Running head: DECREASING SURGICAL SITE INFECTIONS Decreasing Surgical Site Infections Deanna Haxton University of South Florida 1 DECREASING SURGICAL SITE INFECTIONS 2 Abstract Clinical Problem: Patients undergoing surgery are at risk for developing surgical site infections. Post-operative infections increase costs of hospital care and prolong the length of hospitalization in surgical patients (Edminston, Okoli, Graham, Sinski, & Seabrook, 2010). Objective: To evaluate if patients who received pre-surgical skin cleansing with chlorhexidine based products have a lower risk of developing post-surgical infections. An exhaustive search was completed using PubMed, CINAHL, and Ovid to identify peer reviewed randomized controlled trials. Search terms used were surgical site infections, chlorhexidine, and surgical skin prep. Two randomized controlled trials and one prospective cohort study were selected and reviewed. Results: Darouiche et al. (2010) found that the chlorhexidine group had an infection rate of 9.5% compared to the povidone-iodine group at 16.1% (p=0.004). Graling and Vasalt (2013) found an overall reduction of SSI with seven infections found in the treatment group using CHG cloths and 18 infections in the historical group who did not received CHG (p= 0.01). Paocharoen, Mingmalairak, and Apisarnthanarak (2009) found a statistically significant reduction in both colonization (CI 2.15-3.55) and infection (CI 1.40-1.81) among participants in the chlorhexidinealcohol group. Conclusion: The use of chlorhexidine products reduces the risk for the development of surgical site infections. However, there are a limited number of quality studies investigating the use of chlorhexidine as a pre-surgical skin cleanser. More research is needed to determine the most affective application and concentration needed to maximize the effectiveness of chlorhexidine skin cleansing. DECREASING SURGICAL SITE INFECTIONS 3 Decreasing Surgical Site Infections Surgical site infections (SSI) occur in the United States at a rate of around 750,000 to 1 million times per year (Edminston, Okoli, Graham, Sinski, & Seabrook, 2010). As the third most common type of hospital acquired infection, SSIs contribute to 3.7 million extra days of hospital care and costs of over $1.6 billion in extra charges (Edminston et al., 2010). Edminston et al. (2010) states that the use of pre-operative skin cleansing with Chlorhexidine Gluconate (CHG) prior to standard peri-operative skin preparations will reduce the number of colony forming units on the skin and in turn reduce the risk of SSI. CHG is a known bactericidal agent. By binding to negatively changed bacterial cell walls, CHG disrupts osmotic forces and causes cell contents to leak leading to cell death (Edminston et al., 2010). Current studies have found that there are only low levels of bacterial resistance to CHG with no instances of high levels of resistance found (Edminston et al., 2010). There has been a link between the use of chlorhexidine products and the reductions of both microorganism growth and surgical site infection (Darouiche et al., 2010; Graling, & Vasaly, 2013; Paocharoen, Mingmalairak, & Apisarnthanarak, 2009). PICOT Question In adult surgical patients, how does the use of pre-surgical chlorhexidine products, compared to the use of non-chlorhexidine products, affect the rate of post-surgical site infections occurring in a one month post-surgical period? Infrastructure to Support Practice Change Tampa General Hospital supports biomedical discovery and health service delivery research by partnering with the University of South Florida as well as other academic facilities (Tampa General Hospital, 2015). To promote evidence based practice, Tampa General DECREASING SURGICAL SITE INFECTIONS 4 Hospital’s Office of Clinical Research provides a number of resources to include medical writing services, protocol guidelines, bio-statistical assistance and grants management. Once approved, infectious disease nurses will present the proposed practice change to the nursing staff on all units where pre-surgical patients are cared for. The pre-surgical checklist will be updated to reflect the current practice change and nursing staff on all post-surgical units will collect infection indicating data, in accordance with the Guideline for Prevention of Surgical Site Infection, as part of the current post-surgical assessment practices (Mangram, Pearson, Silver, & Jarvis, 1999). Literature Search CINAHL, Pubmed, and Ovid were searched using the terms surgical site infection, chlorhexidine gluconate, skin prep, and wipes or cloths. The search was limited to peer reviewed, randomized controlled trials (RCTs) published within the last five years. After difficulty finding sufficient studies, the search was expanded to include non-RCT studies with sufficient sample sizes. Literature Review Two RCTs and one prospective cohort study were selected to evaluate the use of chlorhexidine products to reduce the incidence of SSIs in adult surgical patients (Table 1). Darouiche et al. (2010) proposed an RCT to investigate if the use of chlorhexidine-alcohol during pre-operative skin cleansing would reduce the number of SSI in adult patients. A sample of 897 adults undergoing clean-contaminated surgery was divided into an experimental group of 431 participants using a chlorhexidine-alcohol scrub and a control group of 466 participants who used a povidone-iodine scrub and paint combination. The primary goal of this study was to evaluate the rate of SSI; the secondary goal was to evaluate the types of SSI. Results found that DECREASING SURGICAL SITE INFECTIONS 5 the chlorhexidine group had an infection rate of 9.5% compared to the povidone-iodine group at 16.1% (p=0.004). The strengths of the Darouiche et al. (2010) study include random assignment of participants into experimental or control groups, explanation of why subjects did not complete the study, and both participants and investigators were blinded to assigned study group. The trial follow up period of 30 days from the date of surgery was sufficient to identify the onset of SSI symptoms. Each study group had similar demographics and p values were based on Fisher’s exact test. Weaknesses include the inability to keep participating surgeons blind to study group due to color differences in the skin cleansing solution. The operating surgeons did however remain blinded until the patient was brought into the operating room. Graling and Vasalt (2013) completed a prospective cohort study to evaluate the use of CHG cloths in reducing the incidence of SSI. A total of 335 participants were placed in the treatment group and were given a 2% CHG cloth bath prior to surgery. A historical control group of 284 patients were found to meet criteria for evaluation. The primary measure of this study was the incidence of SSI with a secondary measure investigating the type of SSI divided into deep, superficial, and open space infections. Overall, a reduction of SSI was found to be statistically significant with seven infections found in the treatment group using CHG cloths and 18 infections in the historical group who did not received CHG (p= 0.01). Strengths of the Graling and Vasalt (2013) study include a large sample size, valid instruments were used to measure outcomes, and subjects were analyzed in the group to which they were assigned. The two group’s demographics were found to be similar with the exception of age and incidence of emergency surgery. The identified weaknesses are the inability to assign participants into experimental or control groups and the investigators were not blinded to the DECREASING SURGICAL SITE INFECTIONS 6 study group. Furthermore there was an interruption in the study due to a recall of CHG bath products resulting in a delay of study for several months. It is unknown how many participants dropped out of the study or for what reasons. Paocharoen, Mingmalairak, and Apisarnthanarak (2009) completed a prospective randomized trial to compare the efficacy of a chlorhexidine-alcohol scrub versus a povidoneiodine scrub and paint pre-operatively in reducing SSI and bacteria colonization. A sample of 500 participants was divided into two groups. A total of 250 participants were placed in group one and treated with povidone iodine. Group two, containing the remaining 250 participants, was treated with chlorhexidine-alcohol. All participants were adults with clean, cleancontaminated, or contaminated wounds. The primary measures were post-operative bacteria colonization and postoperative surgical wound infection. The results found a statistically significant reduction in both colonization (CI 2.15-3.55) and infection (CI 1.40-1.81) among participants in the chlorhexidine-alcohol group. Identified strengths of the Paocharoen et al. (2009) study include random assignment to a treatment group, a sufficient follow up period of 30 days from date of surgery, subjects were analyzed in the group to which they were randomly assigned, and no significant difference existed between the two groups. Weaknesses found were lack of a control group. The study was composed of two treatment groups. It is unknown if the subjects, providers, and analyzers were blinded to the study group. The study does not state if any participants dropped out of the study. Wood and Conner (2014) presented guidelines for skin antisepsis in preoperative patients. These guidelines were written to provide a framework for preparation of skin through preoperative bathing and specific application techniques. Included in these guidelines are application techniques and the selection of skin antiseptics. A systematic review of MEDLINE, DECREASING SURGICAL SITE INFECTIONS 7 CINAHL, and the Cochrane database was conducted. A total of 166 English language sources were reviewed and measured using a systematic review with evidence tables, as well as, a review of published meta-analyses. Expert consensus was used to formulate the final recommendations. In these guidelines the use of a bath or shower with an antiseptic agent is recommended. Strengths of the Wood and Conner (2014) guidelines include the use of a systematic literature review, the rating of evidence based on strength and quality with an appraisal score. Also included are potential benefits, harms and contraindications with the proposed practice changes. Weaknesses noted were the review of only English language studies which could exclude other valid sources of information. Synthesis Darouiche et al. (2010) found a statistically significant reduction in SSI of 41% in the group treated with chlorhexidine-alcohol prior to surgery (p=0.004). Graling and Vasalt (2013) found an overall a reduction of SSI in the group receiving a 2% CHG bath preoperatively (p= 0.01). Lastly, Paocharoen et al. (2009) found a statistically significant reduction in both colonization (CI 2.15-3.55) and infection (CI 1.40-1.81) among participants who were treated with chlorhexidine-alcohol pre-surgically. These studies have shown that the use of chlorhexidine products pre-surgically results in a significant decrease in SSIs. However there are a limited number of quality studies investigating this intervention. Further study is needed to identify which formulation, concentration, and application technique should be used to maximize the impact of chlorhexidine on the reduction of SSIs. DECREASING SURGICAL SITE INFECTIONS 8 Proposed Practice Change Implementing pre-operative cleansing with chlorhexidine wipes is a low risk intervention which can be done to reduce the risk for development of post-surgery site infections. Surgical patients should be bathed with a chlorhexidine containing no-rinse cloth within three hours of scheduled surgery as part of a pre-surgical cleanse. This intervention is not intended to replace the peri-operative skin preparation normally performed within the surgical suite. Change Strategy Develop a Vision for Change By building a team of stakeholders who are passionate about change, it is possible to impact a greater culture of change within the clinical environment (Melnyk & Fineout-Overholt, 2015). When introducing change it is best to focus on short term, attainable goals with only a minimal increase in labor required (Melnyk & Fineout-Overholt, 2015). By recruiting change champions in each unit and uniting them with clinical experts and the support of the administration, it is possible to increase the awareness of the need for change in pre-surgical skin preparation. Furthermore, by presenting real scenarios of complications resulting from surgical site infections that occurred at Tampa General, it is possible to stress the need for change. Roll Out Plan Tampa General Hospital currently follows the Iowa model of evidence-based practice to promote quality care. In accordance with this model, the roll out plan for this proposed practice change in pre-surgical skin cleansing will be completed as seen below. Roll Out Plan Steps Identify Triggers Definition Identify the clinical question by looking at triggers. A trigger may be identified by Timeframe Completed January 2015 DECREASING SURGICAL SITE INFECTIONS Organizational Priorities Forming a Team coming across a problem in the clinical setting or obtaining new knowledge. Identify SSI as an area of desired improvement Identify current practices regarding skin preparation Review most up to date data regarding prevention of SSI Identify the risks of SSI Identify facility priorities Consider the cost of the intervention needed Review new research available Determine if this problem is a 1 April 2015 clinical priority. Items which may be of higher priority include: How many surgical procedures does TGH complete annually What amount of income is generate through surgical procedures How do SSI impact the hospital’s ratings and patient outcomes High-Cost Procedures Is reduction of SSI a priority to TGH Form a team from 15 April 2015 stakeholders across the institution. The team will: Select and Review Research Evidence Critique Research Synthesize Available Evidence 9 DECREASING SURGICAL SITE INFECTIONS 10 Piloting a Practice Change Evaluating the Pilot Scout for motivated individuals in pertinent surgical areas Implement a small trial 1 May 2015 before rolling out procedure change to the entire institution. Collect pre-pilot and post-pilot data to be use in the next phase. Evaluate the data collected Evaluate:1 June 2015 during the pilot test and decide if the practice change should be adopted or if further modification is needed. If the pilot was a success, roll Implement: 1 August 2015 out practice changes through the help of leadership and stakeholders. Monitor results and share. 1 October 2015 Evaluating Practice Change Dissemination of results is and Dissemination of Results key. Information should be shared both inside and outside of the institution. AORN Surgical Nurses April 2016 Conference presentation The Iowa model of evidence-based practice change (Melnyk & Fineout-Overholt, 2015, p. 285). Project Evaluation Beginning in August 2015 all pre-surgical checklists will be updated to include the use of CHG no-rinse wipes three hours prior to surgery. The nurse assigned to care for each postsurgical patient will collect data in accordance with the Guideline for Prevention of Surgical Site Infection (Mangram et al., 1999). By comparing the incidence of SSIs prior to intervention with those following intervention an evaluation of the effectiveness can be made. Follow up on intervention should be completed every three months to evaluate the continued success of the proposed process change. This intervention will be considered a success if there is a decline in the incidence of SSIs of 60% after intervention. DECREASING SURGICAL SITE INFECTIONS 11 Dissemination of EBP For dissemination within the facility change champions will be identified in each unit affected by the proposed change of practice. These individuals will be an expert and point of contact for questions and concerns regarding policy change. Information regarding the change in practice will be posted in unit break areas and distributed via staff email. Furthermore the evidence supporting change will be presented to all staff during unit staff meetings. In order to disseminate information to outside hospitals and institutions the collected data will be synthesized and submitted for presentation at local conferences and for publication in scholarly journals. A podium presentation will be proposed for review at the AORN’s Surgical Nurse Conference scheduled for April 2016. During this presentation the clinical problem will be introduced and the primary purpose of the study will be reviewed. Next, the results will be presented along with critical appraisal of the evidence. The findings of the study will be presented and the possibility of future practice changes or needed research will be addressed. A poster reviewing the study and the results will be created by TGH’s social media team for presentation at the conference as well as in local and regional publications. DECREASING SURGICAL SITE INFECTIONS 12 References Darouiche, R. O., Wall, M. J., Itani, K. M., Otterson, M. F., Webb, A. L., Carrick, M. M.,…Berger, D. H. (2010). Chlorhexidine-alcohol versus povidone-iodine for surgicalsite antisepsis. The New England Journal of Medicine, 362, 18-26. doi: 10.1056/NEJMoa0810988 Edminston, C. E., Okoli, O., Graham, M. B., Sinski, S., & Seabrook, G. R. (2010). Evidence for using chlorhexidine gluconate preoperative cleansing to reduce the risk of surgical site infection. Association of Perioperative Registered Nurses Journal. 92, 509-518. doi: 10.1016/j.aorn.2010.01.020 Graling, P. R., & Vasaly, F. W. (2013). Effectiveness of 2% CHG cloth bathing for reducing surgical site infections. Association of Perioperative Registered Nurses Journal. 97, 547551. doi: 10.1016/j.aorn.2013.02.009 Mangram, A. J., H oran, T. C., Pearson, M. L., Silver, L. C., & Jarvis, W. R. (1999). Guideline for prevention of surgical site infection. Infection Control and Hospital Epidemiology. 20,247-278. Retrieved from http://www.cdc.gov/hicpac/pdf/SSIguidelines.pdf Melnyk, B. M., & Fineout-Overholt, E. (2015). Evidence-Based Practice in Nursing & Healthcare (3rd ed.). Philadelphia, PA: Wolters Kluwer Lippincott Williams & Williams. Paocharoen, V., Mingmalairak, C., & Apisarnthanarak, A. (2009). Comparison of surgical wound infection after preoperative skin preparation with 4% chlorhexidine and povidone iodine: A prospective randomized trial. Journal of the Medical Association of Thailand, 92(7), 898-902. Retrieved from http://www.mat.or.th/journal/files/Vol92_No.7_898_5146.pdf Tampa General Hospital. (2015). About OCR. Retrieved from https://www.tgh.org/ocrabout.htm DECREASING SURGICAL SITE INFECTIONS Wood, A. & Conner, R. (2014). Guideline for preoperative patient skin antisepsis. Retrieved from National Guideline Clearinghouse website: http://www.guideline.gov/content.aspx?id=48860&search=aorn 13 DECREASING SURGICAL SITE INFECTIONS 14 Table 1 Literature Review Reference Darouiche, R. O., Wall, M. J., Itani, K. M., Otterson, M. F., Webb, A. L., Carrick, M. M.,…Berger, D. H. (2010). Chlorhexidinealcohol versus povidone-iodine for surgical-site antisepsis. The New England Journal of Medicine, 362, 1826. doi: 10.1056/NEJMoa0 810988 Graling, P. R., & Vasaly, F. W. (2013). Effectiveness of 2% CHG cloth bathing for reducing surgical site infections. Association of Perioperative Registered Nurses Journal. 97, 547551. doi: 10.1016/j.aorn.201 3.02.009 Paocharoen, V., Mingmalairak, C., & Apisarnthanarak, A. (2009). Comparison of surgical wound Aims Design and Measures To determine Prospective if randomized chlorhexidine- clinical trial. alcohol or Microbiologic povidonesamples were iodine will be taken in those more effective suspected of at preventing infection. surgical site infections. Sample To determine if the use of 2% CHG norinse cloth bath performed within three hours of surgery will reduce the number of SSIs. Prospective cohort study. Infection was determined by the Centers for Disease Control and Prevention operation definitions. 619 adult surgical patients: 335 in the 2% CHG cloth group and 284 in the no bath group. CHG group: 7 infections No bath group: 18 infections (p= 0.01). To determine the efficacy of chlorhexidine over povidoneiodine in reducing Prospective randomized trial. Infection determined by skin culture, purulent drainage and 500 adult patients with cleancontaminated or contaminated wounds. The Chlorhexidine alcohol group Chlorhexidine group skin colonization reduced 31.2% and povidone iodine group reduced 14.4% 849 adult surgical patients: 409 treated with chlorhexidinealcohol, 440 treated with povidoneiodine. Outcomes/ Statistics Chlorhexidine group had an infection rate of 9.5%. Povidone-iodine group infections occurred in 16.1% (p=0.004) DECREASING SURGICAL SITE INFECTIONS infection after bacterial preoperative skin growth and preparation with SSIs. 4% chlorhexidine and povidone iodine: A prospective randomized trial. Journal of the Medical Association of Thailand, 92(7), 898-902. Retrieved from http://www.mat.or. th/journal/files/Vol 92_No.7_898_514 6.pdf surgeon’s judgement. 15 contained 91 females and 159 males. The povidone-iodine group contained 122 females and 138 males. (CI 2.15-3.55). There were five SSI in the chlorhexidine group and eight SSI in the povidone-iodine group (CI 1.401.81).