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Clinical practice guideline for
Surgical site infection: prevention and treatment
of surgical site infection
April 2006
Draft full guideline for consultation
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National Collaborating Centre for Nursing and Supportive Care
This work was undertaken by the National Collaborating Centre for Nursing and Supportive Care
(NCC-NSC) and the Guideline Development Group (GDG) formed to develop this guideline on behalf
of the National Institute for Health and Clinical Excellence. Funding was received from the National
Institute for Health and Clinical Excellence. The NCC-NSC consists of a partnership between: the
Centre for Evidence-Based Nursing (University of York), the Clinical Effectiveness Forum for Allied
Health Professionals, the Healthcare Libraries (University of Oxford), the Health Economics Research
Centre (University of Oxford), the Royal College of Nursing and the UK Cochrane Centre.
Disclaimer
As with any clinical guideline, recommendations may not be appropriate for use in all
circumstances. A limitation of a guideline is that it simplifies clinical decision-making (Shiffman
1997). Decisions to adopt any particular recommendations must be made by the practitioners
in the light of:
Available resources
Local services, policies and protocols
The patients circumstances and wishes
Available personnel and devices
Clinical experience of the practitioner
Knowledge of more recent research findings.
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Contents 1
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Disclaimer........................................................................................................ 2
Guideline Development Group membership and acknowledgements ............. 5
Terminology..................................................................................................... 7
Abbreviations................................................................................................... 8
1 EXECUTIVE SUMMARY .................................................................... 15
2 PRINCIPLES OF PRACTICE AND SUMMARY OF GUIDELINE
RECOMMENDATIONS....................................................................... 17
2.1.1 Person-centred care ............................................................................. 17
2.1.2 A collaborative inter-disciplinary approach to care................................ 17
2.1.3 Organisational issues.......................................................................... 18
Preoperative phase........................................................................................ 19
Intraoperative phase...................................................................................... 19
Postoperative phase...................................................................................... 22
3.1 Clinical need for the guideline ............................................................. 24
3.2 Definition of SSI .................................................................................. 24
4 AIMS OF THE GUIDELINE................................................................. 27
4.1 Who the guideline is for....................................................................... 27
4.2 Groups covered by the guideline......................................................... 27
4.3 Groups not covered............................................................................. 27
4.4 Healthcare setting ............................................................................... 27
4.5 Interventions covered.......................................................................... 28
4.5.1 Preoperative....................................................................................... 28
4.5.2. Intraoperative...................................................................................... 28
4.5.3. Postoperative Phase (prevention and treatment) ................................ 28
4.6 Interventions not covered.................................................................... 28
4.7 Guideline Development Group............................................................ 29
5.1 Summary of development process...................................................... 30
5.2 Clinical effectiveness review methods................................................. 31
5.3 Cost effectiveness review methods..................................................... 36
5.4 Submission of evidence ...................................................................... 39
5.5 Evidence synthesis and grading.......................................................... 40
5.6 Formulating and grading recommendations........................................ 43
6.1 Preoperative Showering...................................................................... 46
6.2 Preoperative hair removal ................................................................... 51
6.3 Mechanical bowel preparation for elective colorectal surgery............. 67
6.4 (a) Hand decontamination ....................................................................... 72
6.4 (b) Removal of Nail Polish and Finger rings ............................................ 74
6.5 Non-sterile Theatre wear..................................................................... 76
6.6 Surgical Scrubbing.............................................................................. 78
6.7 Sterile Theatre Wear ........................................................................... 83
6.8 Double Gloving.................................................................................... 89
6.9 Face masks......................................................................................... 99
6.10 Preoperative skin antiseptics for preventing surgical wound infection104
6.11 Drapes .............................................................................................. 120
6.12 Perioperative Warming...................................................................... 130
6.13 Perioperative Oxygen....................................................................... 136
6.14 Intra-cavity solutions ......................................................................... 141
6.15 Intra operative skin antiseptics.......................................................... 145
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6.16 Drains for the prevention of surgical site infection............................. 150 1
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6.17 Closure Methods and Materials......................................................... 151
6.18 Wound dressings for surgical sites.................................................... 199
6.19 Clean versus sterile techniques ........................................................ 221
6.20 Postoperative wound cleansing ........................................................ 225
6.21 Dressings and topical agents for surgical wounds healing by secondary
intention Part I ................................................................................... 230
6.22 Dressings and Topical Agents for Surgical Wounds Healing By Secondary
Intention Part II: Toenail Avulsion...................................................... 250
6.23 Pinsite Care ...................................................................................... 256
Methodological quality of included studies................................................... 257
6.24. Treatments for people with surgical site infections ............................. 262
6.25 Patients information needs, experiences, and quality of life issues. 271
Results......................................................................................................... 272
7 RECOMMENDATIONS FOR RESEARCH ....................................... 277
8 Prevention & Management of Surgical Site Infection (SSI) Algorithm279
9 AUDIT CRITERIA.............................................................................. 280
10 DISSEMINATION OF GUIDELINES................................................. 283
11 VALIDATION..................................................................................... 283
12 SCHEDULED REVIEW OF GUIDELINE........................................... 283
13 References........................................................................................ 284
Appendices AG are in separate files.
Part B of the Full Guideline: Separate Appendices
Appendix A: Guideline development Group
Appendix B: Registered Stakeholders
Appendix C: Search Strategies and Searched Data Bases
Appendix D: Tables of Included Studies
Appendix E: Quality Assessment of Studies
Appendix F: Tables of Excluded Studies
Appendix G: Quality Checklists for Economic Studies
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Guideline Development Group membership and acknowledgements 1
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Ms Una Adderley
Tissue Viability Prescribing Specialist Nurse, Malton Hospital, Malton North Yorkshire
Dr Ian Bullock
Director, NCC-NSC
Mr Mark Collier
Lead Nurse/Consultant - Tissue Viability, Pilgrim Hospital, Boston, Lincolnshire
Professor Christopher Dowson
Professor of Microbiology, University of Warwick
Mrs Elizabeth Gibbs
Carer Representative
Mr Chris Jay
Principal Pharmacist Medicines Management, Russell's Hall Hospital Dudley
Mrs Kathryn Kitson
Team Leader - Orthopaedics & Trauma, Bradford Royal Infirmary
Mr Ramon Luengo-Fernandez
Health Economist, Health Economics Research Centre, University of Oxford
Dr Miles Maylor
Consultant Nurse - Tissue Viability, John Radcliffe Hospital, Oxford
Mr Peter Moore
Consultant General Surgeon, Scunthorpe General Hospital
Ms Lakshmi Murthy
Research and Development Fellow, NCC-NSC
Dr Carole Rawlinson
Carer Representative
Dr Eileen Scott
Research Fellow, Centre for Clinical Management Development, University of Durham
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Mr Rick Turnock
Consultant Paediatric Surgeon, Royal Liverpool Children's Hospital
Dr Maggie Westby
Senior Research and Development Fellow, NCC-NSC
Dr Paul Yerrell
Senior Research Fellow, School of Health & Social Care, Oxford Brookes University
Staff at the NCC-NSC who contributed to this guideline:
Ms Jackie Chandler
Research Assistant (to November 2004)
Mr Martin Dougherty
Director (from November 2004 to July 2005)
Ms Elizabeth Gibbons
Research and Development Fellow (to August 2005)
Ms Jenny Gordon
Research and Development Fellow
Ms Elizabeth McInnes
Senior Research and Development Fellow (to October 2005)
Mr Paul Miller
Information Specialist
Ms Emma Nawrocki
Administrator
Mr Edward Weir
Centre Manager
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The NCC-NSC would also like to thank the following people for their assistance
with the guideline:
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Ms Rosa Legood
Health Economist, Health Economics Research Centre, University of Oxford
Dr Jacoby Patterson, Dr Iveta Simera, Dr Lesley Smith
for assistance with systematic reviewing
Terminology
1. Where the term carer is used, this refers to unpaid carers as opposed to paid carers (eg.
careworkers).
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Abbreviations 1
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Technical terms
ARR absolute relative risk
CI confidence intervals
GDG Guideline Development Group
HTA health technology assessment
NNT number needed to treat
RCT randomised controlled trial
RR relative risk
Organizations
DoH Department of Health
MHRA Medicines and Healthcare Products Regulatory Agency (formerly Medical Devices
Agency)
NCC-NSC National Collaborating Centre for Nursing and Supportive Care
NICE National Institute for Health and Clinical Excellence
RCN Royal College of Nursing
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General Glossary 1
2 (partially based on Clinical epidemiology glossary by the Evidence Based Medicine Working
Group, www.ed.ualberta.ca/ebm; Information for national collaborating centres and guideline
development groups, (NICE 2001).
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Absolute risk reduction: The difference between the observed event rates (proportions of
individuals with the outcome of interest) in the 2 groups.
Bias: May result from flaws in the design of a study or in the analysis of results and may result in
either an underestimate or an overestimate of the effect.
Case-control study: A study in which the amount of exposure to a potentially causative factor in a
group of patients (cases) who have a particular condition is compared with the exposure in a similar
group of people who do not have the clinical condition (the latter is called the control group)
Clinical effectiveness: The extent to which an intervention (for example, a device or treatment)
produces health benefits (i.e. more good than harm)
Cochrane Collaboration: an international organisation in which people retrieve, appraise and review
available evidence of the effect of interventions in health care. The Cochrane Database of Systematic
Reviews contains regularly updated reviews on a variety of issues. The Cochrane library contains the
Central Register of Controlled Trials (CENTRAL) and a number of other databases which are regularly
updated and is available as CD-Rom or on the internet (www.cochranelibrary.com)
Cohort study: Follow-up of exposed and non-exposed groups of patients (the 'exposure' is either a
treatment or condition), with a comparison of outcomes during the time followed-up
Co-interventions: Interventions/treatments etc other than the treatment under study that are applied
to the treatment and/or control groups
Co-morbidity: Co-existence of a disease or diseases in a study population in addition to the condition
that is the subject of study
Confidence interval (CI): The range of numerical values within which we can be confident that the
population value being estimated is found. Confidence intervals indicate the strength of evidence;
where confidence intervals are wide they indicate less precise estimates of effects
Cost-benefit analysis: A type of economic evaluation, which estimates the net benefit to society of an
intervention as the incremental (difference in) benefit of the intervention minus the incremental
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(difference in) cost, with all benefits and costs measured in monetary units. If benefits exceed costs,
the evaluation would be a basis for recommending the intervention.
Cost-consequences analysis: A type of economic evaluation, whereby both outcomes and costs of
alternative interventions are described, without any attempt to combine the results.
Cost effectiveness: the cost per unit of benefit of an intervention. In cost effectiveness analysis, the
outcomes of different interventions are converted into health gains for which a cost can be associated.
Cost-of-illness/economic burden studies: An analysis of the total costs incurred by a society due to
a specific disease.
Cost impact: The total cost to the person, the NHS or to society
Cost-minimisation analysis: A type of economic evaluation used to compare the difference in costs
between programs that have the same health outcome.
Costing study: The simplest form of economic study, measuring only the costs of given interventions.
Cost-utility analysis: A type of economic evaluation in which costs and effects of an intervention and
at least one alternative are calculated and presented in a ratio of incremental (difference in) cost over
incremental (difference in) effect. Effects are utility units (e.g. QALYs).
Discounting: the process of converting future pounds and future health outcomes to their present
value
Economic evaluation: comparative analysis of alternative courses of action in terms of both their
costs and consequences
Effectiveness: The extent to which interventions achieve health improvements in real practice
settings
Efficacy: The extent to which medical interventions achieve health improvements under ideal
circumstances
Epidemiological study: A study which looks at how a disease or clinical condition is distributed
across populations, e.g. across geographical areas or over time, or between age groups
Extrinsic: Factors that are external to the individual
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Follow-up: Observation over a period of time of an individual, group or population whose relevant
characteristics have been assessed in order to observe changes in health status or health-related
variables
Gold standard: A method, procedure or measurement that is widely accepted as being the best
available, to which a new method is compared
Health professional: Includes nurses, allied health professionals and doctors.
Health technology assessment: The process by which evidence on the clinical effectiveness and the
costs and benefits of using a technology in clinical practice is systematically evaluated
Incidence: The number of new cases of illness commencing, or of persons falling ill during a
specified time period in a given population
Intrinsic: Factors present within the individual
Logistic regression model: A data analysis technique to derive an equation to predict the probability
of an event given one or more predictor variables. This model assumes that the natural logarithm of
the odds for the event (the logit) is a linear sum of weighted values of the predictor variable. The
weights are derived from data using the method of maximum likelihood
Meta-analysis: A statistical method of summarising the results from a group of similar studies
Number needed to treat: The number of patients who need to be treated to prevent one event.
Odds ratio: Odds (chance) of being exposed in subjects with the target disorder divided by the odds
of being exposed in control subjects (without the target disorder).
Predictive validity: a risk assessment tool would have high predictive validity if the predictions it
makes (say, of pressure ulcer development in a sample) became true (i.e. it has both high sensitivity
and specificity)
Prevalence: The proportion of persons with a particular disease within a given population at a given
time
Quality adjusted life expectancy: Life expectancy using quality adjusted life years rather than
nominal life years (i.e. taking into account not only how long someone lives, but their health state or
level of disability during that time)
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Quality adjusted life years (QALYs): A measure of health outcome which assigns to each time
period a weight, ranging from 0-1, corresponding to the health-related quality of life during that period,
where a weight of 1 corresponds to optimal health, and a weight of 0 corresponds to a health state
judged as equivalent to death: these are then aggregated across time periods
Randomised controlled trial (RCT): A clinical trial in which the treatments are randomly assigned to
subjects. The random allocation eliminates bias in the assignment of treatment to patients and
establishes the basis for the statistical analysis
Relative risk: An estimate of the magnitude of an association between exposure and disease which
also indicates the likelihood of developing the disease among persons who are exposed relative to
those who are not. It is defined as the ratio of incidence of disease in the exposed group divided by
the corresponding incidence in the non-exposed group
Retrospective cohort study: A study in which a defined group of persons with an exposure that
occurred in the past and an appropriate comparison group who were not exposed are identified at a
time later than when they were exposed and followed from the time of exposure to the present, and in
which the incidence of disease (or mortality) for the exposed and unexposed are assessed
Sensitivity: percentage of those who developed a condition who were predicted to be at risk
Specificity: percentage of those correctly predicted not to be at risk
Systematic review: A way of finding, assessing and using evidence from studies (usually RCTs) to
obtain a reliable overview
User: Any one using the guideline
Validity: The extent to which a variable or intervention measures what it is supposed to measure or
accomplish
Internal validity: of a study refers to the integrity of the design
External validity: of a study refers to the appropriateness by which its results can be applied to non-
study patients or populations
Glossary (specific to the guideline):
Antibiotic formulary local policy document produced by the interprofessional team combining best
evidence and clinical judgement
Burst abdomen wound dehiscence of an abdominal incision
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Colony Forming Units (CFUs)- a measure of viable bacterial numbers
Cosmesis: The aesthetic result of a procedure
Erythema: Redness of the skin
Healing by primary intention: The surgeon has closed the wound (e.g. with sutures) so that the skin
will heal up straight away
Healing by secondary intention: The surgeon has left the wound open so that deeper layers heal
before the skin this may be helpful where there is a risk of infection with anaerobic organisms (ones
that survive in an atmosphere without oxygen) as the wound will be exposed to more oxygen and
anaerobic organisms will be discouraged
Infectious extra-abdominal complication: postoperative infectious complication at extra-abdominal
site
Modern Interactive Dressing: Dressings that aim to create the optimum wound healing environment
eg. hydrocolloids, hydrogels, foams, films, alginates and soft silicones
Peritonitis: presence of postoperative infections at the abdominal cavity, localized (abscess)
Wound infection: the presence of pathogenic organisms in a wound giving rise to symptoms, e.g.
fever, purulent discharge
Oedema: Swelling of a tissue due to the accumulation of fluid
Sharp debridement: Small quantities of tissue lying just above the level of viable tissues can be
removed by a clinician in the ward or home environment.
Surgical debridement: The excision or wide resection of all dead or damaged tissues can be carried
out by a clinician in theatre with local or general anaesthetic
Surgical site infection (SSI): A postoperative complication occurring within 30 days following a
surgical procedure. A SSI can occur when bacteria from the skin, other parts of the body or the
environment enter the incision made by the surgeon and multiply in the tissues. This results in physical
symptoms as the body tries to fight the infection. There may be pus, inflammation, swelling, pain and
fever.
Classification of infection is determined by the depth of invasion of micro-organisms. Such
classification is described as:
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Superficial incisional, affecting the skin and subcutaneous tissue.
Deep incisional, affecting the facial and muscle layers.
Organ or space infection affecting any part of the anatomy opened or manipulated during the
operation
A surgical site infection can include wound infection or dehiscence and can be defined as pus, or a
swab with >10 e6 colony forming units (cfu) per mm tissue and at least one of the following signs or
symptoms: pain, localised swelling, redness or heat.
Surgical procedure: A therapeutic procedure involving an incision with instruments
Surgical wound classification:
Clean: An uninfected operative wound in which no inflammation is encountered and in which the
respiratory tract, alimentary, genital, or uninfected urinary tracts are not entered.
Clean-contaminated: Operative wounds in which the respiratory, alimentary, genital, or urinary tract
is entered under controlled conditions and without unusual contamination.
Contaminated: Open, fresh, or accidental wounds; operations with major breaks in sterile technique
or gross spillage from the gastrointestinal tract; and incisions in which acute, non-purulent
inflammation is encountered.
Dirty or infected: Old traumatic wounds with retained devitalised tissue, and those that involve
existing clinical infection.
(National Academy of Science 1964)
Wound dehiscence: Separation of the edges of a wound at a time when the wound would be
expected to be healing
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1 EXECUTIVE SUMMARY
The National Institute for Health and Clinical Excellence (NICE or the Institute)
commissioned the National Collaborating Centre for Nursing and Supportive Care (NCC-NSC)
to develop guidelines on surgical site infection (SSI). This follows referral of the topic by the
Department of Health and Welsh Assembly Government. This document describes the
methods for developing the guidelines and presents the resulting recommendations. It is the
source document for the NICE (abbreviated version for health professionals) and Information
for the Public (patient) versions of the guidelines which will be published by NICE. The
guidelines were produced by a multidisciplinary guideline development group and the
development process was undertaken by the NCC-NSC.
The main areas examined by the guideline were during the:
Preoperative phase
Intraoperative phase
Postoperative phase
This guideline covers areas relevant to the prevention and management of surgical site
infections reflecting the complete patient journey, from preoperative showering to methods of
wound closure to subsequent wound management. The guideline incorporates eight Cochrane
reviews, one Health Technology Assessment report and one Joanna Briggs Institute
systematic review. A total of 1014 studies were assessed, with 178 selected for review. This
involved a total of 58 thousand patients. There were 32 additional health economic studies
included. Recommendations are based on the quality of clinical and cost effectiveness
evidence available. Good practice points are also made based on a combination of evidence
(low grade) and expert opinion that reflects contemporary thinking. The care pathway reflects
a logical sequencing to what is, in effect, tracking the progress of the patient from admission
through to rehabilitation after surgery. This sequencing has enabled the Guideline
Development Group (GDG), supported by the technical team, to look at the evidence reviews,
understand the clinical context and consider the patient voice when shaping guidance to
minimise the risk of acquired infection. Patient experience is at the heart of development, this
representation provides invaluable input to the GDG. Evidence published after January 2006
was not considered.
Healthcare professionals should use their clinical judgement and consult with patients when
applying the recommendations. Recommendations aim to reduce variations in practice, thus
improving patient outcomes related to both the prevention and management of surgical site
infection. This guidance is intended to be the source document for NHS Trust local policy
development. Its success is dependent on the healthcare team owning the challenge of
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reducing SSI. This is centres around the team recognising their part in reducing the incidence
of SSI, minimising patient risk from associated infection, and lowering the actual cost of care to
the NHS. Similar to the associated guideline produced by the Scottish Intercollegiate Guideline
Network on Antibiotic Prophylaxis in Surgery in 1999, the guideline is not intended to provide
every surgical speciality with a comprehensive text on prevention of SSIs, but rather to state
clearly what the evidence is and how this should be interpreted in shaping contemporary
practice. The algorithm (see section 8) enables healthcare professionals, patients and carers
to visualise the care pathway and the application of evidence and good practice points in
determining reduced incidence of SSIs.
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Versions for healthcare professionals (NICE version) and for patients and carers (Information
for the Public) are also available.
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2 PRINCIPLES OF PRACTICE AND SUMMARY OF GUIDELINE
RECOMMENDATIONS
2.1 Principles of practice
The principles, outlined below, describe the ideal context in which to implement the
recommendations contained in this guideline. They reflect original research and development
work previously produced by the RCN, and enable clinicians using evidence based guidance
to contextualise and understand the importance of preparation and planning prior to using this
evidence based tool. Development of a clinical guideline is recognised to be a large
commitment by the group of clinicians, patients, subject specialists and the technical team
responsible for producing evidence sourced recommendations to the NHS in England and
Wales. In understanding the contextual and organisational challenges, a foundation is laid for
the effective implementation of this guidance.
2.1.1 Person-centred care
Patients and carers should be made aware of the guideline and its recommendations
and be referred to the version, Information for Patients and Carers.
Patients and carers should understand decisions made about the management of
surgical site infection, and have the opportunity to ask questions.
Patients and carers should be informed about any potential risks and/or complications of
surgical site infection.
Patients and carers should be informed about the use of appropriate secondary
dressing materials used to augment the primary wound care dressings used in the
treatment of SSI.
2.1.2 A collaborative inter-disciplinary approach to care
All members of the interdisciplinary team should be aware of the guidelines and all care
should be documented in the patients healthcare records.
The approach to care should be an interdisciplinary one involving all appropriate people
in the management of surgical patient care.
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2.1.3 Organisational issues 1
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There should be an integrated approach to the management of surgical site infection with
a clear strategy and policy supported by management.
Care should be delivered in a context of continuous quality improvement, where
improvements to care following guideline implementation are the subject of regular
feedback and audit. This guideline provides opportunity through using the audit tool to
both monitor and inform current practice around the care of SSI.
Commitment to, and availability of, education and training are needed to ensure that all
staff, regardless of profession, are given the opportunity to update their knowledge and
are able to implement the guideline recommendations.
The healthcare team should have undergone appropriate training and have demonstrated
competence in perioperative care.
Staffing levels and skill mix should reflect the needs of patients, and are paramount to
providing high quality services for people who are given preventative treatment for, and
management of an SSI.
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2.2 Summary of guideline recommendations (please refer to section 5 for system
used to grade recommendations).
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Preoperative phase
Preoperative Showering
On the day of surgery, patients should whole body shower with a cleansing agent prior to the clinical
procedure. [B]
Preoperative Hair Removal
On the day of surgery, preoperative hair removal, when clinically indicated, should be undertaken
using clippers. [A]
Single-use clipper heads should be used. [GPP]
Bowel Preparation
The use of preoperative bowel preparation for elective colonic surgery is not recommended. [A]
Intraoperative phase
Hand Hygiene (Part A) Hand Decontamination
The GDG supports the principles of hand hygiene as presented in NICE guideline number 2;
Prevention of healthcare-associated infection in primary and community care.
Hands must be decontaminated immediately before each and every episode of direct patient contact
or care and after any activity or contact that could potentially result in hands becoming contaminated.
[B]
Hands that are visibly soiled, or potentially grossly contaminated with dirt or organic material, must be
washed with liquid soap and water. [A]
Hands must be decontaminated, preferably with an alcohol-based hand rub unless hands are visibly
soiled, between caring for different patients or between different care activities for the same patient.
[A]
Before regular decontamination begins, all wrist and ideally hand jewellery should be removed. Cuts
and abrasions must be covered with waterproof dressings. Fingernails should be kept short, clean and
free from nail polish. [D]
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An effective hand washing technique involves three stages: preparation, washing and rinsing, and
drying. Preparation requires wetting hands under tepid running water before applying liquid soap or an
antimicrobial preparation. The hand wash solution must come into contact with all of the surfaces of
the hand. The hands must be rubbed together vigorously for a minimum of 10-15 seconds, paying
particular attention to the tips of the fingers, the thumbs and the areas between the fingers. Hands
should be rinsed thoroughly before drying with good quality paper towels. [D]
When decontaminating hands using an alcohol handrub, hands should be free form dirt and organic
material. The handrub solution must come into contact with all surfaces of the hand. The hands must
be rubbed together vigorously, paying particular attention to the tips of the fingers, the thumbs and the
areas between the fingers, until the solution has evaporated and the hands are dry. [D]
An emollient hand cream should be applied regularly to protect skin from the drying effects of regular
hand decontamination. If a particular soap, antimicrobial hand wash or alcohol product causes skin
irritation an occupational health team should be consulted. [D]
Hand Hygiene (Part B) - Nail polish and finger rings
Fingernails should be kept clean and short. Nail polish, nail extensions and hand jewellery should be
removed before hand decontamination. [D]
Non-sterile Theatre wear (Scrubs)
Any person who is to be present during a sterile surgical procedure within an operating theatre should
change from civilian clothes and shoes into designated theatre wear (including headwear) before
entering that area. [D]
Consideration should be given to using reusable surgical scrubs in preference to disposable scrubs.
[D]
Surgical Scrubbing
The surgeon, surgical assistant and scrub theatre practitioner should use a scrub technique at the start
of their involvement in the operative list. An alcoholic rub should be used between operations and/or
for dressing changes in a clean environment. [D]
Sterile Theatre wear
The decision to use full, minimal or no sterile surgical attire to protect patients from SSI should be
made after risk assessment, taking into account the nature of the surgical procedure. [D]
Consideration should be given to using disposable gowns in conjunction with disposable drapes. [D]
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Double Gloving
Double gloving should be practised during procedures that have a high risk of glove perforation. [D]
Face Masks
The decision to use face masks to protect patients from SSI should be made after appropriate risk
assessment has been performed, taking into account clinical judgement appropriate to the surgical
procedure. [D]
Face masks can be used for the protection of staff from infection in clinically appropriate surgical
procedures (e.g. orthopaedic surgery). [D]
Preoperative Skin Antiseptics
When choosing to use antiseptics on specific areas of the body (such as mucous membranes),
consideration should be given to known contraindications. Topical iodine should not be used on
neonates and infants. [D]
Aqueous povidone iodine and aqueous chlorhexidine are acceptable skin cleansing agents. Alcohol
based solutions should be used sparingly for safety reasons. [D]
Where clinically indicated, a single application of aqueous povidone iodine is sufficient. [B]
Drapes
Disposable, sterile, single use drapes should be used for sterile surgical procedures that involve an
incision. [D]
Impregnated or non-impregnated incise drapes can be used as the clinician prefers. [D]
Perioperative Warming
In major surgery, the maintenance of normothermia intraoperatively is recommended unless there are
clinical contraindications. [A]
In minor procedures of short duration, systemic or local pre-operative warming is recommended. [A]
Perioperative Oxygen
80% oxygen should be used perioperatively in major surgery except where clinically contraindicated.
[A]
Intracavity Solutions
If clinically indicated, body cavities should be irrigated with warmed (37C), sterile saline. [GPP]
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Intracavity irrigation with dilute solution of povidone iodine in saline is indicated in adult orthopaedic
surgery. [A]
Intraoperative skin antiseptics
Re-disinfection of the wound prior to final skin closure is not indicated. [A]
Closure Methods and Techniques
Skin should be closed with either staples, or a non-absorbable monofilament suture using an
interrupted percutaneous technique. [A]
Tissue adhesives should be used with caution as they are associated with an increased wound
dehiscence rate. [B]
If there are extenuating clinical contraindications, or difficulties are anticipated in the removal of either
staples or sutures (such as in children), consideration should be given to an alternative method of skin
closure, for instance an absorbable subcuticular suture. [D]
The abdominal wall should be closed with an absorbable suture. [A]
Wound Dressings for surgical sites
If a surgical wound healing by primary intention requires a dressing (for exudate management or
protection), a low adherent, modern dressing should be used. [D]
Postoperative phase
Clean versus sterile
The individual patients risk of infection and the reduced cost of a clean dressing technique should be
taken into account by the healthcare professional when deciding whether to use clean or sterile
dressing techniques. [D]
Postoperative Wound Cleansing
Patients can choose to shower from 24 hours postoperatively, unless clinically contraindicated. [B]
Dressings and Topical Agents for wound healing by secondary intention
For dirty or infected wounds healing by secondary intention, polyurethane foam (a modern interactive
dressing) should be used in preference to gauze. [A]
For surgical wounds healing by secondary intention a modern interactive dressing should be used.
Foam, alginate and hydrocolloid dressings should be considered as first-line treatments. [D]
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Toenail avulsion
Following toenail avulsion an alginate dressing (a modern interactive dressing) should be used instead
of gauze. [A]
Other modern interactive dressings can also be considered with an appropriate secondary dressing,
as clinically indicated. [D]
Pin site Care
Pin sites should be kept clean to minimise the risk of infection. This is achieved through assessment
and the weekly removal of dried exudate. Pin sites may be covered with appropriate dressings. [GPP]
Treatments
Any use of an antibiotic for the management of SSIs should be based on information derived from a
clinical assessment process. This includes bacteriological screening (if possible) and referral to an
evidence-based local antibiotic formulary, produced as the result of multidisciplinary work between
clinician, pharmacist and microbiologist. [D]
Patients information needs, experiences, and quality of life issues
Patients undergoing surgery (and their carers) should be fully involved in their care plan and provided
with information on: how to reduce their risk of SSIs; wound management strategies; signs of
postoperative infection. [D]
Health professionals should be aware of the potential implication of a SSI on the physical and mental
wellbeing of patients and their carers. [D]
Patients who develop an SSI should be fully involved in their care plan. Patients experiencing long-
term effects from an SSI should also be given advice and support (e.g. DHSS benefits, transport, OT
aids) to ameliorate those effects. [GPP]
Patients should be fully informed regarding the potential warning signs of infection (local and
systemic). Local signs are an increase in redness, heat, pain, swelling, smell and wound discharge.
Systemic signs include fever. [GPP]
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3 BACKGROUND TO THE CURRENT GUIDELINES 1
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In March 2002, the National Collaborating Centre for Nursing and Supportive Care (NCC-
NSC) was commissioned by NICE to develop clinical and cost effective guidelines on Surgical
Site Infection (SSI). The remit from the DoH and Welsh Assembly Government was to
prepare guidance for the NHS in England and Wales on the prevention, management and
treatment of wounds. This particular guidance within that broad remit relates to surgical
wounds.
3.1 Clinical need for the guideline
The clinical need for evidence based guidance for the prevention of surgical site infection is
perhaps best illustrated by recent trends relating to the surveillance of healthcare-associated
infection, using orthopaedic surgery data in England since April 2004. There has been a
growing need since 1997 for the collection of data to be collected since 1997, with Trusts
volunteering to return data on this particular patient outcome. Surveillance is managed by the
Health Protection Agency on behalf of the Department of Health. A number of surgical
specialities are currently involved in generating this large data base which enables trends to
be established and decisions made regarding patient care. Clearly this process is important in
establishing the size of the problem and in determining the associated costs of addressing the
problem (treatment of SSIs).
3.2 Definition of SSI
SSI is defined as infection related to a surgical procedure that affects the surgical wound or
deeper tissues handled during the procedure. (DoH, 2006)
SSI typically presents as a postoperative complication occurring within 30 days following a
surgical procedure and is an important cause of morbidity and mortality for patients
undergoing surgery. The National Prevalence Survey of Infections in Hospitals (1996),
conducted in 157 hospitals in England, Scotland, Wales and Ireland involving data from
37,111 patients, reported an overall prevalence of hospital-acquired infection of 9.0%. Four
major groups of infections were identified: urinary tract infections; lower respiratory tract
infections; skin infections; and SSIs. The prevalence of SSI was 10.7%. Between 1997 and
2001, the Surgical Site Infection Surveillance Service (SSISS) reported an incidence of SSI of
4.2% from the participating 152 hospitals. Rates of SSI should be interpreted with caution, as
they simply represent estimates based on a sample of all procedures, and typically are from
relatively small data sets which may be imprecise. Data are subjected to normal quality
assurance with confidence intervals stated. That said, in the absence of prevalence studies,
surveillance data is the next best thing to understanding both the range and scope of the
problem.
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In looking at SSI, there are three clear areas of potential cause; these are in the preoperative,
intraoperative and postoperative phases of the patients clinical journey. In preparing for
guideline development, both patient related conditions and operation characteristics were
identified as potential risks of SSI development. In addition, the incidence of infected surgical
wounds may be influenced by factors such as preoperative care, the operating room
environment, postoperative care, the type of surgery, and care in the community.
3.3. Classification of SSI
Classification of the surgical wound is determined by the degree of contamination at the time
of surgery, divided into clean wounds; clean-contaminated wounds; contaminated wounds;
and dirty or infected wounds.
Classification of infection is determined by the depth of invasion of micro-organisms. Such
classification is described as superficial incisional involving the skin and subcutaneous
tissues; deep incisional involving the soft tissues (fascia and muscle); organ/space.
Current data indicate that at any one time, one in ten patients in acute hospitals have a
hospital-acquired infection (HAI) (DoH/PHLS, 1995). Concurrently, an unquantified number of
patients, discharged from hospital into the community have an infection related to their recent
hospital admission. On this basis, SSIs impose a burden on the secondary, tertiary and
primary health-care sectors, community care services, carers and the patients themselves at
significant financial and personal cost. Studies that have estimated the cost of HAI generally
focus on the burden to the hospital sector. Little is known about the costs incurred by the
primary healthcare sector, community care services, individual patients and their family and
friends. In a rapidly developing NHS where surgical advances and changes to service delivery
have typically reduced the inpatient time to a minimum, with over 70% of surgery conducted
as a day case, the full impact of this problem is difficult to estimate.
The Nosocomial Infection National Surveillance Scheme (NINSS), established in response to
the need for a defined programme of surveillance of infection in English hospitals, uses a risk
index (developed by NINSS, Centre for Disease Control, Atlanta USA) to stratify surgical
wound infection rates by risk factors. Risk category is determined by allocating a point for a
contaminated or dirty wound class, and is augmented by both the American Society of
Anaesthesiologists classification and the event of procedures lasting longer than expected for
that particular operation.
3.4 The socio-economic burden of Hospital Acquired Infection (HAI)
In a funded study by the Department of Health (DH), 1449 patients were selected for follow up
into the community following an episode of care (patients undergoing surgery included). The
results from this study showed that 215 patients had an infection identified during the in-
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patient phase. Incidence of acquired infection (one or more infections) was reported as 7.8%
(95% CI: 7.0; 8.6). In the post discharge phase of care 19.1% (95%CI: 16.5; 21.9) of
responding patients who did not have an HAI identified during the inpatient phase and 30%
(95%CI: 22.8; 38.0) of patients who had a HAI identified during the in-patient phase reported
symptoms and treatment that met the criteria for a urinary tract, chest and/or surgical wound
infection.
Hospital costs from HAI incurred during the in-patient phase for those patients presenting with
one or more infections during their in-patient stay were on average, 2.9 times greater than for
patients without infection. This represented an absolute increase of 3154 per case. After
adjusting for the effects of potential confounders the ratio (with/or without) was almost identical
(2.8; 95% CI: 2.6; 3.0), suggesting that confounding had relatively little effect. From the data,
the impact of SSIs was demonstrated to be a cost increase that was two to 2.5 times greater
than for patients who had surgery with no related infection, increasing the cost of the patient
episode on average between 1618 and 2398 per patient.
The co-morbidity impact of SSIs is also demonstrated powerfully in this study. For patients
who acquired more than one infection, costs per patient episode were increased on average,
by 6.6 times when compared to uninfected patients, equivalent to an additional 9152 per
patient episode. Cost impact is an important consideration for the NHS: length of hospital stay
also has a knock on effect for service delivery. Patients who acquired an SSI were (after
adjusting for other factors that might influence length of stay) demonstrated to have an
additional 7 days in hospital.
The argument and rationale is strong for evidence based guidance, combining best available
clinical and cost effectiveness data with expert opinion. Patient experience has demonstrated
an important impact of SSI on quality of life. Together, these provide the fundamental basis for
this timely guidance.
This guideline has been informed by NICE guidance on Infection Control; Prevention of
healthcare-associated infection in primary and community care. NICE Clinical Guideline No. 2
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4 AIMS OF THE GUIDELINE 1
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To evaluate and summarise the clinical and cost evidence relating to all aspects of the
prevention and treatment of surgical site infection
To highlight gaps in the research evidence
To formulate evidence-based and, where possible, cost-effective clinical practice
recommendations on prevention of surgical site infection based on the best evidence
available to the GDG.
4.1 Who the guideline is for
The guideline is of relevance to all healthcare professionals, health and social care staff that
are involved in the care of surgical patients. This may be within the secondary, tertiary and
primary health-care sectors, community care services, and will provide source material for
both patients undergoing surgery and their carers.
4.2 Groups covered by the guideline
People undergoing a surgical procedure that involves a visible surgical incision, and therefore
results in the presence of a conventional surgical wound (for example, laparotomy, inguinal
hernia and hip replacement surgery). Many general principles of management are
generalisable across the range of surgical procedures routinely performed in the NHS. This
guidance applies to both children and adults undergoing surgery.
4.3 Groups not covered
a) People undergoing a surgical procedure that does not involve a visible surgical incision, and
therefore does not result in the presence of a conventional surgical wound (for example,
vaginal hysterectomy, TURP, and oral surgery). However, many general principles of
management will be generalisable.
b) The guideline will not make recommendations for specific groups of patients at high risk of
developing an SSI or for particular types of surgical intervention.
c) The guideline does not cover lacerations and traumatic wounds
4.4 Healthcare setting
It is recognised that the NHS is rapidly developing patterns of service delivery, with a large
percentage of surgical procedures being performed as day surgery. Minor surgical procedures
are commonly performed in primary care settings such as general practice surgeries. The
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guideline has been developed to cover all current patterns of service delivery, with an
emphasis on raising the awareness of patients and the healthcare team to what they can do to
prevent SSIs.
4.5 Interventions covered
The following interventions will be covered, classified according to the perioperative period
and the nature of the intervention. These are grouped together relative to both the phases of
the surgical procedure and how they relate to the patient and healthcare team.
4.5.1 Preoperative
Patient specific: preoperative showering; preoperative hair removal and bowel preparation.
4.5.2. Intraoperative
Patient specific: preoperative skin antiseptics for preventing surgical wound infections;
perioperative warming; perioperative oxygen; intra-cavity solutions; Intra-operative antiseptics;
techniques and methods of closure (combining sutures and adhesives reviews); toenail
avulsion; wound dressings for surgical sites
Healthcare team: hand hygiene - removal of nail polish and finger rings; theatre wear non
sterile; surgical scrubbing; theatre wear sterile; double gloving; face masks; drapes.
4.5.3. Postoperative Phase (prevention and treatment)
Patient specific: Clean versus sterile techniques; wound cleansing; dressings and topical
agents for wounds healing by secondary intention; pin site care; treatments of infection for
surgical sites; patient views, experiences and information needs
4.6 Interventions not covered
The following interventions will not be covered:
management of antibiotic resistant bacterium
management of the operating theatre environment and environmental factors
4.6.1. Antibiotic anaphylaxis
Clinical guideline evidence on antibiotic prophylaxis in surgery has been produced by the
Scottish Intercollegiate Guidelines Network. This is planned for evidence updating in 2006 and
is expected to be published in 2007.
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4.7 Guideline Development Group 1
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The guideline recommendations were developed by a multidisciplinary and lay Guideline
Development Group (GDG) convened by the NICE-funded National Collaborating Centre for
Nursing and Supportive Care (NCC-NSC) with membership approved by NICE. Members
included representatives from patient groups; nursing; surgical medicine; pharmacy; tissue
viability specialism; microbiology; researchers staff from the NCC-NSC
See Appendix A for GDG membership. The GDG met 12 times between September 2004 and
March 2006. All members of the GDG were required to make formal declarations of interest at
the outset, which were recorded. GDG members were also asked to declare interests at the
beginning of each GDG meeting. This information is recorded in the meeting minutes and kept
on file at the NCC-NSC.
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5 METHODS USED TO DEVELOP THE GUIDELINE 1
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5.1 Summary of development process
The methods used to develop this guideline are based on those outlined by Eccles and Mason
(2001). The structure of the recommendations section (section 6) (ie, recommendations;
evidence statements, evidence narrative and guideline development group commentary) came
from McIntosh et al. (2001).
The stages used in the development of this guideline were as follows:
develop scope of guideline
NICE stakeholder review and feedback
convene multidisciplinary guideline development group
set review clinical questions
identify sources of evidence
retrieve potential evidence
evaluate potential evidence relating to clinical effectiveness, cost/economics and quality
of life, for eligibility, quality and relevance
extract relevant data from studies meeting methodological and clinical criteria
interpret each paper, taking into account the results (including, where reported,
beneficial and adverse effects of the interventions, cost, comfort and acceptability to
patients), the level of evidence, the quality of the studies, the size and precision of the
effect, and the relevance and generalisability of the included studies to the scope of the
guideline
analyse, where appropriate using statistical synthesis, the results reported in the studies
prepare evidence reviews and tables which summarize and grade the body of evidence
formulate conclusions about the body of available evidence based on the evidence
reviews by taking into account the above factors
agree final recommendations and apply recommendation gradings
submit drafts (short version and full version) of guideline for feedback from NICE
registered stakeholders
consider stakeholders comments (GDG)
submit final version of the guideline to NICE.
The main clinical questions addressed were as follows:
1: What are the best methods of patient preparation for the prevention of surgical site
infection (SSI)?
2. What is the most effective method of hand-cleansing by healthcare professionals for the
prevention of SSI?
3. What surgical attire worn by healthcare professionals is most effective for the prevention
of SSI?
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4. What are the most effective surgical techniques for the prevention of SSI?
5. What are the most effective methods of management of a postoperative surgical site?
6. a) Surgical site healing by primary intention
7. b) Surgical site healing by secondary intention
8. c) Infected surgical site
NCC-NSC staff and the health economist (GDG technical team) searched bibliographic
databases for evidence, examined and graded the evidence. The technical team then
composed successive drafts of the recommendations and guideline documents (including the
full version of guideline; the NICE version and the quick reference guide), based on the
evidence reviews and GDG input and deliberations. The GDG formulated and initially graded
the recommendations. The NICE patient and public involvement programme produced the
information for the public version, using the NICE version of the guideline, in collaboration with
the NCC-NSC. The decision relating to the removal of graded recommendations was taken by
the NICE Executive Board, coming into effect from April 1
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2006. This was discussed by the
GDG who agreed to present recommendations in this guideline without letter grading in the
NICE version. This version keeps the letter grading for the purpose of clarity in demonstrating
the linear relationship between evidence review, levels of evidence, recommendation
development and grading.
The general methods for the evidence reviews are reported in sections 5.2 and 5.3. This linear
relationship, demonstrating the relationship between the clinical and cost effectiveness results,
evidence statements and resulting recommendations, is reported for each review in sections
6.1 to 6.24.
The search strategies for the reviews are presented in Appendices C1 to C24. The included
studies for each review are reported in Appendices D1 to D24; the methodological
assessments of the included studies are in Appendices E1 to E24 and the studies excluded
from each review are listed in Appendices F1 to F24.
5.2 Clinical effectiveness review methods
5.2.1 Selection criteria
The following selection criteria were applied to studies to determine their suitability for
inclusion in the reviews:
Types of studies
Randomised trials (RCTs) comparing interventions for the prevention or management of SSI.
Where there were no randomised trials, we included quasi randomised designs (e.g. allocation
by systematic methods such as alternation, date of birth).
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The types of studies included for the review on patients information needs, experiences and
quality of life issues, range from randomised trials to qualitative phenomenological
approaches.
Types of participants
Adults and children undergoing an incisional surgical procedure, including a surgical implant.
Types of intervention
The interventions varied across reviews and are detailed at the beginning of each results
section.
Types of outcome
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For prevention:
Primary outcomes
Rates of surgical site infection, defined as a postoperative complication occurring within
30 days following a surgical procedure. Indications for SSI include: pus, or a swab with
more than 1 million ( >10
6
) colony forming units (cfu) per mm tissue and at least one of
the following signs or symptoms: pain, localised swelling, redness or heat (Mangram
1999). The GDG did not consider studies for which the time of registering wound
infections was less than seven days. This decision to exclude evidence reporting <7 days
postoperatively was based on clinical judgement, due to the uncertainty that the cause of
the infection was surgery related.
In some studies, other outcomes were measured, which could be construed as surrogates for
SSI. Generally surrogate measures are used when it is impossible or impractical to measure
the true outcome. For validity there is a need to have independent evidence of correlations
between the surrogate and desired outcome measures. The GDG discussed whether there
were any acceptable surrogate outcomes for SSIs. They decided that, as it is usually possible
to measure the rate of SSI, surrogate outcomes could be taken into account only to advise
GDG consensus decisions (with the recommendation being graded as D or GPP). The
following surrogates were considered, but there was some doubt about their validity:
Causal bacteria (cfu counts)
Number of perforations (gloves)
Wound inflammation was not considered to be a surrogate for SSI.
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Secondary Outcomes
Rate of healing (including time to complete healing, rate of change in the area/volume of
the wound)
Wound dehiscence / stitch abscess
Depth of infection (deep / superficial)
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Length of hospital stay
Mortality rate due to SSI
Adverse effects (e.g. toxicity, allergies, pain)
Incidence of septicaemia
Postoperative antibiotic use
Re-admission to hospital
Patient satisfaction
Healthcare professional satisfaction
In addition, other secondary outcomes were reported that allowed assessment of the
intervention in its full context, but were not usually related to infection and/or were specific for
particular reviews. These included:
Anastomotic leakage (bowel preparation)
Re-operation (bowel preparation)
Infectious extra-abdominal complication (bowel preparation)
Staff acceptability (theatre attire)
Acceptability of finger ring removal (nail polish)
Absorbency (theatre attire)
Ease of handling (theatre attire)
Incisional hernia (methods of closure)
Cosmetic appearance (methods of closure)
Ease of removal (methods of closure, dressings)
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For postoperative prevention and treatment
Primary outcome
Rate of healing (time to complete healing; proportion of wounds healed in a specified time
period; rate of change in the surface area/volume of the wound)
Secondary outcomes
Infection cure or improvement rates any objective or subjective measure as defined by
the study authors. This may include subjective assessments of pain, pus, swelling,
redness or heat
Pain
Exudate
Scarring
Ease of removal (dressings)
Complications and morbidity
Mortality
Patient related outcomes: comfort, satisfaction, acceptability of the intervention
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Length of stay
Quality of life data: generic or specific measures of quality of life
Number of carer visits
Re-admission rates
5.2.2 Search Strategy
search terms (can refer to Appendix)
databases
dates
The search strategies and the databases searched are presented in Appendix C. All searches
were comprehensive and included a large number of databases. All search strategies were
adapted for smaller or simpler databases or for web-based sources which did not allow
complex strategies or multi-term searching.
A combination of subject heading and free text searches were used for all areas. Free text
terms were checked on the major databases to ensure that they captured descriptor terms and
their exploded terms.
Hand-searching was not undertaken following NICE advise that exhaustive searching on every
guideline review topic is not practical and efficient (Mason et al. 2002).
Reference lists of articles were checked for articles of potential relevance.
5.2.3 Sifting process
Once articles were retrieved the following sifting process took place:
1st sift: Sift for material that potentially meets eligibility criteria on basis of title/abstract
by one reviewer;
2nd sift: Full papers ordered that appear relevant and eligible or where
relevance/eligibility not clear from the abstract;
3rd sift: Full articles are appraised that meet eligibility criteria.
5.2.4 Data abstraction
Data from included studies were extracted by one reviewer for each review into pre-prepared
data extraction tables. The following data were extracted from each study:
patient inclusion/exclusion criteria
care setting
key baseline variables by group
description of the interventions and numbers of patients randomised to each intervention
description of any co-interventions/standard care
duration and extent of follow up
outcomes measured and results
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acceptability and reliability if reported
If studies were published more than once, the most detailed report was used as the basis of
the data extraction
Masked assessment, whereby data extractors are blind to the details of journal, authors etc,
was not undertaken because there is no evidence to support the claim that this minimises bias
(Cullum et al, 2003).
Once individual papers were retrieved, the articles were checked for methodological rigour
(using quality checklists appropriate for each study design), applicability to the UK and clinical
significance. Assessment of study quality concentrated on dimensions of internal validity and
external validity. Information from each study that met the quality criteria was summarised and
entered into evidence tables.
5.2.5 Appraisal of methodological quality
The methodological quality of each trial was assessed by one reviewer and checked by the 13
senior research fellow. The following quality criteria were used: 14
15 description of a priori sample size calculation
16 description of method of generation of the randomisation sequence
17 evidence of allocation concealment at randomisation
18 description of baseline comparability of treatment groups
19 outcome assessor stated to be blinded
20 evidence that loss to follow up for each outcome was not more than 20% for each group
for the outcome of rate of SSI, evidence that recordings were made not less than seven 21
days post-operatively 22
23 5.2.6 Data synthesis
Some areas of the guideline were the subject of Cochrane Reviews, for these updating and re- 24
analysis was carried out as necessary. We conducted meta-analyses, where appropriate, for 25
other topics. 26
Meta-analysis of similar trials, where appropriate, was carried out using The Cochrane 27
Collaborations analysis software, Review Manager (Version 4.2). Trials were pooled using a 28
fixed effects model and plotted on forest plots. 29
Where it was possible to combine studies, outcomes were summarised for dichotomous data 30
using odds ratios (as default), relative risks (where the event rate was greater than 20%), or 31
Peto odds ratios (where there were studies with no events) For continuous data, weighted 32
mean differences for continuous data. Summary statistics and their 95% confidence intervals 33
(95% CI) were reported where sufficient detail allowed their calculation. 34
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We assessed heterogeneity between trials by visual inspection of forest plots, noting where 1
there was poor overlap of horizontal lines, and by using statistical measures: the
2
test for 2
heterogeneity and the level of inconsistency, I
2
(I
2
= [(
2
df)/
2
] x 100%, where df is the 3
degrees of freedom). We considered that there was heterogeneity if p<0.1 and/or
I
2
>50%. Any 4
heterogeneity was explored further and unexplained heterogeneous results were not used as 5
the basis for recommendations. 6
Subgroup analyses were carried out in order to investigate heterogeneity; the following 7
general pre-specified factors were investigated: 8
9 Nature of surgery (clean, clean-contaminated, contaminated, dirty).
10 Subgroup analyses specific to each review were also carried out.
For the guideline analyses, we did not combine truly randomised trials and quasi-randomised 11
trials (e.g. sequence generation by alternate allocation or by date of birth) in a meta-analysis - 12
where both types of design were present, we excluded the quasi-randomised studies from the 13
analysis, as they represented a potentially higher risk of bias. Other studies that were 14
potentially biased were those with large numbers (more than 20%) of withdrawals or protocol 15
deviations in any group (that were eliminated from the studys analyses). Where quasi- 16
randomised studies represented the only evidence, they were analysed separately and graded 17
accordingly. 18
Some meta-analyses gave pooled summary statistics close to the null value. Where the 19
confidence interval was narrow, we considered this to be evidence for little difference 20
between interventions and the approach became similar to that of an equivalence trial 21
(Alderson 2004). Where the confidence interval was wide, there was considered to be 22
insufficient information to determine if there was a difference between interventions. For most 23
outcomes, the GDG judged what constituted a wide confidence interval; if there was any 24
doubt, they decided there was uncertainty. For the continuous outcome, length of stay in 25
hospital, the GDG decided that a confidence interval of greater than 14 days should be 26
considered to be wide. 27
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31
32
33
34
5.3 Cost effectiveness review methods
5.3.1 Background
The aims of the review were to:
1. Identify publications assessing the cost of surgical site infections in the UK
2. Identify economic evaluations of intervention for the prevention and/or treatment of
surgical site infections covered by the guideline. By definition an economic evaluation
compares the costs and outcomes of at least two health interventions;
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3. Find studies with relevant resource use and cost data to facilitate possible cost-
effectiveness
The health economics glossary provides more information on the different types of economic 3
study. 4
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5.3.2 Selection criteria
For selection of relevant health economics evidence, the following criteria were used:
Only those studies in the English language were included in the review.
No restriction was placed on publication status of papers.
Year of publication restrictions were identical to the clinical literature review section.
Selection criteria based on clinical conditions, patients, interventions and settings were
identical to the clinical literature review section.
All types of economic evidence were considered for inclusion, regardless of clinical study
design. However, this was subject to the study providing sufficient details on methods and
results to enable judgement of the quality of the study.
For studies evaluating the costs of surgical site infection, only studies within a UK setting were
included in the review. However, to identify other health economics information relevant to a
UK setting economic evaluations from OECD countries or member states of the European
Union were included in the review.
5.3.3 Search strategies for reviews of economic evaluations, costing studies
Several health economic databases were searched for studies that evaluated any intervention
for SSI. These were NHS EED (NHS Economic Evaluation Database), OHE HEED (Office of
Health Economic Evaluations Database), HTA (Health Technology Assessment), and DARE
(Database of Abstracts of Reviews of Effectiveness). No date limit was applied to these
searches.
Medline, Embase and Cinahl were searched using a combination of a specially developed
health economics search filter combined with the clinical search terms for each topic assessed
in the guideline. However, where the clinical search strategy used terms to identify particular
study designs (e.g. randomised trials) we omitted these restrictions in our search strategy The
same search dates used in searching for the clinical evidence were used in the searches for
economic evidence.
The search strategies and the databases searched are presented in Appendix C.
5.3.4 Sifting process
Titles and abstracts of all references were checked to identify papers of potential relevance.
The full texts of all potential eligible studies or for those studies where relevance and/or
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eligibility was not clear from title and abstract were obtained. All full texts obtained were then
tested by the health economist against the selection criteria detailed below.
All those papers included in the review were then quality assessed using the British Medical
Journal checklist for economic evaluations (Drummond and Jefferson, 1996), and a shortened
version of this checklist in the case of costing studies.
5.3.5 Data abstraction
9 For the cost effectiveness studies, the following data were abstracted by a single abstractor:
10 details of the study design;
11 details of the study population;
12 details of the intervention;
13 details of individual outcome measures used
14 details of and source of effectiveness data in economic models, for example, RCT;
15 methods of collecting cost data - for example, micro level costing;
16 assumptions made by authors developing economic models;
17 estimates of the cost effectiveness and range;
18 generalisability to the UK context.
19 For the cost studies, the following data were abstracted by a single abstractor:
study design or source of information, reference, date and potential problems with 20
source; 21
22 perspective of costing;
23 intervention costed;
24 estimate of cost and range;
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generalisability to the UK setting.
5.3.6 Further economic modelling
There were a number of topics in the guidelines where there was only limited economic
evidence available. However, as the guideline has a broad scope it was not possible within the
time frame to provide an economic model for all topics. Areas requiring further economic
analysis were identified by the health economist in conjunction with the Guideline
Development Group (GDG) members. Topics for modelling were prioritised according to the
following criteria:
The resource implications to the NHS of the proposed health intervention;
Challenge current clinical practice;
Lack of consensus amongst clinicians on interventions to follow;
Sufficient data to allow for useful modelling; and
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Any other factor deemed relevant by the GDG member.
Modelling was undertaken for the following areas of the guideline: preoperative antiseptics,
preoperative hair removal, surgical face masks, and double gloving. The methods and data
used for these economic models are reported in each evidence review (sections 6.1 to 6.25).
The quality checklists for economic studies are given in Appendix G.
5.4 Submission of evidence
Stakeholders registered with NICE (see Appendix B) were invited to submit a list of evidence
for consideration to ensure that relevant material to inform the evidence base was not missed.
The criteria for the evidence included:
systematic reviews
randomised trials (RCTs) that examine clinical or cost effectiveness, and/or quality of life
and economic analyses based on these findings
representative epidemiological observational studies
qualitative studies/surveys that examine patient/carer experiences
studies of any design which have attempted to formally:
assess the cost effectiveness/utility of interventions for the prevention or
management of SSI
assess the cost of having a surgical site infection
assess quality of life or used cost-utilities in relation to surgical site infections
Information not considered as evidence included:
studies with weak designs when better studies are available
commercial in confidence material
unpublished secondary endpoint trial data, data-on-file and economic modelling
promotional literature
papers, commentaries or editorials that interpret the results of a published study
representations or experiences of individuals not collected as part of properly designed
research
Initial submissions were received from:
ConvaTec
Johnson & Johnson Medical
Kimberley Clark
Smith & Nephew Healthcare
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All references were screened for relevance and design criteria and those considered eligible
were checked with our databases to ensure our search had captured such studies.
5.5 Evidence synthesis and grading
Evidence gradings were assigned to each evidence review using the evidence hierarchy
shown below (Table 2). This hierarchy is recommended for intervention studies by NICE at the
time of writing. Studies or meta-analyses with a minus rating were not used as a basis for
recommendations.
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1 Table 2: Levels of evidence
Level of
evidence
Type of evidence
1
++
High-quality meta-analyses, systematic reviews of RCTs, or
RCTs with a very low risk of bias
1
+
Well-conducted meta-analyses, systematic reviews of RCTs,
or RCTs with a low risk of bias
1