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Original Article

Protocol for Developing a Surveillance System for Surgical Site


Infections
Purva Mathur, Samarth Mittal1, Vivek Trikha1, Ayush Lohiya, Surbhi Khurana, Sonal Katyal, Nidhi Bhardwaj, Sushma Sagar2, Subodh Kumar2,
Rajesh Malhotra1, Kamini Walia3
Departments of Laboratory Medicine and 1Orthopedics, Jai Prakash Narayan Apex Trauma Center, All India Institute of Medical Sciences,
2
Division of Trauma Surgery, Jai Prakash Narayan Apex Trauma Center, All India Institute of Medical Sciences, 3Epidemiology and Communicable Diseases,
Indian Council of Medical Research, New Delhi, India

Abstract
Purpose: Healthcare-associated infections (HCAIs/ HAIs) are the most common adverse occurrences during health care delivery. Across the
globe, millions of patients are affected by HAIs annually, with a higher burden and impact in developing nations. a major lacuna in planning
preventing protocols is the absence of National Surveillance Systems in most low-middle income countries, which also prevents allocation
of resources to the high-priority areas. Among all the HAIs, there is a huge global burden of SSIs, in terms of morbidity, prolonged hospital
stays, increased antimicrobial treatment as well as attributable mortality. Method: This manuscript details the process of establishment of an
SSI surveillance protocol at a level-1 trauma centre in North India. Result and Conclusion: Surveillance is an essential tool to reduce this
burden. It is also an important primary step in recognizing problems and priorities, and it plays a crucial role in identifying risk factors for SSI
and to be able to target modifiable risk factors. Therefore, it is imperative to establish reliable systems for surveillance of HAIs, to regularly
estimate the actual burden of HAIs, and to use these data for developing indigenous preventive measures, tailored to the country’s priorities.

Keywords: Healthcare‑associated infections, India, surgical site infections, surveillance

Introduction to 17.8%, depending primarily on the type of surgeries. A WHO


survey found that in LMICs, the incidence of SSI ranged from
Healthcare‑associated infections  (HCAIs/HAIs) are the most
1.2 to 23.6/100 surgical procedures. This contrasted with rates
frequent adverse events during health‑care delivery. Millions
between 1.2% and 5.2% in high‑income countries. Table 1 gives
of patients are affected by HAIs every year worldwide; the
a brief overview of the SSI rates in developed nations.[4,9‑15]
burden and impact of these infections being greater in low‑ and
middle‑income countries  (LMICs). Hospital‑wide prevalence
of HAI varies from 5.7% to 19.1%, with a pooled prevalence of Burden of Surgical Site Infections in Low‑ and
10.1%. Among the HAIs, surgical site infections (SSIs) are one Middle‑Income Countries
of the most common, morbid and costly to treat. Worldwide,
The burden of SSIs in these countries is much higher than the
approximately 187–281 million surgical procedures are performed
each year. SSIs are one of the undesirable and serious outcomes of
surgeries; despite the high burden, most SSIs are preventable.[1‑8] Address for correspondence: Dr. Purva Mathur,
The global burden of SSIs is huge, in terms of morbidity, Department of Laboratory Medicine, Jai Prakash Narayan Apex Trauma
Centre, All India Institute of Medical Sciences, New Delhi ‑ 110 029, India.
repeat surgeries, prolonged hospitalisation, increased length of E‑mail: [email protected]
antimicrobial treatment and attributable mortality (0.4%–0.8% of
SSIs resulting in death). Large‑scale studies done in the developed Received : 21‑11‑2019 Revised : 29-11-2019
countries as part of national surveillance systems or networks or Accepted : 03-12-2019 Published Online : 29-01-2020
multi‑hospital surveys have reported SSI rates varying from 0.9%
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DOI: How to cite this article: Mathur P, Mittal S, Trikha V, Lohiya A, Khurana S,
10.4103/ijmm.IJMM_19_446 Katyal S, et al. Protocol for developing a surveillance system for surgical
site infections. Indian J Med Microbiol 2019;37:318-25.

318 © 2020 Indian Journal of Medical Microbiology | Published by Wolters Kluwer - Medknow
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Mathur, et al.: SOP for SSI

Table 1: Burden of surgical site infections in developed nations


Country and year Type of surveillance network/ Rate of Estimated additional cost of treatment/other
of study number of hospitals SSI (%) implications due to SSI in the country
USA, 2014[10‑11] NHSN 0.86 US $3.5 billion-10 billion
3654 hospitals Additional LOS 9.7 days per SSI
European countries, European CDC 0.75-9.5 1.4-19.1 billion euros
2010-2011[12‑13] Additional LOS 6.5 days, with three times increased
cost of treatment of infected patients
Australia, 2002-2013[14] National HAI surveillance network 2.8
Japan, 2013[4,15] National Nosocomial Infection 15 (GI Additional $8791 per SSI case. Additional LOS
Surveillance system surgery) 20.7 days, may extend to 48.9 days in cardiac surgeries
Singapore, 2008 Tertiary care hospital study 8.3
SSI: Surgical site infection, NHSN: National Healthcare Safety Network, CDC: Centers for Disease Control and Prevention, HAI: Healthcare‑associated
infection, LOS: Length of stay, GI: Gastro-intestinal

developed countries. In the 2011 WHO report on the global Evaluation of the key determinants of SSIs (or risk factors) is
burden of HAI from LMICs, SSI was the most frequent also an essential step to identify strategies and measures for
HAIs reported hospital‑wide, with the level of risk being improvement.
much higher than in developed countries. In this report, the
Surveillance of SSIs is very different from other HAIs such as
pooled SSI incidence in LMICs and developed countries
ventilator‑associated pneumonia (VAP), central line‑associated
were, respectively, 11.8 and 5.6/100 surgical procedures.
bloodstream infections  (CLABSIs) and catheter‑associated
The rates of SSIs have ranged from 2.1 in the Republic of
urinary tract infections (CAUTIs). The primary difference being
Korea to 2.5%–15.4% in Uruguay, and 1.9%–3.1% in Chile.
The overall prevalence of SSI in Africa/Middle East, Latin that surveillance for VAP, CLABSI and CAUTI are truncated at
America, Asia and China was reported to be 10%, 7%, 4% the time of discharge from the unit/hospital. In contrast, most
and 4%, respectively. In a review published in 2019 by Couto SSIs develop after the patient is discharged from the hospital,
et al., the overall prevalence of SSI in developing countries in considering the ever‑shortening in‑hospital stay after surgeries.
elective clean and clean‑contaminated surgeries was estimated Some SSIs may develop as long as 3 months or even a year after
to be 6%, increasing to 15% when studies only focusing on the surgery. SSI surveillance, therefore, requires a very prolonged
post‑discharge surveillance were included.[4,10‑16] follow‑up, a lot more engagement by the patients and health‑care
workers, and therefore, not feasible in many LMICs.[17‑19,37,38]
Surveillance for Surgical Site Infections Surveillance is an essential tool to reduce its burden. It is also
In most countries, the burden of HAIs is grossly underestimated an important first step in identifying problems and priorities;
for want of proper surveillance and reporting systems. and it plays an important role in recognising risk factors for
Estimation of the national burden of HAIs is a prerequisite SSI thus, helping to target modifiable risk factors.
for planning infection control policies. Robust evidence Carefully obtained surveillance data can identify needed
emphasises the fact that HAI can be prevented, and the burden infection prevention and control (IPC) interventions and areas
is reduced by as much as 50%.[17‑20] of opportunity for improvements in care. The surveillance data
Surveillance is defined as “the ongoing, systematic collection, can also help assess the quality of infection prevention efforts.
analysis and interpretation of health data essential to the planning, Both process measures (for example, the implementation of
implementation and evaluation of public health practice, closely preventive measures) and outcome measures (SSI rates) should
integrated with the timely dissemination of these data to those be measured through surveillance so that IPC measures can be
who need to know.” Surveillance of SSI is part of the WHO safe implemented, and performance improved. The application of
surgery guidelines. Many countries have introduced mandatory standardised definitions is one of the minimum requirements
surveillance of SSI, such as the UK and certain states in the USA, for data comparisons at local, national and international levels.
whereas other countries have voluntary‑based surveillance, such The use of standardised definitions is crucial to the reliability
as France, Germany and Switzerland.[21‑36] of SSI surveillance for the following reasons:
• It allows establishing that the infection was acquired
There is a lack of national surveillance systems in most LMIC,
during the hospital stay
which is a major lacuna in planning preventing protocols and
• To ensure that it is a true infection and not colonisation
allocating resources to the highpriority areas. Therefore, there
• Allows for inter‑hospital comparisons and benchmarking.
is an urgent need:
• To establish reliable systems for HAI surveillance The National Healthcare Safety Network (NHSN) provides the
• To gather data on the actual burden of HAIs regularly most reliable and updated definitions.[1,39,40] At the All India Institute
• To use this data for developing indigenous preventive of Medical Sciences, New Delhi, we have initiated a multi‑centric
measures, tailored to the country’s priorities. study, supported by ICMR, where 90‑day post‑discharge

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Mathur, et al.: SOP for SSI

surveillance is being conducted to ascertain the actual prevalence Outcome measures


of SSI in a select group of surgeries. This manuscript describes Monitoring/surveillance for surgical site infection
the process of the establishment of an SSI surveillance protocol. For surveillance purposes, SSIs are divided into categories
Objectives of a surveillance program involving only skin and subcutaneous tissue  (superficial
incisional SSIs), those involving deeper soft tissues of the
• Collection of data on SSI rates to ascertain the magnitude
incision (deep incisional SSIs), and those involving any part
of the problem
of the deep anatomy (organ space SSIs), such as a joint space.
• Analysis of the data to identify and investigate trends
The definitions for SSIs have been adopted from the Centres
• Ascertain the most common pathogens and their
for Disease Control and Prevention NHSN system.[50‑52] Table 2
susceptibility patterns
details the classification of SSI.
• Identify the risk factors in the Indian set‑up
• Interpretation of analysed data at regular intervals to We have developed a website for SSI surveillance, where
provide feedback the SOP is available. Definitions of SSI surveillance, wound
• Data‑driven improvement actions classification and the details of surveillance methodology
• Evaluation of preventive interventions can be accessed at http://ssi.haisindia.com. Figure 1 shows a
• The following are the essential prerequisites for screenshot of the home page of the website.
developing a surveillance system for SSIs[1,41-43] Case finding
• An standard operating procedure (SOP) with objectives, This requires active, patient‑based, prospective surveillance.
methodology and all elements of the surveillance process Both in‑hospital and post‑discharge surveillance methods
• Adequate human resources for surveillance  (infection should be used to detect SSIs. Review methods may include
control nurses and epidemiologists) one or more of the following:[50‑52]
• Training of all surveillance staff (induction and at regular • Direct inspection of the wound
intervals) • Medical records/surgical/OT notes/physician’s notes/
• Consistent application of definitions and common admission, readmission, ED notes
methodology • Laboratory/X‑ray, other diagnostic test reports
• IT/Informatic services (to design an interpret reports) • Information from the patients and families
• Data quality/evaluation methods • Surveys by mail or telephone.
• Development of a feedback mechanism
• Use surveillance findings in developing/implementing Role of the  Hospital Infection Control Nurses (HICNs)
preventive activities (HICNs)/infection preventionists/epidemiologist/information
• Each hospital to use its data for internal benchmarking technology departments (if available)
and setting targets. • To lead the development of the SSI surveillance plan
• To perform the surveillance using established, approved,
The SSI surveillance programme should measure both
and consistent surveillance criteria or definitions
infection rates and compliance rates with surgical infection
• Analyse and present the data to all stakeholders.
prevention processes.
Data collection
Process and Outcome Measures Collect SSI  (numerator) and operative procedure category
(denominator) data on all procedures included in the selected
SSI surveillance should include measures of processes to
procedure categories for at least 1  month. The numerator
indicate whether caregivers are adhering to best practices and
and denominator data forms are available on the website
established policies as well as the outcomes of care during
the pre‑operative, intra‑operative and post‑operative phases.
Process measures
In the pre‑operative phase, hand hygiene, accurate assessment
of patient status and risk factors, and initiating specific
procedures such as maintaining normothermia, are some of
the IPC processes. In the intra‑operative stage, IPC processes
include skin antisepsis, maintaining normothermia and glucose
monitoring. Postoperatively, aseptic wound care is a primary
prevention process.[44‑49]
Calculation of compliance
All calculations can be performed by using the formula of:
The number of events (numerator) divided by the number of
persons at risk or number of expected processes. Figure 1: Home page of surgical site infection web page

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Mathur, et al.: SOP for SSI

Table 2: Classification of surgical site infections


Superficial incisional SSI
This is based on the following criteria:
DOE for infection occurs within 30 days after a surgical procedure (where day 1 = the procedure date) and involves only skin and subcutaneous tissue of
the incision and patient has at least one of the followings:
a. Purulent drainage from the superficial incision
b. Organisms identified from an aseptically‑obtained specimen from the superficial incision or subcutaneous tissue by a culture
c. Superficial incision that is deliberately opened by a surgeon and patient has at least one of the following signs or symptoms: Pain or tenderness;
localised swelling; erythema or heat
d. Diagnosis of a superficial incisional SSI by the surgeon/attending physician
There are two specific types of superficial incisional SSIs:
1. SIP ‑ A superficial incisional SSI that is identified in the primary incision in a patient that has had an operation with one or more incisions
2. SIS ‑ A superficial incisional SSI that is identified in the secondary incision in a patient that has had an operation with more than one incision
Deep incisional SSI
This is based on the following criteria:
The DOE for infection occurs within 30 or 90 days after the operative procedure (where day 1 = the procedure date) and
Involves deep soft tissues of the incision (for example, fascial and muscle layers) and patient has at least one of the following:
a. Purulent drainage from the deep incision
b. A deep incision that spontaneously dehisces, or is deliberately opened/aspirated by a surgeon/attending physician and organism is identified by
culture and patient has at least one of the following signs or symptoms: Fever (>38°C); localised pain or tenderness. A culture‑based test that has a
negative finding does not meet this criterion
There are two specific types of deep incisional SSIs:
1. DIP ‑ A deep incisional SSI that is identified in a primary incision in a patient that has had an operation with one or more incisions
2. DIS ‑ A deep incisional SSI that is identified in the secondary incision in a patient that has had an operation with more than one incision
Organ/space SSI
This is based on the following criteria:
DOE for infection occurs within 30 or 90 days after the operative procedure and infection involves any part of the body deeper than the fascial/muscle
layers, that is opened or manipulated during the operative procedure and patient has at least one of the following:
a. Purulent drainage from a drain that is placed into the organ/space
b. Organisms are identified from fluid or tissue in the organ/space by a culture‑based test
SSIs: Surgical site infections, SIP: Superficial incisional primary, SIS: Superficial incisional secondary, DIP: Deep incisional primary, DIS: Deep incisional
secondary, DOE: Date of event

http://ssi.haisindia.com. The surgical procedure must meet of a rate based on the date of procedure, not the date of the
the definition of an operative procedure to be included event.[50‑52] Figures  2 and 3 show the SSI surveillance case
in the surveillance. All procedures should be followed report form and denominator form, respectively. The forms
for superficial, deep and organ/space SSIs. All patients can be accessed at the website http://ssi.haisindia.com.
undergoing the defined surgeries (for which a hospital intends Additional terms
to undertake SSI surveillance) need to be monitored for SSI. 1. Date of event (DOE): For an SSI, the DOE is the date when
SSI form should be completed for each SSI. The SSI form the first element used to meet the SSI infection criterion
includes patient demographic information and information occurs for the first time during the SSI surveillance
about the operative procedure, including the date and type period. The date of the event must fall within the SSI
of procedure. Information about the SSI includes the date of surveillance period to meet SSI criteria. The type of
SSI, specific criteria met for identifying the SSI when/how SSI (superficial incisional, deep incisional or organ/space)
the SSI was detected, whether the patient developed a reported should reflect the deepest tissue layer involved
secondary bloodstream infection, whether the patient died, in the infection during the surveillance period. The date
the organism(s) identified and the organisms’ antimicrobial of the event should be the date that the patient met the
susceptibilities.[50‑52] criteria for the deepest level of infection
2. Duration of operative procedure: The interval in hours
and minutes between the procedure/surgery start time
Calculation of Surgical Site Infection Rates (PST), and the procedure/surgery finish  (PF) time, as
The most common outcome indicator is the SSI rate. For any defined by the Association of Anaesthesia Clinical
given period, denominator data represent the total number of Directors
procedures within each category. Numerator data will be the • PST: Time when the procedure is begun (e.g., incision for
number of SSIs in that same period. SSI rates per 100 operative a surgical procedure)
procedures are calculated by dividing the number of SSIs by • PF: Time, when all instrument and sponge counts are
the number of specific operative procedures and multiplying completed and verified as correct, all post‑operative
the results by 100. SSIs should be included in the numerator radiologic studies to be done in the  Operating room

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Mathur, et al.: SOP for SSI

Figure 2: Surgical site infection surveillance case report form (Complete form can be accessed at http://ssi.haisindia.com)

(OR), are completed, all dressings and drains are performed on a patient whose date of admission to the
secured, and the physicians/surgeons have completed all HCF, and date of discharge are the same calendar day
procedure‑related activities on the patient 6. Non‑primary Closure: Closure of the surgical wound
3. Emergency operative procedure: A  procedure that in a way which leaves the skin level completely open
is documented as per the hospital’s protocol to be an following the surgery. Closure of any portion of the
emergency or urgent procedure skin represents primary closure. For surgeries with
4. Inpatient operative procedure: An operative procedure non‑primary closure, the deep tissue layers may be closed
performed on a patient whose date of admission to by some means (with the skin level left open), or the deep
the Healthcare facility (HCF), and the date of discharge and superficial layers may both be left completely open.
are different calendar days Wounds with non‑primary closure may or may not be
5. Outpatient operative procedure: An operative procedure described as ‘packed’ with gauze or other material, and

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Mathur, et al.: SOP for SSI

Figure 3: Surgical site infection surveillance denominator form (Complete form can be accessed at http://ssi.haisindia.com)

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