the

Co-morbid conditions : 1

Parameter

15

2

2

0

1

47

1

Study group

Obesity

HBsAg

HIV

Hypertensive

Alcoholic

Mesh

Drain

2

0

0

0

0

2

2

Infec-tion

16

0

1

3

0

29

13

Controlgroup

2

0

0

0

0

2

2

Infec-tion

Experience of the surgeon

32

46

14

9

Study group

QualifiedSeniors

QualifiedJuniors

UnqualifiedSeniors

UnqualifiedJuniors

3

1

0

0

Infec-tion

35

57

9

3

Controlgroup

0

3

0

0

Infec-tion

Experience

(> 5 yrs, postM.S)

(< 5 yrs, postM.S)

rd(3 yearResidents)

st nd (1 , 2 yearResidents)

Development of wound infection :

Total Number

Study Group

Control Group

100

100

4

3

Cases Wound Infection

Bombay Hospital Journal, Vol. 53, Special Issue, 2011372

Serial order on list

32

27

19

12

3

6

1

st1nd2rd3th4th5th6th7

Study group

1

2

0

0

0

1

0

Infec-tion

35

24

12

16

9

4

1

Controlgroup

1

0

1

1

0

0

0

Infection

study group, was Rs. 150/-, however for

control group was Rs. 1050/-

Statistics

Using Chi-Square Test

Since the observed value (0.1478) is

much lower, we conclude that the null

hypothesis is true and that there is not

much difference between the two protocols

of peri-operative antimicrobial drug

administration.

Discussion

Until the middle of the 19th century,

when Ignaz Semmelweis and Joseph Lister

became the pioneers of infection control by

introducing antiseptic surgery, most

wounds became infected. In cases of deep

or extensive infection this resulted in a 1mortality rate of 70-80%. Since then a

number of significant developments,

particularly in the field of microbiology,

have made surgery safer. However, the

overall incidence of healthcare associated

infections (HAIs) still remains high and

represents a substantial burden of

disease.

In 1992, the US Centers for Disease

Control (CDC) revised its definition of

‘wound infection’, creating the definition 2‘surgical site infection’ (SSI) to prevent

confusion between the infection of a

surgical incision and the infection of a

traumatic wound. Most SSIs are

superficial, but even so they contribute

greatly to the morbidity and mortality

3,4associated with surgery. Estimating the

cost of SSIs has proved to be difficult but

many studies agree that additional bed

occupancy is the most significant factor.

Surgical site infections are classified

into three groups -

• superficial and

• deep incisional SSIs and

• Organ-space SSIs - depending on

the site and the extent of infection.

The CDC definition states that only

infections occurring within 30 days of

surgery (or within a year in the case of

implants) should be classified as SSIs.

Incisional surgical site infections 2must meet the following two criteria :

• occur within 30 days of procedure

• Involve only the skin or

subcutaneous tissue around the

incision.

Superficial incisional SSI

Criteria as per Definition + at least

one of the following must be present :

• Purulent drainage, with or

without laboratory confirmation,

from the superficial incision.

• Organisms isolated from an

aseptically obtained culture of

fluid or tissue from the superficial

incision.

• At least one of the following signs

or symptoms of infection : Pain or

tenderness, localized swelling,

redness or heat.

• Diagnosis of superficial incisional

SSI by the surgeon or attending

physician.

Deep incisional SSI

Criteria as per definition + at least one

Culture of Wound Swab

S. aureus

Study Group

Control Group

2

2

Organism E. coli

1

0

Negative Culture

1

1

Bombay Hospital Journal, Vol. 53, Special Issue, 2011 373

of the following :

• Purulent drainage from deep

incision.

• A deep incision spontaneously

dehisces or is deliberately opened

by a surgeon when the patient has 0either – Fever (> 38 C), localised

pain or tenderness. An abscess or

other evidence of infection involving the deep incision is

found on direct examination,

during reoperation, or radiologic

examination.

• Diagnosis of deep incisional SSI

by a surgeon or attending

physician.

Note : Report infection that involoves both

superficial and deep incision sites

and an organ/space SSI that drains

through the incision as deep

incisional SSI.

Organ/space SSI

Criteria as per definition + at least one

of the following :

• Purulent discharge from a drain

that is placed through a stab

wound into the organ/space.

• Organisms isolated from an

aseptically obtained culture of

fluid or tissue in the organ/space.

• An abscess or other evidence of

i n f e c t i o n i n v o l v i n g t h e

organ/space that is found on

direct examination, during

reoperation, or by histopathology

or radiological examination.

• Diagnosis of an organ/space SSI

by a surgeon or attending

physician.

Aetiology : In a primary infection, the

wound is the primary site of infection,

whereas a secondary infection arises

following a complication that is not directly

related to the wound.

Time : An early infection presented

within 30 days of a surgical procedure,

whereas an infection is described as

intermediate if it occurs between one and

three months afterwards and late if it

presents more than three months after

surgery.

Severity : A wound infection is

described as minor if there is discharge

without cellulitis or deep tissue

destruction, and major if the discharge of

pus is associated with tissue breakdown,

partial or total dehiscence of the deep

fascial layers of the wound, or if systemic

illness is present.

Causes and Risk factors

• Bacterial factors : In our study 2

infections in the study group and

2 infections in the control group

were caused by staphylococcus

aureus (sensitive to Linezolid) and

one infection in the study group

was caused by E. coli (sensitive to

ciprofloxacin and ofloxacin). One

infection in each of the groups was

caused by organisms which could

not be cultured.

• Local wound factors : No

significant difference was noted in

our study, by drain or mesh

insertion on the incidence of local

wound infection in both groups.

• Patient factors : Obesity (B.M.I.

Bombay Hospital Journal, Vol. 53, Special Issue, 2011374

more than 30) predisposed the

patient to an increased risk of

wound infection in our study, but

a significant difference was not

seen between the study and

control group as far as prevention

of wound infection in the obese

patient is concerned.

Bacterial factors

vBacterial no., Virulence,

antimicrobial resistance.

vWound classification : A

system of classification for

operative wounds that is

based on the degree of

microbial contamination was

developed by the US National

Research Council group in 51964. Four wound classes

with an increasing risk of

SSIs were described : clean,

c l e a n - c o n t a m i n a t e d ,

contaminated and dirty. The

simplicity of this system of

classification has resulted in

it being widely used to predict

the rate of infection after

surgery.

vLength of preoperative

hospital stay : The average

length of stay in hospital was

shorter for patients in the

study group. Patients in the

study group stayed for an

average of about 3 days in the

hospital. Patients in the

control group stayed for an

average of 7 days in the

hospital. Most of these

patients were discharged

after suture removal.

However, the length of hospital

stay did not have any significant

impact on the number of post-

operative wound infections.

vRemote site infection at the

time of surgery.

vDuration of the procedure :

Most of the procedures

included in this study lasted

for about 60 minutes. Some

of the difficult procedures

were performed by senior

surgeons and this was

probably the cause for

increased incidence of post-

operative wound infection in

the study groups in the

patients operated by senior

surgeons. On an average,

time taken for a procedure by

s e n i o r s u r g e o n s w a s

considerably less than the

time taken by junior resident

surgeons.

vPre operative shaving : In our

study, we had used clippers

for pre-operative shaving

which was done just one hour

prior to surgery.

vIntensive care unit patient :

Our patients belonged to ASA

grade I, II, III and none of

them were shifted to the

intensive care unit.

vPrior antibiotic therapy :

None of our patients had

received any prior antibiotic

therapy prior to admission.

• Bac te r i a l no . , V i ru l ence ,

antimicrobial resistance.

vT ox ins , r e s i s t ance t o

Bombay Hospital Journal, Vol. 53, Special Issue, 2011 375

phagocytosis, intracellular

destruction.

vS u r f a c e c o m p o n e n t s

( c a p s u l e s ,

lipopolysaccharides)

vBacterial load more than 5 10.

• Duration of the procedure : thProlonged surgeries : > 75

percentile for that procedure.

• Preoperative shaving :

vIncreases risk by 100%.

vExtensive shaving not

needed. Removal by clippers

before procedure preferred.

vPrior antibiotic therapy :

I n c r e a s e s c h a n c e s o f

antibiotic resistance

Local wound factors

vSeroma/Haematoma

vPressure necrosis

vIncorrect sutures

vDrains

vForeign bodies

• All these factors increase the risk

of SSIs.

• Good surgical technique - best

way to avoid SSIs.

Patient factors

Co-morbidities -

TAge - Most of the wound

infections were seen in the

age group of 30-60 years.

TObesity : Obesity increased

the incidence of wound

infection in both groups.

TImmuno-suppression

TMalignancy

TDiabetes

TMalnutrition

TPeri-operative transfusions

TCigarette smoking : 2

patients from the control

group and one patient from

the study group, who had

post-operative infection,

were smokers.

TInspired oxygen fraction

TBody temperature

TGlycaemic control

• A m e r i c i a n s o c i e t y o f

anaesthesiologists - Preoperative

risk score (ASA score) based on

Co-morbidities.

An ASA score of > 2, increases risk of SSI.

• Inspired oxygen fraction : > 80% -

oxygen tension and white cell

function and decreases SSIs.

• B o d y t e m p e r a t u r e :

Normothermia reduces SSIs.

• Glucose Control : control of

glucose levels in peri-operative

period and later-up to 48 hrs

reduces SSIs.

Prevention of SSIs

Preventive measures can be :

vMicro organism related

vLocal wound related

vPatient related

Microorganism related

Primary measures that have proven

effective.

vAseptic and antiseptic

technique.

Bombay Hospital Journal, Vol. 53, Special Issue, 2011376

vP r o p e r a n t i m i c r o b i a l

prophylaxis.

vI m p l e m e n t a t i o n o f

surveillance programmes.

Aseptic and antiseptic techniques.

Environmental and architectural

character of OT

• Size

• Air management

• Equipment handling

• Traffic rules

• Operating room personnel asepsis

and clothing

Our hospital is a tertiary care centre

as well as teaching institute for

undergraduate and postgraduate

students. It is designed with a reception

area, sterile area and the operation room

(two in number). Surgical equipments are

maintained and autoclaved by trained

personnel and staff nurses. Daily cross

checking of the autoclave procedure is

done by the surgeons of the concerned

surgical unit.

Five undergraduate students are

allowed on any day and they are allowed

entry only after changing into operating

room changes and cap and masks.

Surgical site preparation

• Antiseptic preoperative showers

• Skin preparation of the surgical

site (germicidal antiseptic, incise

drapes)

• Scrubbing (1st time - 5 minutes,

consecutively 3 minutes)

• Alcoholic hand scrub solution

• Sterile drapes and gowns

• Double gloving

To be ef fective, prophylactic

antibiotics must be present in the relevant

tissues at the time the incision is made

and for the duration of the surgical 6procedure. The studies by Burke and a

recent follow-up study have shown for

preoperative antibiotics, those given 2

hours before the incision had the greatest

reduction on wound infection rates. Peri-

operative and postoperative antibiotics

were much less useful in reducing

infections than those given before 7surgery.

In most elective surgical procedures,

single dose antibiotic prophylaxis is

recommended.

3. If a procedure lasts longer than the

half-life of the prophylactic antibiotic

given, a second dose of the antibiotic

is recommended. Subsequent doses,

if necessary should be given at

intervals not longer than twice the

half-life of the drug.

4. The choice of the antibiotic should be

based on the following parameters :

TEfficacy

TSafety and adverse reactions

TEpidemio logy o f expected

pathogen

TLocal resistance pattern

TCost

A meta-analysis of 3 randomized

controlled trials (Codamos, 1999)

concluded that the use of antibiotic

prophylaxis in breast surgery resulted to

a decrease in surgical site infections from 8,9,109.5% to 5.5%. Another meta-analysis

(Platt, 1993) of 1 randomized (606

Bombay Hospital Journal, Vol. 53, Special Issue, 2011 377

Bombay Hospital Journal, Vol. 53, Special Issue, 2011

patients) and 1 large cohort (1981

patients) study showed that antibiotic

prophylaxis prevented 38% of infections,

after controlling for operation type,

duration of surgery and participation in 11the randomized trial.

A meta-analysis (Meijer et al, 1990) of

42 randomized, controlled trials involving

4129 patients was done in which patients

given antibiotics were compared with 12,13patients not given antibiotics. The

wound infection rate in the control group

was 15%, with a range of 3% to 47%.

A n t i b i o t i c p r o p h y l a x i s i s a l s o

r e c o m m e n d e d i n l a p a r o s c o p i c 14,15cholecystectomy.

Conclusion

1. Use of single dose antimicrobial is

as e f f e c t i v e as ex t ended

antimicrobial use for clean cases.

2. Local hygienic factors influence

the most during the use of single

dose antimicrobials.

3. Single dose antimicrobial is

significantly cost effective as it not

only limits the use of resources

IPD AGE SURGERY P/H/O OBESE TYPE S. NO. SURGEON F.B. CROWDIN COMPL.

Study Group

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Appendix 2

ASA score Physical state

Normal healthy patient

Patient with mild systemic disease

Pt with severe systemic disease -limits activity but not incapacitating.

Pt with incapacitating systemicdisease - constant threat to life.

Moribund patient - not expected tosurvive beyond 24 hrs.

1

2

3

4

5

Elective, not emergency, non-

traumatic, primarily closed; no acute inflammation; no break in t e c h n i q u e ; r e s p i r a t o r y , gastrointestinal, biliary and genitourinary tracts not entered.

Clean

Urgent or emergency case that isotherwise clean; elective opening of respiratory, gastrointestinal, biliary or genitourinary tract with m i n i m a l s p i l l a g e ( e . g . appendectomy) not encountering infected urine or bile; minor technique break.

Clean-contaminated

Non-purulent inflammation; grossspillage from gastrointestinal tract; entry into biliary or genitourinary tract in the presenceof infected bile or urine; majorbreak in technique; penetratingtrauma < 4 hours old; chronic open wounds to be grafted or covered

Contaminated

P u r u l e n t i n f l a m m a t i o n (e.g. abscess); preoperative perforation of respiratory,gastrointestinal, biliary or genitourinary tract; penetratingtrauma > 4 hours old.

Dirty

Appendix 1Table 1 : Classification of operative wounds based on degree of microbial contamination

Classification Criteria

378

Bombay Hospital Journal, Vol. 53, Special Issue, 2011

IPD AGE SURGERY P/H/O OBESE TYPE S. NO. SURGEON F.B. CROWDIN COMPL.

Study Group

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but also decreases the overall

hospital stay.

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