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



Intervention appropriate timing of antibiotics choice of antibiotics discontinuation of prophylactic antibiotics within 24 hours Use of clippers Postoperative normothermia



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



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)



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



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



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

Cohort (n = 559) colorectal surgeries 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





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

Cohort (n = 625) colorectal surgeries 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


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


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



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



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

Cohort (n = 602) colorectal surgeries 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



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 %



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



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



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





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)



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



- 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



PRISMA Diagram



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



-  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


Forest Plot



-  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)

Healthcare