Surgical Site Infection (SSI)

Revisiting the Surgical Site Infection
Bundle of Care: does it really work?
Domingo S. Bongala, Jr., MD, FPSGS, FPCS, FACS

Items for Discussion
•  Risk factors and risk reduction measures for SSI
•  Evolution of care to a bundles approach
•  Evidence for/against the bundles approach
•  Conclusions

•  techniques that reduce the risk of SSI dates back to the
1970s but these practices have not been implemented
universally
•  many SSI prevention measures have shown impressive
results when tested individually in large, well-controlled
randomized trials

High Quality Evidence
•  intravenous antibiotics within 60 minutes of surgery with
dosing based on weight and again at time intervals
based on the antibiotic's half-life
•  preoperative bowel preparation with oral antibiotics
•  chlorhexidine with alcohol in preference to povidone
-iodine skin preparation
•  normoglycemia in the perioperative period

High Quality Evidence
•  maintenance of intraoperative normothermia
•  optimization of patient risk factors such as smoking
cessation
•  control of diabetes
•  improved nutrition as measured by serum
albumin level
•  laparoscopic rather than open surgery
•  prevention of contamination during surgery

Moderate Quality Evidence

supplemental perioperative oxygen
Low Quality Evidence
with a very low potential of adverse effect
perioperative antibacterial showers
topical antibacterial and antiseptic agents
antibacterial irrigation
antibacterial-coated sutures
wound sealants
antibacterial impregnated dressings

Preoperative bathing or showering with skin antiseptics
to prevent surgical site infection
Webster and Osborne
Cochrane Collaboration Issue 2, 2015
-  preoperative bathing or showering with an antiseptic skin
wash product is a well-accepted procedure for reducing
skin bacteria (microflora)
-  less clear whether reducing skin microflora leads to a
lower incidence of surgical site infection
- review the evidence for preoperative bathing or showering
with antiseptics for preventing hospital-acquired (nosocomial)
surgical site infections (5th update)
- 7 RCTs (n = 10,157)

Preoperative bathing or showering with skin antiseptics
to prevent surgical site infection
Webster and Osborne
Cochrane Collaboration Issue 2, 2015
Comparator Studies N Risk Ratio
placebo 4 7791 0.91 (0.80, 1.04)
bar soap 3 1443 1.02 (0.57, 1.84)
no wash 3 1142 0.82 (0.26, 2.62)
SSI rates after using Chlorhexidine 4% vs. comparator
no clear evidence of benefit for preoperative showering
or bathing with chlorhexidine over other wash products
to reduce surgical site infection

•  National Surgical Infection Prevention (SIP) project
(2004) primarily focused on prophylactic antibiotic use
•  experience on a national level has shown that improved
compliance with a single process measure in a complex
environment is unlikely to have an appreciable effect on
the desired outcome
•  Surgical Care Improvement Project (2006) - measures to
prevent SSIs by achieving a 95% compliance rate

•  even high compliance with SCIP measures is not directly
associated with reducing SSI rates
•  variation in practice may be one of contributors to the
differences in SSI and mortality rates seen among
hospitals (institution-specific nature of SSIs)

•  results not as impressive when assessed in real-world
applications
•  success of SCIP in reducing SSI is in doubt but the
addition of other evidence-based measures to SCIP
might improve SSI rates
•  systematic approaches, or bundles, directed toward the
incorporation of best practices across the phases of
perioperative care

What is a bundle of care ?
•  limited number (3–5) of evidence-based
recommendations that should be performed during
medical procedures carrying a high intrinsic risk of a
complication
•  important tools to improve the process of care and
thereby patient outcomes
•  zero-tolerance policy essential (all bundle components
are adhered to in every single patient)

•  the bundle creates a culture of safety
•  process measures that should be implemented with a
compliance of at least 90%
•  SSI rate measured to quantify effect of interventions on
outcome

What is the evidence for the SSI bundle of care?

Improving SSI: Using NSQIP Data to Institute
SCIP Protocols in Improving Surgical Outcomes
Berenguer, Ochsner, Lord et al
J Am Coll Surg 2010;210:737–743
Prospective cohort (n = 197) colorectal cases
Memorial University Medical Center
July 2006 to June 2007 (n = 113)
July 2007 to June 2008 (n = 84)
comparing time periods before and after implementation
to look at ability of SCIP measures to decrease SSI

J Am Coll Surg 2010;210:737–743
Intervention
appropriate timing of antibiotics
choice of antibiotics
discontinuation of prophylactic antibiotics within 24
hours
Use of clippers
Postoperative normothermia

J Am Coll Surg 2010;210:737–743
Rates of superficial SSI in MUMC and NSQIP

13.3%
8.3 %
As compliance with SCIP improved from 38% to 92%,
rates of superficial SSI decreased by 38 %

A bundle of care to reduce colorectal surgical infections:
an Australian experience
Bull, Wilson, Worth, et al.
Journal of Hospital Infection 78 (2011) 297e301
Cohort (n = 455) colorectal operations
Dandenong Hospital (315-bed acute tertiary referral hospital)
implementation phase (January 2009 - June 2009) (n = 133)
sustainability phase (July 2009 - December 2009) (n = 142)
assess the feasibility of implementing a bundle of care
for patients undergoing colorectal surgery with the aim of
reducing surgical site infections

Intervention
Temperature maintained >36 C peri-operatively and for 1 hour
postoperatively
Fraction of inspired oxygen delivered maintained >0.8 intra-operatively;
adequate oxygenation for 4 hours postoperatively
Systolic BP maintained >90 mmHg intra- and postoperatively
blood sugar level maintained <10 mmol pre- and intra-operatively
Appropriate antibiotic prophylaxis given

Time Crude infection rate
Prior to study 15 % (10.4 – 20.2)
Implementation phase 9 % (4.8 – 15.2)
Sustainability phase 7 % (3.4 – 12.6)
Introduction of a bundle of care was only modestly successful

Colorectal Surgery SSI Reduction Program: A NSQIP-Driven
Multidisciplinary Single-Institution Experience
Cima, Dankbar, Lovely, et al.
J Am Coll Surg 2013;216:23e33.

Cohort (n = 729)
Mayo Clinic
2009 – 2010 (n = 531)
2011 (n = 198)
measure the effect on the SSI rate after
Implementing the bundle of care in colorectal surgery


Overall SSI Rates
9.84 %
4.0 %
bundle resulted in a substantial and
sustained decline in SSIs

Reduction of Surgical Site Infections after
Implementation of a Bundle of Care
Crolla, van der Laan, Veen, et al
Plos One 2012;7:e44599
Cohort (n =771) colorectal surgeries
Amphia Hospital, Netherlands
January 2008 – January 2012
measure the effect on the SSI rate after
Implementing the bundle of care in colorectal surgery

Plos One 2012;7:e44599
Meaasure Definition
normothermia temperature between 36.0°C and 38.0°C at the end of
the surgical procedure
Perioperative
prophylaxis
correct drug given between 15 and 60 minutes before
the incision
Hair removal preferably not performed and when it was done a
clipper had to be used
number of
door-openings
from opening of sterile equipment until surgical wound
was closed (<10 per hour)

Plos One 2012;7:e44599
Annual Changes in SSI rate and bundle compliance
improvements with implementation of the bundle
were followed by subsequent reductions in SSI rate
21.5%
16.1%

Efficacy of Protocol Implementation on Incidence of
Wound Infection in Colorectal Operations
Hedrick, Heckman, Smith, et al
J Am Coll Surg 2007;205:432–438
Cohort (n = 307) colorectal surgeries
University of Virginia
February 2000 to January 2002 (n = 175)
January 2005 to August 2005 (n = 132)
implementation of a multidisciplinary wound management
protocol targeting these risk factors would reduce
the incidence of SSI

J Am Coll Surg 2007;205:432–438
Intervention pre post p
Appropriate antibiotic administration 68 % 91 % 0.0001
Discontinued within 24 hours 71 % 93 % 0.0001
Normothermia (> 36°C) 64 % 71 % 0.27
Perioperative glucose (mg/dL) 162.2 +12.8 143.6+9.2 0.23
Compliance measures and rates

J Am Coll Surg 2007;205:432–438
Patient Outcome pre post P value
SSI 45 (26 %) 21 (16 %) 0.04
Length of stay 12.3 + 2.4 (7 %) 6.9 + 0.3 (5 %) 0.05
Mortality 1 (0.6 %) 1 (0.8 %) 0.84
Incidence of SSI improved by 39 % after implementation
of a multidisciplinary wound-management protocol

The Preventive SSI Bundle in Colorectal Surgery
Keenan, Speicher, Thacker, et al.
JAMA Surg. 2014;149(10):1045-1052
Duke University Medical Center
January 2008 – June 2011 (n = 346)
July 2011 – December 2012 (n = 213)
determine the effect of a preventive SSI bundle
on SSI rates and costs in colorectal surgery

JAMA Surg. 2014;149(10):1045-1052

JAMA Surg. 2014;149(10):1045-1052
Outcome Prebundle Postbundle P value
Superficial SSI 41 (19.3%) 12 (5.7%) <.001
Deep SSI 3 (1.4%) 0 .25
Organ/space SSI 11 (5.2%) 6 (2.8%) .32
Wound disruption 5 (2.4%) 3 (1.4%) .72
Post-operative sepsis 18 (8.5%) 5 (2.4%) .009
Length of stay (median) 5.5 (4-8) 5.0 (3-7) .05
Outcomes after Propensity Matching
Preventive SSI bundle was associated with a
substantial reduction in SSIs after colorectal surgery

Outcome of a Strategy To Reduce Surgical Site Infection
in a Tertiary-Care Hospital
Cohort (n = 2,408) of gastrointestinal procedures
public tertiary care hospital in Singapore
All class I/II elective GI and hernia operations
Jan 2006 – Dec 2007
Liau, Aung, Chua, et al
Surgical infections 2010 :11, 2: 151-159
876 hernia (36 %)
901 hepatopancreaticobiliary (37 %)
423 colorectal (18 %)
161 upper GI ( 7 %)
44 abdominal cavity ( 2 %)

Prospective cohort (n = 2,408)
public tertiary care hospital in Singapore
Intervention Compliance
Standardized prophylactic regimen &
administration within 30 minutes of incision
87 %
Standardized glucose monitoring for diabetics
(<11.1 mmol/L)
89 %
Maintenance of post-operative normothermia 44 %
Clippers for hair removal 98 %

84 % reduction in SSI in 2 years (from 3.1% to 0.5%) (p<0.001)
Bundle of interventions can reduce SSI rates

A Colorectal “Care Bundle” to Reduce SSI in
Colorectal Surgeries: A Single-Center Experience

Lutfiyya, Parsons, and Greene
Perm J 2012 Summer;16(3):10-16
Kaiser Sunnyside Medical Center
January 2006 – December 2009 (n = 430)
January 2010 - June 2011 (n = 195)
evaluate application of a “care bundle” for patients undergoing
colorectal operations in reducing overall SSI rates

Perm J 2012 Summer;16(3):10-16

A Colorectal “Care Bundle” to Reduce SSI in
Colorectal Surgeries: A Single-Center Experience

Perm J 2012 Summer;16(3):10-16
Colorectal Surgery SSI rates
91/430 (21.16%)
13/195 (6.67%)
absolute decrease in SSI rate of 14.49%
was highly significant (p < 0.0001)

An Increase in Compliance With the SCIP Measures
Does Not Prevent SSI in Colorectal Surgery
Pastor, Artinyan, Varma, et al
Dis Colon Rectum 2010; 53: 24 –30
Prospective cohort (n = 491) of colorectal surgeries
Tertiary institution
April 1, 2006 to May 31, 2007 (n = 238)
June 1, 2007 to July 31, 2008 (n = 253)
comparison between 2 consecutive 14-month periods
to determine association of compliance with process
measures and outcomes in infections

Intervention Time A Time B p
Correct antibiotic prophylaxis
Selection and dose 207 (87) 238 (90) .002
Start within 60 min 216 (91) 246 (97) .002
Redosing at 180 min 198 (83) 230 (91) .011
Discontinuation within 24 h 167 (70) 212 (84) <.001
Correct hair removal 238 (100) 253(100) 1.0
Postoperative normothermia (36–38°C) 193 (81) 239 (95) <.001
Perioperative glucose (<200 mg/dL) 167 (70) 180 (71) .95
Global compliance with SCIP measures 96 (40) 173 (68) <.001
Global compliance with all measures 71 (30) 127 (50) <.001

Prospective cohort (n = 491) of colorectal surgeries
99 patients (19%) developed SSI
Increase in compliance with the SCIP does not
translate into a significant reduction of SSI
period A 18.9% period B 19.4%

SCIP and SSI: can integration in the surgical safety checklist
improve quality performance and clinical outcomes?
Tillman, Wehbe-Janek, Hodges, et al.
Jour of Surg Research 2013:184: 150-156
compared SCIP compliance and patient outcomes for 1-year
before and 1-year after SSC implementation
- to determine if integration of SCIP measures within Surgical
Safety Checklist will improve SCIP performance and
patient outcomes for SSI

Cohort (n = 6,935) composite operations
Scott and White Memorial Hospital

SCIP and SSI: can integration in the surgical safety checklist
improve quality performance and clinical outcomes?
incorporating specific SSI reduction strategies into a standardized SSC
can be effective in improving process compliance and quality performance.
Intervention Pre-SSC Post-SSC p
Antibiotic timing 670/723 (92.7%) 557/584 (95.4%) <0.05
Antibiotic selection 707/735 (96.2%) 584/592 (98.7%) <0.01
Antibiotic end 636/677 (93.9%) 528/546 (96.7%) <0.05
Hair removal 1039/1044(99.5%) 914/918 (99.6%) 0.99
Perioperative temperature 723/771 (93.8%) 693/709 (97.7%) <.001

- no difference in SSI rates with a significant improvement in five of six SCIP
measures and all measures achieving greater than 95% compliance
- greater than 50% reduction in SSI rates in colorectal surgery group
Category Pre-SSC Post-SSC P value
Composite 104/3319 (3.13%) 107/3616 (2.96%) 0.72
Cardiac 6/81 (7.4%) 12/86 (13.9%) 0.22
Colorectal 19/79 (24.1%) 12/104 (11.5%) 0.03
General 52/838 (6.2%) 55/907 (6.1%) 0.92
Gynecologic 5/241 (2.1%) 7/260 (2.7%) 0.77
Thoracic 1/41 (2.4%) 3/43 (7.0%) 0.62
Vascular 3/121 (2.5%) 6/129 (4.7%) 0.50
Orthopedic 16/960 (1.7%) 7/1031 (0.7%) 0.06
SSI Rates according to type of operation

dose–response relationship between SSI and infection
prevention interventions / degree of compliance
(sum is better than the individual components)
Developing an argument for bundled interventions to reduce
surgical site infection in colorectal surgery
Waits, Fritze, Banerjee, et al.
Surgery 2014;155:602-6.
Cohort (n = 4,085)
24 community hospitals in Michigan
colorectal operations from 2008 - 2011

Surgery 2014;155:602-6.
Intervention
1 Appropriate selection of intravenous prophylactic antibiotics
2 Postoperative normothermia (temperature of >98.68F)
3 Oral antibiotics with mechanical bowel preparation
4 Postoperative day 1 glucose <140 mg/dL
5 Minimally invasive surgery
6 Short operative duration (incision to closure) <100 minutes

Association between progressive increase in the
implementation of the bundle elements with a
stepwise decrease in SSI
Surgery 2014;155:602-6.

Implementation of a Surgical Comprehensive Unit-Based
Safety Program to Reduce Surgical Site Infections
Wick, Hobson, Bennett, et al
J Am Coll Surg 2012;215:193–200
Johns Hopkins Hospital
July 2009 - June 2010 and July 2010 - July 2011)
to compare pre- and post-intervention SSI rates and
compliance with SCIP process measures

J Am Coll Surg 2012;215:193–200
Compliance rates pre- and post-intervention
Intervention Pre Post
Standardization of skin preparation and preoperative
chlorhexidine wash cloths
95 %
Selective elimination of mechanical bowel preparation
Warming of patients in the preanesthesia area 83 % 95 %
Enhanced sterile techniques
Addressing lapses in prophylactic antibiotics 95 % 95 %

J Am Coll Surg 2012;215:193–200
Variable Pre-intervention Post-intervention
Total operations 278 324
Overall SSI 76 (27.3 %) 59 (18.2 %)
Superficial SSI 47 (16.9 %) 44 (13.6 %)
Deep SSI 4 (1.4 %) 2 (0.6 %)
Organ/space SSI 25 (9.0 %) 13 (4.0 %)
Colorectal Surgery SSI Rates
there was a 33.3% decrease in SSI rates (95% CI, 9–58%;
p < 0.05) after the intervention

Evaluating an Evidence-Based Bundle for Preventing
Surgical Site Infection: A Randomized Trial
Anthony, Murray, Sum-Ping, et al.
Arch Surg. 2011;146(3):263-269.
RCT (n = 211) of transabdominal colorectal surgery
Veteran’s Administration teaching hospital
April 2007 - January 2010
to test the hypothesis that a series of evidence-based
interventions incorporated as a single bundle, would
significantly decrease overall SSI rate after elective
colorectal surgery

Arch Surg. 2011;146(3):263-269.
Extended Arm Intervention
omission of mechanical bowel preparation
preoperative and intraoperative warming using heating blanket to
maintain normothermia
maintenance of increased concentration of inspired oxygen (80%)
from intubation until 2 hours after surgery
reduction of intravenous fluid administration during the operation
use of plastic wound edge protection devise

Arch Surg. 2011;146(3):263-269.
Standard Arm Intervention
mechanical bowel preparation with oral antibiotics
intraoperative forced air warming to maintain normothermia
maintenance of physiologic concentration of inspired oxygen (30%)
after endotracheal intubation
intravenous fluid delivered at the discretion of the anesthesiologist
no wound edge protection

Arch Surg. 2011;146(3):263-269.

Arch Surg. 2011;146(3):263-269.
Extended Standard p value
SSI 45 % 24 % .003
Superficial 36 % 19 % .004
Organ-Space 9 % 5 % .59
Intention-to-treat SSI Rates
Over-all SSI rate of 35 % (69/197)

Arch Surg. 2011;146(3):263-269.
Overall SSI
rate in
population
with variable
present
Overall SSI
rate in
population
with variable
absent
P value
Extended study arm
assignment
45/100 (45 %) 24/97 (25 %) .004
Associations between perioperative variables and overall SSI rates
In intention-to-treat population
Univariate analysis showed significant association
only with study arm assignment

Arch Surg. 2011;146(3):263-269.
- logistic regression showed that only allocation to
extended arm was independently associated SSI
- bundle of intervention increased the risk of SSI
2.49-fold when compared with standard practice
- use of this bundle of interventions is not warranted
and raises significant questions concerning the
general wisdom of adopting bundled approaches
in other clinical situations

Do surgical care bundles reduce the risk of SSI
in patients undergoing colorectal surgery?
Tanner, Padley, Assadian, et al.
Surgery 2015;158:66-77
Systematic review and meta-analysis (n = 8,515)
(13 RCT, quasi-experimental studies, and cohort studies)
of care bundles to reduce SSI
individual studies of care bundles report conflicting outcomes
assesses the effectiveness of care bundles to reduce
SSI among patients undergoing colorectal surgery

Surgery 2015;158:66-77
PRISMA Diagram

Surgery 2015;158:66-77
Downs and Black checklist
- to assess the quality of all studies
- overall numeric score out of 30 points based on
5 themed sections
-  Overall study quality
-  External validity (ability to generalize of findings)
-  Study bias (in interventions and outcome measures)
-  Confounding and selection bias (in sampling)
-  Power (sample size)
-  studies were assessed as medium to high quality

Surgery 2015;158:66-77
-  none of the studies implemented identical SSI care bundles
-  all studies included elements from a core group of
evidence-based interventions including
-  appropriate antibiotic prophylaxis
-  normothermia
-  appropriate hair removal
-  glycemic control for hyperglycemic patients

Surgery 2015;158:66-77
Forest Plot

Surgery 2015;158:66-77
-  majority of the reviewed studies included a group of ‘‘core,’’
evidence-based interventions (based on RCTs and
systematic reviews)
-  level 1 evidence is lacking for several of the ‘‘non-core’’
interventions included in many of the care bundles analyzed

What is the optimal surgical care bundle
for decreasing the risk of colorectal SSIs?

•  Selective core elements should be viewed as baseline
considerations
–  normothermia
–  glycemic control
–  timely and appropriate antimicrobial prophylaxis
–  appropriate hair removal
•  these selective elements by themselves are not sufficient
to provide the comprehensive risk reduction benefit
required to reduce the overall risk of infection

What is the optimal surgical care bundle
for decreasing the risk of colorectal SSIs?
•  other evidence-based interventions may warrant further
consideration
–  mechanical bowel preparation plus oral antibiotics
–  supplemental oxygen
–  separate surgical tray for fascia and skin closure
–  wound protectors
–  antimicrobial sutures for fascial closure

CDC and HICPAC 2015 DRAFT Guideline
for Prevention of SSI
1.  Parenteral Antimicrobial Prophylaxis (AMP)
1a. Preoperative Timing
1b. Preoperative Timing in Cesarean Section
1c. Weight-based dosing
1d. Intraoperative redosing
2. Non-parenteral AMP
2a. Antimicrobial irrigation
2b. Topical antimicrobials
2c. Antimicrobial-coated sutures
2d. Antimicrobial dressings
3. Glycemic control
4. Normothermia
5. Achieving and maintaining normothermia
6. Oxygenation
7. Optimal target FiO2
8. Antiseptic prophylaxis
9. Skin prep repeat application prior to closure

Is there an evidence-based argument for embracing an
Antimicrobial (triclosan)-coated suture technology to
reduce the risk for surgical-site infections?: A meta-analysis

Edmiston, Daoud, Leper
Surgery 2013;154:89-100

Conclusions
•  unable to determine which elements impacted the results
•  regardless of the interventions, it is the consistent
implementation of all measures within the bundle which
ensures the success of the bundle
•  standardization of postoperative care delivery improves
not only efficiency but also patient and work safety

•  must focus on specialty specific needs and variables
(those with high SSI rates) because there is a plateau
performance level where institutions will start to see
diminishing returns for resources utilized
•  coordinated approach among multiple providers across
the entire episode of care using institution-specific data
and standardized interventions can result in sustained
reductions in colorectal SSIs

Successful SSI reduction efforts require the following facets
–  engaged front-line personnel in the context of a
strong safety culture
–  accurate outcomes measurement
–  fiscal and logistical commitment of health care
institution to cover staff time, effort, and
consumables

Revisiting the SSI Bundle of Care:
it works !!!!!
Domingo S. Bongala, Jr., MD, FPSGS, FPCS, FACS

Surgical Site Infection (SSI)

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