Decreasing orthopaedic surgical site infections: a new perioperative protocol.
Surgical site infections (SSIs) are a complication following orthopaedic surgery. It is estimated that between 300,000 and 500,000 SSIs occur each year in the U.S., and following orthopaedic surgery, the incidence can vary between 0.7% and 7.9% based on numerous variables. (1, 2) Risk factors related to the patient, such as immunodeficiency, hyperglycemia, and obesity, and those related to the procedure itself, such as anatomic location and extent of soft tissue exposure, represent variables that have a significant impact on the development of SSIs and are often not modifiable by the surgeon. However, the patient's management during the perioperative period, when the patient is exposed to pathogens responsible for SSIs, is directed by the surgical team and is a time when prophylaxis against SSIs can be most effective.
To our knowledge, there is a relative paucity of literature regarding prophylactic perioperative measures that translate clinically into decreased SSI rates, despite widespread national efforts to optimize the management of patients during this time. For example, the Surgical Care Improvement Project (SCIP) was developed and adopted in 2005 as a series of protocols, or measures, supported by research attesting to their efficacy, designed to reduce surgical complications by addressing various discrete elements of perioperative patient care. Six of the 20 measures address SSI prevention, including the three "Core Measures" that standardize prophylactic antibiotic selection, timing, and dis continuation postoperatively. (3-5)
The development of prophylactic SSI protocols, such as those established by SCIP, represent an effort to optimize and standardize the care of patients during the crucial perioperative period that is effectively under control of the healthcare team. Even as publicly reported and widely-adopted measures SCIP protocols have been shown to be effective, but only address a small portion of the management of the patients in the perioperative period and are not adhered to its entirety a majority of the time. As a result, it is uncertain as to which measures or combinations of measures have the greatest impact on reducing SSIs, and it has been proposed that several other issues not addressed by SCIP protocol are involved. (6-11)
Additional efforts are being made to identify variables during the perioperative period which are associated with surgical site infections and to further develop protocols, such as the one presented in this paper, to decrease the incidence of SSIs and their associated morbidity and mortality. At our institution, we sought to determine the effect of a series of low-cost, non-invasive perioperative measures on the rate of SSIs in our patient population. Our primary outcome measure was clinical identification of SSI by two fellowship-trained orthopaedic surgeons post-operatively for a three-month period before and after our protocol was initiated. We hypothesized our measures would decrease the overall rate of SSIs in our community hospital performing mostly (>90%) arthroscopic, outpatient orthopaedic surgical procedures.
MATERIALS AND PROTOCOL
With the assistance and input from the entire surgical team, we identified several areas representing potential breaches of perioperative sterility modifiable by the surgeon and healthcare team in the preoperative or intraoperative period. The following six measures were adopted and instituted:
1. Patients are given an 8 oz. bottle of Hibiclens antimicrobial soap at the pre-operative visit and were instructed to wash the operative extremity with half of the bottle the night before surgery and with the other half on the morning of surgery.
2. Clipping of hair from the operative site was performed and wiped clean with alcohol in the outpatient surgery area prior to entering the operative theater.
3. Following standard skin preparation and draping, consisting of 70% isopropyl alcohol scrub and Chloraprep, the operative site was prepared a second time with Chloraprep and allowed to dry before incision.
4. After final skin preparation and draping was completed, every member of the surgical team was to change outer gloves.
5. All equipment which would be needed before the case began was predicted and confirmed with the surgical team and implant representatives to minimize flash sterilization of instruments.
6. All surgical team members were required to change into clean scrubs provided in the operative area before entering any case.
After our protocol was designed and implemented, we recorded the incidence of infection for all cases performed in two-month periods before and after the intervention, for a total of 139 and 159 cases, respectively. The cases performed during the study period were primarily arthroscopic shoulder and elbow procedures (>90%). Our indications for surgery with regard to patient selection and nature of the procedure did not differ during these time periods, though specific procedural details and patient characteristics were not recorded in this retrospective study. Both before and after the implementation of our protocol, our institution was compliant with the nationally instituted SCIP protocol, especially with regard to antibiotic administration and timing.
Outcome Measures and Statistical Analysis
Monitoring of SSI before and after implementation of the perioperative protocol was performed by two fellowship-trained orthopaedic surgeons by direct examination of patients' wounds during follow-up visits to clinic. Criteria for diagnosis of SSI was based on CDC definitions of Superficial Incisional SSI, Deep Incisional SSI, and Organ/Space SSI through a follow-up period of three months.
Proportions of SSIs before and after adoption of the protocol were compared using Pearson's [chi square] test. All analyses were conducted using Statistical Analysis System (SAS) (SAS Institute, Version 9.3, Cary, NC,).
There were a total of 312 cases performed during the months of investigation with 153 performed between May 1,2012-June 30, 2012, and 159 performed from August 1, 2012-September 31, 2012. A one-month period was allowed for adoption of the protocol. Fourteen cases of SSIs were identified in the months prior to the implementation of our protocol, and no SSIs were identified in the subsequent two months after the implementation of our protocol. Following adoption of the protocol, incidence of SSIs fell significantly from 9.1% to zero (14 vs. 0, Pearson's [chi square] statistic = 15.2 on one degree of freedom, p < 0.0001).
Of the 14 patients who developed an infection, patient ages ranged from 35-69 years, five male and nine female, whose index procedures were performed either arthroscopically (7 patients) or open (7 patients). Thirteen of these procedures involved the shoulder or elbow, and one involved the knee. Seven of the infected patients required at least one reoperation, and seven resolved with a short course of oral (PO) antibiotics. Details of each patient, index procedure, and type of SSI are summarized in Table 1.
SSIs remain one of the most costly and devastating complications associated with orthopaedic surgery. New evidence suggests perioperative risk factors are significantly, if not primarily, responsible for the majority of these complications and many are within our control. (1) The strength of our study is its focus on solely orthopaedic patients at a single institution, using an inexpensive, non-invasive prophylactic protocol with the primary outcome measure as incidence of SSIs. There are relatively few other studies which examine the effect of improved perioperative protocol on the incidence of infection in a large group of patients. The benefit of our study, in the literature, is to combine what many studies have elucidated as possible modifiers of operating room sterility and translate them clinically into a method of preventing SSIs.
In order to address our problem as a surgical team, we began by taking steps that require involvement of all operating room personnel to promote awareness and compliance with our goals. Upon entrance to the operative area, all team members are required to change into a scrub suit laundered and issued by our institution in the locker room areas. Although no studies have specifically documented an association between this practice and SSIs, we believe it is logical that outside scrub suits could serve as a carrier of outside contaminants into the operative theater. (12,13) Efforts were also made to decrease traffic and open door time in the operating room, as studies have shown the microbial level in operating room air is directly proportional to the number of people moving about in it, potentially through skin squames, dust, lint, and respiratory droplets. (14,15)
Studies have shown operating room sterility and behavior can have the most profound effect on infection rate, and the surgeon should be aware that this process begins in the preadmission stage of surgery. The concept of preadmission anti-sepsis has been studied for some time, and in a 1999 CDC and Prevention Hospital Infection Control Practices Advisory Committee document, Guideline for the Prevention of Surgical Site Infection, it is stated, "A preoperative antiseptic shower or bath decreases microbial colony counts. In a study of >700 patients who received two pre-operative antiseptic showers, chlorhexidine reduced bacterial colony counts nine-fold (2.3 x 10A2 to 0.3), while povidone-iodine or triclocarban-medicated soap reduced colony counts by 1.3-1.9 fold, respectively." (12) However, as convincing these numbers might be, others argued this practice did not translate into a reduction of SSIs. (16) Several subsequent clinical studies seemed to support this notion; however, more recent investigations have proven the effectiveness of preadmission skin antisepsis in reducing bacterial skin surface colonization and SSIs when standardization methods were used (specific and detailed timed application instructions were given to the patient). (17-19) Our practice has incorporated this step in maximizing antisepsis by giving the patient one 8 ounce bottle of Hibiclens (4.0% CHG; MoInlycke Health Care; Norcross, GA) with detailed application and timing instructions.
Another aspect of our protocol involved with pre-operative antisepsis includes the best practice of hair removal from the operative extremity. There is no evidence in the literature to support hair removal by any means prior to surgery; however, surgeons often still perform hair removal when it is felt to interfere with or have the potential to grossly contaminate the surgical field. (12,20) When deemed necessary, there are data to support the safest method of hair removal. In terms of method, shaving with a razor should be avoided as it is thought that microscopic cuts in the skin provide foci for bacterial proliferation. One study demonstrated that SSI rates in patients shaved with a razor
were 5.6% compared to 0.6% of those who had hair removed by depilatory or had no hair removed at all. (21) Clipping of hair using an electric razor is thought to avoid the complications associated with shaving, and should be performed immediately prior to surgery. (12) Compared to clipping or shaving the night before surgery, patients who were clipped immediately prior to surgery showed a significantly decreased risk of SSIs (SSI rate immediately before = 1.8% versus night before = 4.0%). (21) When the surgical team decides pre-operative hair removal is necessary, it is performed in the same-day surgery area with clippers and wiped clean with alcohol before transport to the operating room. This method reduces patient time under anesthesia, as well as preventing collection and disposal of loose hair causing minor breaches in sterility in the operating theater.
Many factors in the operative theater itself can also contribute to minor breaches in sterility before and after the patient arrives, including air quality, traffic, exchange of team members, and number of persons scrubbed. (22) While many of these factors may be out of the surgeon's control on a case-by-case basis, one aspect of the operative environment that we chose to focus on is also one of the most logical--ensuring the sterility of our instruments and implants. This is intimately involved with meticulous surgical planning to predict and confirm all equipment that may be needed for a case. The Association for the Advancement of Medical Instrumentation (AAMI) has revised the term "flash sterilization" as "the process for steam sterilization of patient care items for immediate use." The AAMI does not recommend this process for implantable equipment, frequently used in orthopaedic surgery, and should not be used for convenience or as an alternative to purchasing additional equipment. (22) We furthered our efforts to plan for all equipment which might be needed for a case and communicate these plans with our surgical technicians and implant representatives.
Once in the operative theater, two more additional steps were taken to maintain antisepsis. Skin preparation is performed in the usual fashion, which at our institution involves wiping the operative extremity with 70% isopropyl alcohol followed by application of Chloraprep (70% isopropyl alcohol/2% CHG; CareFusion Corporation; Rolle, Switzerland), the combination of which has been shown to be most effective at reducing staphylococcal skin flora at the operative site compared to iodine solutions. (23) After the implementation of our new protocol, we performed a second skin prep with Chloraprep after final draping. In addition to addressing any major or minor contamination introduced during the draping process, the repeat application may be useful for any areas of skin where CHG may not have been applied at concentrations sufficient to inhibit or kill surface flora, as its effect on bacteria is dependent on skin surface concentration. At low concentrations, the cationic molecules of CHG bind to the negatively charged components of the bacterial cell wall, altering the osmotic equilibrium of cell with a resultant inhibition of growth and a bacteriostatic effect. The agent becomes rapidly bactericidal at high concentrations, as the cytoplasmic contents are precipitated, leading to cell death. (24,25) Two benefits of CHG in comparison to other skin, such as surface antiseptics are its accumulative and residual activity on the skin, such repeat applications result in higher surface concentrations, leading to increased bactericidal activity. (16) Finally, after all draping is completed, we instituted a policy which every surgical team member change outer gloves prior to incision (every member is always double gloved as an additional protective barrier for both the patient and surgeon). We are not aware of any published data recommending the specific timing and frequency of glove changes to decrease SSIs, but we find it logical that the draping process could result in unrecognized contamination. The possibility of transfer of contaminants to the wound and instruments can easily be prevented by a glove change prior to incision.
We recognize there are several limitations of our study, despite its clinically relevant contribution to our practice. We are aware patient-related risk factors influence the SSI rate, including obesity, diabetes, nicotine use, malnutrition, and immune status. We have not matched our two study groups of infected and non-infected patients to develop an association between these risk factors and SSI rates. Additionally, it cannot be determined exactly which individual aspects of our protocol were most effective based on our outcome measure. With regard to the primary outcome measure, a blinded party was not used to determine the presence of infection during the post-operative visits, which could possibly introduce a bias into our results. However, the study did not confirm in the face of innumerable risk factors for SSIs in orthopaedic surgery, it is possible to decrease the incidence of surgical site infections with the use of simple protocols which are relatively easy to control in the perioperative period, and propose no additional known risk to our patients. Our perioperative protocol decreases complications in our practice while allowing our entire surgical team an opportunity to understand and improve upon our results.
Evidence in the literature supports that surgeons and our perioperative practices have a profound impact on the development of SSIs. In a recent paper by Sechriest et al., investigators documented an unacceptably high infection rate after anterior cruciate ligament (ACL) reconstruction. The authors similarly used a team approach to develop an evidence-based, standardized protocol to address the problem, which resulted in a drop of infection rate from 1.96% to zero following implementation of the team's "Pathway" (26) We hope our data can also help prove current evidence in the literature regarding the development of SSIs and can be used to identify and refine shortcomings in our practice to produce clinically significant results. Our perioperative protocol remains in use at our institution, where infection has remained below 2%. Though further research is needed to determine the effect of the many variables that present risk factors in the development of SSIs during the perioperative period, it is clear many are under our control. Diligence from the entire operative team is important to optimize the care of patients during this time. Understanding perioperative risk factors, and implementing simple protocol to address them, can significantly decrease surgical site infections in an orthopaedic practice.
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Dr. Martin is an Orthopaedic Resident; Dr. O'Brien is a Clinical Professor of Orthopaedics, Chairman of Orthopaedic Surgery, and Chief of the Division of Sports Medicine; Dr. Savoie is a professor & chairman and the chief of the Division of Sports medicine; all associated with Tulane University School of Medicine, Department of Orthopaedics, New Orleans, LA.
Table 1: Summary Table of Surgical Infections before Implementation of the Protocol Age/Sex Index Procedure SSI Type Reoperation 35M Shoulder Arthroscopy Superficial No 48F Open SC Ligament Superficial No Reconstruction 52M Shoulder Arthroscopy Superficial No 47F Shoulder Arthroscopy Superficial No 58F Shoulder Arthroscopy Superficial No F* Shoulder Arthroscopy Superficial No 39M ORIF Ulna Deep Incisional Yes 74F Total Elbow Arthroplasty Organ/Space Yes 69F Reverse Total Shoulder Organ/Space Yes Arthroplasty 60F Elbow HWR, HO Takedown Deep Incisional Yes 51M ORIF Clavicle Deep Incisional Yes F* Shoulder Arthroscopy Superficial No 43M Knee Arthroscopy Organ/Space Yes 59F Total Elbow Arthroplasty Organ/Space Yes * Age was not found for this patient.
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|Author:||Martin, Murphy P., III; O'Brien, Michael J.; Savoie, Felix H., III|
|Publication:||The Journal of the Louisiana State Medical Society|
|Date:||Jul 1, 2016|
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