Wini Hayes, PhD, RN, ANP President and CEO, Hayes, Inc AHVAP Conference

Transcription

1 Wini Hayes, PhD, RN, ANP President and CEO, Hayes, Inc AHVAP Conference Copyright 2014 Winifred S. Hayes, Inc. Describe and illustrate the process used to define the clinical problem to be resolved and the current standard of care ( care bundles ). Describe how high-risk patient groups, providers, settings, and procedures are linked to surgical site infection (SSI) prevention. Define and discuss methods used to assess the adequacy of current standards of care/care bundles in the prevention of SSIs in both research settings and the participant institution. Describe, discuss, and utilize evidence evaluation methodology to assess clinical studies that have been performed to evaluate the safety and efficacy of various health technologies used to prevent SSIs. Building on these health technology assessments within the clinical context of care in a real-world population, describe and provide rationale for the recommendations that would arise from this approach to SSI prevention. 17% of all hospital-acquired infections (HAIs) are SSIs; 2nd most common HAI, second to urinary tract infection (UTI). Approximately 300,000 SSIs per year in U.S.; 2% to 5% of those undergoing inpatient surgery. Prolong hospital stays by 7 to 10 days. 3% mortality associated with SSIs; 75% of deaths are directly due to infection. $3.5 to $10 billion estimated annual costs attributed to SSIs in the U.S. SSI rates vary widely but are as high as 30% plus; outpatient rates and costs are underreported. 1

2 Endogenous Patient flora Skin Mucous membranes Gastrointestinal (GI) tract Seeding from a distant focus of infection Exogenous Surgical personnel (surgeon and team) soiled attire Breaks in aseptic technique Inadequate hand hygiene OR physical environment and ventilation Tools, equipment, materials brought to the operative field Staphylococcus aureus 30.0% Coagulase-negative staphylococci 13.7% Enterococcus spp. 11.2% Escherichia coli 9.6% Pseudomonas aeruginosa 5.6% Enterobacter spp. 4.2% Klebsiella pneumoniae 3.0% Candida spp. 2.0% Klebsiella oxytoca 0.7% Acinetobacter baumannii 0.6% N=7025 Hidron AI, et.al. Infect Control Hosp Epidemiol. 2008;29: Hidron AI, et.al. Infect Control Hosp Epidemiol. 2009;30: (erratum) 2

3 Challenges in detecting SSIs Lack of standardized methods for post discharge/outpatient surveillance Increased number of outpatient surgeries Shorter postoperative inpatient stays Antimicrobial prophylaxis ineffective Increasing trend toward resistant organisms may undermine the effectiveness of existing recommendations for antimicrobial prophylaxis Culture of safety and quality (compliance w/ bundles and checklists) Surgical procedure Procedure time duration (short versus long is better) Surgical team s skill and adherence to aseptic practices Events in the OR: Door openings, chatter, noise, etc. (OR discipline) Skin prep: Bathing, hair removal w/ clippers, surgical prep Core body temperature (normothermia) Preoperative antibiotic prophylaxis and antibiotic stewardship Wound sealants, dressings, protectors, and management Nasal bacterial decolonization of MRSA carriers Perioperative glycemic control Supplemental oxygen (operative and postoperative) Intraoperative fluid restriction Minimally invasive surgery Omit mechanical bowel prep 3

4 Core strategies High levels of scientific evidence Demonstrated feasibility Supplemental strategies Some scientific evidence Variable levels of feasibility Yes, sometimes Culture of safety and quality Compliance: Gaining buy in and adherence Audits: Measuring compliance with the care bundle Is there a best number of bundle elements? How do you select or build a care bundle? How does a checklist fit in? Bundle variation by surgical procedure? 1. Bundles may need to vary somewhat based on the operative procedure. Graf K, et al. Decrease of deep sternal surgical site infection rates after cardiac surgery by a comprehensive infection control program. Interact Cardiovasc Thorac Surg. 2009;9(2): Added MRSA screening and bacterial decolonization measures, changing surgical gloves after sternotomy and sternal wiring, leaving wound primarily covered for 48 hours and new bandaging techniques. Deep sternal surgical site infection (DSSI) decreased from 3.61% to 1.83%. Also saw positive correlation with extubation on the day of surgery. 4

5 2. Care bundle compliance is critical to success. Crolla RM, et al. Reduction of surgical site infections after implementation of a bundle of care. PLoS One. 2012;7(9)9:e Care bundle for colorectal surgery included 4 elements: perioperative antibiotic prophylaxis, hair removal with clippers, perioperative normothermia, and discipline in the OR (root cause analysis of door openings and which changes to eliminate coffee breaks, missing equipment, social interruptions, etc.). Also, fostering a culture of safety (e.g., correcting each other) and communicating results. Bundle compliance climbed from 10% to 80% from 6/ /2011 (P=0.001) colorectal procedures performed with an SSI rate of 19.5% (8.1% superficial SSIs, 11.5% DSSIs) during study period. 36% drop in SSI infection rate in last study year. Figure 2. Annual changes in the surgical site infection (SSI) rate and bundle compliance and the 95% confidence interval. Footnote: 2008 was taken as the reference year for SSI and the relative changes after adjustment for confounding variables are provided. doi: /journal.pone g002 5

6 Figure 3. Kaplan-Meier curve of 6 months mortality in patients with and without a surgical site infection (SSI). doi: /journal.pone g003 Other factors associated with lower SSI rates: Laparoscopic versus open procedures Higher versus lower number of surgeries by surgeon Lower ASA score and/or wound class Elective versus non-elective procedures Shorter versus longer duration of procedures (< 3 hours) 6

7 3. Preventing MRSA SSIs tied to screening and bacterial nasal decolonization. Schweizer M, et al. Effectiveness of a bundled intervention of decolonization and prophylaxis to decrease Gram positive surgical site infections after cardiac or orthopedic surgery: systematic review and meta analysis. BMJ. 2013;346:f studies included. What this meta analysis tells us Among patients undergoing cardiac or orthopedic surgery: Nasal decolonization w/ mupirocin ointment was protective against Gram-positive SSIs. Preoperative prophylaxis w/ anti-mrsa antibiotics when given to all patients was not protective against Gram-positive SSIs. A bundle that included nasal decolonization and anti-mrsa prophylaxis for MRSA carriers was significantly protective against Gram-positive SSIs. 4. There are host- and procedure-related modifiable and non-modifiable risk factors. SSI care bundles address many of these risk factors. For orthopedic procedures, these modifiable risk factors include: obesity, current smoking, hematocrit 36, elevated serum glucose, nasal carriage of S. aureus, operative blood loss 1 liter, longer procedure times, suboptimal timing of prophylactic antibiotics, 2 participating surgical residents, spinal procedure via the anterior/ posterior or posterior approach. Non-modifiable orthopedic procedure risk factors for SSI include: diabetes, male sex, rheumatoid arthritis, ASA score 3, recent weight loss, dependent functional status, metastatic cancer, admission from a healthcare facility, previous infection at site, prolonged wound drainage, low # procedures performed at hospital and/or by surgeon. Guide to the Elimination of Orthopedic Surgical Site Infections. An APIC Guide, ISBN:

8 Anthony T, et al. Evaluating an evidence-based bundle for preventing surgical site infection: a randomized trial. Arch Surg. 2011;146(3): Care bundle versus standard care for 211 patients undergoing elective transabdominal colorectal surgery. Bundle included: omission of mechanical bowel prep, preop and intraoperative warming, supplemental oxygen during and immediately following surgery, intraoperative IV fluid restriction and use of a surgical wound protector. All elements individually supported by high-level evidence. SSI rate in the bundle group at 30 days postop was 45% and in the control group 24%, w/ most of the difference as superficial infections. Compliance w/ bundle elements was 94%. The most obvious reason for an evidence-based bundle s failure is noncompliance with the bundle. However, with the Anthony et al. study, compliance was high. So what are the possible explanations? Some recent studies seem to indicate that omitting bowel preps and supplemental oxygen may not reduce SSIs (bundle elements). Uncertain about size of contribution of individual measures/elements. Several risk factors for SSIs were imbalanced in the 2 study groups. Study population appears not to be typical of the general population and therefore study not generalizable. Focus on compliance on the bundle may have been a distraction from other critical elements impacting outcomes. 8

9 Where Do We Start? SSI rates by surgeon and surgical team SSI rates by surgical procedure MRSA SSI rates SSI rate variation by practices (care bundle elements) and changes in workflow practices SSI rates by care unit Trends over time SSI rates by patient population subgroups Comparisons across the health system and to national benchmarks Address preoperative, intraoperative, and postoperative elements. Consider care bundle elements specific to the surgical procedure and patient-specific risk factors. Consider SSI trends and compliance measures. Emphasize elements supported by high level of evidence. Validate that bundles are up to date and new evidence-based elements are added, if warranted. 9

10 Preoperative shower (4% chlorhexidine) Hair removal (clippers), if necessary MSRA screening MRSA carrier nasal decontamination No mechanical bowel prep Timely/appropriate antibiotic prophylaxis No hand jewelry, artificial nails/polish, clean scrubs; complete OR setup; hand washing Antiseptic skin prep (4% chlorhexidine) Maintain homeostasis (normothermia, IV fluid restriction/management; serum glucose control; supplemental oxygen for non intubated patients evidence inconsistent) As indicated, readminister antibiotic for procedures 3 hours OR discipline (limit/eliminate door opening, changing staff, social chatter, loud noise) Wound sealant/dressing Primary wound dressing in place 48 hours Maintain homeostasis Aseptic dressing changes Wound surveillance, including post discharge Hand washing 10

11 What are the elements in your surgical bundles? How do bundles vary by procedure type? Do your OR staffs use a surgical safety checklist? Do you report SSI rates by surgeon, type of procedure, and other high-risk grouping? What action does your health system take? How do you promote and measure compliance? How do you evaluate the effectiveness of your bundles, assuming bundle compliance? Determine the effectiveness of your current approaches. What are your SSI rates/trends? What measures of compliance have you operationalized? What do these data indicate? Take 5 minutes to jot down your answers 11

12 If your OR staff is not compliant with the SSI care bundle, it will be difficult to accurately evaluate the true impact of a new prevention element. In spite of this, your organization may choose to pursue the addition of a new silver bullet. So. Conduct an evidence-based value analysis (EBVA) of the proposed care bundle element. Evidence Information Data Perception and Experience Opinion and Consensus 12

13 Something that is accepted as proof, truth, or demonstrates cause and effect.* Findings (evidentiary date) generated as a result of formal research studies and clinical trials. * The quality of evidence is dependent on a number of factors, which will be discussed later. High-quality evidence is necessary to support cause-and-effect conclusions. Measurements or statistics used as a basis for reasoning, discussion, or calculation. Information output by a sensing device or organ that includes both useful and irrelevant or redundant information and must be processed to be meaningful. Information in numeric form that can be digitally transmitted or processed. The communication or reception of knowledge or intelligence. Knowledge obtained from investigation, study, or instruction. 13

14 The way you think about or understand someone or something. The way that you notice or understand something using one (or more) of your senses. Discernment, insight, understanding, discrimination. A view, judgment, or appraisal formed in the mind about a particular matter. A belief stronger than impression and less strong than positive knowledge. A formal expression of judgment or advice by an expert. A general agreement about something. An idea or opinion that is shared by all of the people in a group. 14

15 Direct observation of or participation in events as a basis of knowledge. Fact or state of having been affected by or gained knowledge through direct observation or participation. Informa(on Data EVIDENCE Opinion Experience and Percep(ons What is evidence-based value analysis (EBVA)? What is the value proposition for EBVA? How does the EBVA process work? How would we want to apply EBVA in considering the addition of a health technology to a care bundle? 15

16 Using evidence along with other data and information to evaluate a health technology and its role in providing essential functions that solve clinical problems or needs. Clinical trial and other research data Patient-registry data Financial, administrative, and operational data Clinical data Value analysis professionals use these various sources of evidence, data, and information along with experiences and opinion to evaluate clinical and comparative effectiveness, patient safety, operational impact, and costs of the health technology within the context of the care continuum or care bundle. 16

17 HOW DOES THE EBVA PROCESS WORK? Begin with a clear understanding of the questions that need to be answered. What is the problem this EBVA project needs to solve? Define the context of use or care bundle and the stakeholders to be included in the EBVA process. Does the clinical evidence support the use of this technology (safety/effectiveness)? If yes, for all or specific procedures? If yes, for all or specific populations? Is the reduction in SSIs clinically significant? Has this technology been evaluated in facilities that have an effective care bundle? 17

18 Develop and execute the search strategy aimed at answering your questions and identifying applicable research evidence and other important data and information. Take the next 10 minutes and develop in writing your search strategy. What sources and databases would you search? What search terms would you use? How would you confirm the effectiveness of your search? How would you identify and select the best available evidence? Discuss your plan with the colleagues at your table. Gather, organize, and analyze other relevant data and information. SSI rates and trends Clinical and financial data Current clinical practice patterns Performance data regarding health technology(ies) currently in use Stakeholders feedback and opinion Manufacturer information Clinical context of use/care bundles 18

19 Take 10 minutes and write down the internal data you will want to collect and analyze. Describe what you will do with these data. How important to your project will it be to have standardized definitions of SSIs and standardized ways of conducting surveillance and reporting the results? How will you approach the issue of SSI care bundle compliance? Discuss your plan with your colleagues. Select a reporter to share your approaches with the larger group. (10 minutes) Review the results of your searches and characterize the quantity and quality of the applicable research studies. Select the best available evidence for full-text review. Review other sources of data and information; pull relevant documents (e.g., government agencies and professional association s care bundles, clinical guidelines, and position statements). CRITICALLY APPRAISE THE EVIDENCE What is the level of evidence to support the claims made for this technology? What has been done to ensure lack of bias in the trial results? Is there evidence of impact on clinically relevant outcomes or only on surrogate outcomes? 19

20 Is the evidence statistically significant, and is the size of the impact clinically significant? Is there evidence to show that this would be effective in our patient population under our conditions? What does the evidence tell us about comparative effectiveness? Briefly define what the terms in the prior 2 slides mean Discuss within your group (10 minutes) Report back to the larger group Research design Research execution Research statistics and qualitative analysis Strength of conclusions, generalizability, and replication Funding sources, intentional bias, and conflicts of interest 20

21 Observational or experimental design Assignment of subjects to treatment (groups) Prospective versus retrospective Controlling unintentional bias and confounding variables: Blinding, randomization, stratification, placebo/ Hawthorne effect Patient outcomes versus surrogate outcomes Study size and power Is it safe? Is it efficacious (under ideal conditions)? Is it effective (under routine conditions)? For what specific patient and clinical indications? Does it improve clinical and quality-of-life outcomes? How does it compare with competing or alternative technologies? Is it cost-beneficial and/or cost-effective? 21

22 Is the test reliable and accurate? Does it contribute to an accurate diagnosis? Does it replace other diagnostic technologies or influence the subsequent use of diagnostic studies/tests? Do test findings influence clinical decisions? Are health outcomes ultimately improved? Does use of the technology improve the cost-effectiveness of the healthcare provided compared with alternative approaches? How were subjects recruited and actually assigned to treatment groups? For diagnostic/screening tests, how were test reliability, sensitivity, specificity, and predictive value determined and compared with the current diagnostic standard? How objectively were outcomes measured? By whom? Was the length of follow-up adequate for the condition being studied/treated? What proportion of subjects were lost to follow-up or dropped out of the study? Did controls, such as matching, randomization, sham procedures and blinding, work? If meta-analysis was the research design, were included studies outcomes appropriately comparable and were studies of comparable quality? Was the study funding source disclosed? Did study article authors have full access to all study data? Were all potential/actual conflicts of interest disclosed? Was the study published in a peer-reviewed journal? Were expected research findings adequately discussed in the study report? Were all strengths and limitations noted? Did conclusions correlate with the quality of evidence? 22

23 Read the research report, Lavu H, et al. Perioperative surgical care bundle reduces pancreaticoduodenectomy wound infections. J Surg Res. 2012;174(2): Critique its study design and execution. What are its strengths and limitations? What conclusions can you draw from its findings? What level of evidence characterizes this report? Discuss within your group; report to the group at large. Synthesize and summarize findings Evidence tables are a useful way to communicate and summarize studies design, size, subjects, interventions, outcomes and strengths and limitations Comparison tables allow display of product features, impact, strength of evidence, etc. Authors, study dates and settings are noted 23

24 State conclusions, recommendations and/or options for consideration Provide rationale Provide references Develop utilization protocol/guideline Chlorhexidine Gluconate 4% for Prevention of Surgical Site Infection Is preoperative whole-body bathing with chlorhexidine gluconate 4% prior to surgery effective in the prevention of surgical site infection? A total of 5 randomized controlled trials and 1 large nonrandomized comparative study were identified. There is conflicting evidence from the available studies evaluating the efficacy of whole-body bathing with chlorhexidine 4% for preventing SSI. Two randomized controlled trials indicated that washing with chlorhexidine significantly reduced the incidence of SSI. Data from one trial making this comparison showed a statistically significant reduction in SSI when whole-body washing (1.7%) was compared with placebo (4.6%) and with partial washing of the surgical site (4.1%). Another randomized controlled trial showed that the incidence of infection was reduced after whole-body washing with chlorhexidine, compared with bar soap and placebo (9.0%, 12.8%, and 11.7%, respectively). However, evidence from the remaining studies, including well-designed and well-conducted randomized controlled trials, showed no significant benefit of whole-body washing compared with regular soap or placebo for preventing SSIs. 24

25 Whole-body washing with chlorhexidine appears to safely lower skin bacterial colonization Insufficient proof that the routine use of this protocol will lower rates of SSI, or have a positive effect on patient outcomes such as mortality or hospital stay. Decision to adopt or to continue use of a whole-body chlorhexidine washing protocol or another preoperative washing regimen should be made on a hospital-byhospital basis as part of a comprehensive infection control program to improve patient safety. Are there any cost savings? Mean attributable costs of SSI have been estimated at a low of $10,443 per infection in 2005 dollars to a high of $25,546 per infection in 2002 dollars. The aggregate costs attributable to an estimated 290,485 cases of SSI, using the 2007 Consumer Price Index, range from $3.5 to $10 billion for inpatient hospital services (Scott, 2009) Therefore, if medicated detergents were proven to reduce the incidence of severe infection, preoperative washing with these agents would likely be cost saving. What about evidence based projections? While there is little evidence to support the routine use of preoperative whole-body chlorhexidine bathing as a method to prevent SSIs, given the relatively low cost of chlorhexidine solutions compared with the cost of SSI, and the already widespread acceptance of chlorhexidine bathing, this procedure is likely to continue in those institutions where its use is already practiced. There are no known safety issues that would require the cessation of this protocol. Hayes, Winifred S. Health Technology Brief. Preoperative Whole-Body Bathing with Chlorhexidine Gluconate 4% for Prevention of Surgical Site Infection. March 22, Retrieved from: Accessed October 3,

26 Preadmission patient bathing with 2% Chlorhexidine Gluconate Cloths Does the use of 2% Chlorhexidine Gluconate (CG) in pre-operative baths reduce SSIs? Does the use of cloths impregnated with CG provide equivalent, superior or inferior benefit? What are the cost benefit implications? Quality of Evidence- Low. There are 4 relatively large retrospective beforeand-after studies and 1 smaller RCT. The overall quality of the evidence is low due to: - Lack of large, prospective controlled trials, - Differences across the studies in surgical indications and bathing regimens, - Results rest on the accuracy of patient-reported compliance. - Difficult to determine whether other factors played a role in the observed reductions in the rate of SSIs. 5 studies that evaluated the efficacy and safety of preadmission patient washing with 2% chlorhexidine cloths including 1 RCT and 4 retrospective studies. Four studies included patients undergoing elective orthopedic surgery, and 1 study included women scheduled for a cesarean section. Three studies compared standard preoperative cleansing with washing with 2% chlorhexidine cloths. One study compared povidone-iodine scrubs with the use of 2% chlorhexidine cloths, and one study compared povidone-iodine scrubs with 2% chlorhexidine cloths combined with 2% chlorhexidine 70% povidone-iodine scrubs. In the RCT (n=100), the rate of positive skin cultures was significantly reduced in patients who cleansed with the 2% chlorhexidine cloths compared with standard soap and water shower. There were no SSIs in either group during a follow-up of 2 months. Since there were no SSIs, additional study is needed to determine if reduced bacterial loads associated with chlorhexidine washing would contribute to a reduction in SSI incidence. Compliance rates were high (90% of Chlorhexidine group and 100% of Control group). 26

27 Preadmission Patient Bathing with 2% Chlorhexidine Gluconate Cloths (Sage Products Inc.) for Prevention of Surgical Site Infection CLINICAL I MPACT Published: July 27, 2013 Standard Soap and W ater 2% Chlorhexidine Cloths (Sage Products Inc.) Rate of Surgical Site Infection ( SSI) 1.7% to 2.2% 0.5% to 0.6% Si gni fi cant r educti on c ompared wi th Standard Soap a nd W ater Active Ingredients/ Properties Vari abl e a ccordi ng to brand Broad- spectrum a nti mi crobi al ; 5 00 mi l l i grams of c hl orhexi di ne per cl oth; Al cohol - a nd l atex- free Label ed for pati ent preoperati ve s ki n preparati on. Indications Contraindications None Precautions None In May 2 012, the FDA a dvi sed the manufacturer to a dd the fol l owi ng to the Di recti ons for Use i n I nfants l anguage: use wi th care i n premature i nfants or i nfants under 2 months of a ge. These products may c ause i rri tati on or c hemi cal burns. Adverse Effects None Mi nor s ki n i rri tati on Warnings FDA Approval European Medicines Agency ( EMA) Approval No s peci fi c i ndi cati ons; Use of 2 % c hl orhexi di ne c l oths a t home has been eval uated i n pati ents undergoi ng vari ous types of s urgery. In pati ents wi th known a l l ergi es to c hl orhexi di ne gl uconate or any other i ngredi ents i n thi s product In premature or l ow bi rth wei ght i nfants In i nfants r ecei vi ng phototherapy In i nfants < 2 months of a ge In pati ents undergoi ng a l umbar puncture In c ontact wi th the meni nges On open s ki n wounds As a general s ki n c l eanser Sterility Prescription No s peci fi c i ndi cati ons None For external use onl y Nonsteri l e Nonsteri l e Nonprescri pti on Nonprescri pti on Not a ppl i cabl e Not a ppl i cabl e The FDA a pproved 2 % c hl orhexi di ne c l oths for over- the- counter (OTC) use on Apri l 2 5, The FDA defi nes O TC drugs a s s afe a nd effecti ve for use by the publ i c wi thout a prescri pti on. Sage Products I nc. l i sts products for s al e i ncl udi ng the 2 % chl orhexi di ne c l oths on thei r gl obal websi te. Preadmission washing with 2% chlorhexidine wipes appears to safely lower skin bacterial colonization Insufficient proof that the routine use of this protocol will lower rates of SSI, or have a positive effect on patient outcomes such as mortality or hospital stay. Studies did not compare use of CG with and without impregnated cloths What about evidence-based projections? Despite the paucity of evidence on the efficacy of preadmission bathing with 2% chlorhexidine cloths for reducing SSIs, this practice is likely to continue in institutions as part of an integrated preoperative skin preparation protocol. The continuing use of 2% chlorhexidine cloths and other chlorhexidine products is supported by their relatively low cost, patient-friendly application, absence of serious adverse events, and the recommendations of professional guidelines stating that chlorhexidine is an effective antiseptic. This protocol has no known safety issues. Preadmission Patient Bathing with 2% Chlorhexidine Gluconate Cloths (Sage Products Inc.) for Prevention of Surgical Site Infection. Hayes Health Technology Brief. 4/9/13; Annual Review 3/21/14. 27

28 Does the use of antibiotic-coated sutures as compared with uncoated sutures reduce the incidence of SSI? Is the use of coated vs. uncoated sutures safe? Have definitive patient selection criteria been established? Coated with Irgacare MP (BASF), a pure form of tricolsan. Triclosan broad spectrum antibacterial agent that is already used in consumer products like soap, toothpaste, and deodorant for past 30 years. The coated suture slowly releases triclosan thus inhibiting bacterial colonization of such bacteria as Staphylococcus aureus Staphyloccocus epidermidis methicillin-resistant Staphyloccocus aureus methicillin-resistant Staphyloccocus epidermidis Vicryl Plus absorbed rapidly (56-70 days) Monocryl Plus absorbed at intermediate rate (91 to 119 days) PDS Plus absorbed slowest (182 to 238 days) *Triclosan-coated suture has been used for closure of the: Fascia, subcutaneous tissue, subcuticular tissue and skin 28

29 15 randomized controlled trials (RCTs) and 5 non randomized cohort studies showed the following Variety of procedures have been performed (breast, cardiac, vascular, plastic, orthopedic, abdominal, colorectal, head and neck, and cerebrospinal shunt placement). All studies compared antibiotic-coated sutures with uncoated suture. Most studies focused on a single type of surgery, although some were mixed. Primary outcome measure was incidence of SSIs Secondary measure within some studies also included complications or markers of inflammation Two comparative studies enrolled <100 patients Three RCTs did not report double-blinding Two cohort studies were retrospective Short follow-up times Three studies report use of non-coated and coated suture material in two non-overlapping time periods * Studies with double blinding of patients and assessors (to minimize risk of bias) showed conflicting outcomes. 3 reported reduction in SSIs 4 reported no effect on SSI rates The body of evidence was only moderate in quality. This quality was reduced by- Mixed results Variations in surgical procedures and patient samples Antibacterial suture manufacturer sponsored at least three studies The authors did not report the use of antibacterial sutures was part of a surgical care bundle. Hayes, Inc. Medical Technology Directory. Antibiotic-Coated Sutures. Lansdale, PA: March 11, Retrieved from: Accessed October 3,

30 Over the next 20 min. read the following article and answer the questions that follow. Charles E. Edmiston. 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. Surgery, Vol. 154, No. 1, pp Characterize the quality of the studies included in the meta analysis Are there differences in study design and execution that call into question the inclusion of some of the studies? Describe. What are the strengths and limitations of this meta analysis? Are the study authors conclusions supported? Explain briefly. Take a brief look at the 2 letters to the editor. Discuss your conclusions with your colleagues. Appoint a reporter to share conclusions with all participants. Summary Discussion How would you approach the creation of a care bundle for SSIs? What core elements would you include? What might be adjunct elements? How would you approach the evaluation of an SSI care bundle? What would you consider when a new technology is requested as an addition to the SSI care bundle or as an adjunct technology? Open Discussion 30