Research Design: Qualitative

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Surgical site infections are an ongoing problem in hospitals and surgery centers across America.  Studies have shown up to 16% of all nosocomial infections are caused directly by a surgical procedure (Harrington, 2014) and more than half of those surgical site infections are orthopedic in nature (Ercole et al., 2011).  Orthopedic related surgical infections have shown to carry higher risk than other surgical procedures due to the common use of implants and longer surgery durations greater than 90 minutes (Ribeiro, Benedita dos Santos, Bellusse, Rezende, & Galvao, 2013).  Other factors putting patients at higher risk of infection include wound contamination, skin preparation, and surgical room environment, such as how many staff members may be present during surgery (Ercole et al., 2011).  Because surgical site infections can cause longer hospital stays, greater health care costs, and increased pain, stress, and anxiety for patients (Harrington, 2014), it is imperative that all surgery centers and operating rooms implement specific plans and protocols to prevent surgical site infections.  Regular audits to track rates of infection are also important to monitor if policies and procedures are effective in preventing these types of infection.

Background Increased infection risk in inflammatory rheumatic diseases may be due to inflammation or immunosuppressive treatment. The influence of tumor necrosis factor (TNF) inhibitors on the risk of developing surgical site infections (SSIs) is not fully known. We compared the incidence of SSI after elective orthopedic surgery or hand surgery in patients with a rheumatic disease when TNF inhibitors were continued or discontinued preoperatively. Patients and methods we included 1,551 patients admitted for elective orthopedic surgery or hand surgery between January 1, 2003 and September 30, 2009.

Patient demographic data, previous and current treatment, and factors related to disease severity were collected. Surgical procedures were grouped as hand surgery, foot surgery, implant-related surgery, and other surgery. Infections were recorded and defined according to the 1992 Centers for Disease Control definitions for SSI. In 2003-2005, TNF inhibitors were discontinued perioperatively (group A) but not during 2006-2009 (group B).

Results In group A, there were 28 cases of infection in 870 procedures (3.2%) and in group B, there were 35 infections in 681 procedures (5.1%) (p = < 0.05). Only foot surgery had significantly more SSIs in group B, with very low rates in group A. In multivariable analysis with groups A and B merged, only age was predictive of SSI in a statistically significant manner. Interpretation Overall, the SSI rates were higher after abolishing the discontinuation of anti-TNF perioperatively, possibly due to unusually low rates in the comparator group. None of the medical treatments analyzed, e.g. methotrexate or TNF inhibitors, were significant risk factors for SSI. Continuation of TNF blockade perioperatively remains a routine at our center.

For ethical and legal reasons, patients must be given enough information to be fully informed before deciding to undergo a major treatment, medical procedure or risky diagnostic measure. Impact of research must be acquired from the patient and documented in writing before any significant treatment or medical procedure can begin.

 The standard practice for most hospitals had been for physicians to determine how best to provide information to their patients regarding the proposed procedure. In most cases, this information was provided by physician, orally and over time, and often in the physician’s office. Hospital consent forms were used to legally confirm that an exchange of information had taken place. They did not contain all of the information that had been exchanged or the names of all the people who would be involved in a procedure, because they were often unknown at the time of consent and might change.

 The American Medical Association (AMA) defines Impact of research as “the process of communication between a patient and physician that results in the patient’s authorization or agreement to undergo a specific medical intervention.

Impact of research is required for risky or major medical treatment, and each HDO has been left to develop its own list of surgeries, procedures or situations where Impact of research is required. Although TJC has set forth a standard that hospitals must establish and follow policies that describe which procedures or care, treatment or services require Impact of research, there may also be legal requirements based on state or country recommendations. Exceptions often include “simple and common” procedures, where the risks from such treatment are commonly understood to be remote, and life-threatening emergencies requiring immediate treatment. If the patient is incapable of giving Impact of research, the law presumes that he or she would consent to life-saving treatment.

Impact of research is about educating the patient, acquiring consent for treatment, and managing liability for the hospital and clinician. True Impact of research, however, requires more than an executed form. The consent form should acknowledge patient consent, and the Impact of research process should ensure that the information has been received and understood by the patient. Without that comprehension, there is only legal consent

 Patients should understand and agree to the potential consequences of their treatment and care. However, patients often do not read educational material, feel comfortable asking questions, or even read Impact of research forms thoroughly before or after they sign them — and often do not understand them if they do. Impact of research forms are exercises in extremes — complex and dense with medical and legal jargon, or so sparse (procedure or treatment name, short summation of why it is to be done, and a generic summary of risks, such as death, blindness, permanent paralysis) that they only make cursory mention of the risks involved in a proposed treatment or surgery. Both are introduced at a time when the patient is under stress, distracted and in pain. Patients, therefore, rely heavily on the advice and guidance of their physicians for understanding and clarity.

References:

• Ercole, F., Franco, L., Macieira, T., Wenceslau, L., Nascimento de Resende, H., & Chianca, T. (2011). Risk of surgical site infection in patients undergoing orthopedic surgery. Revista Latino-Americana De Enfermagem, 2011 Nov-Dec; 19 (6): 1362-8. https://dx.doi.org.library.gcu.edu:2048/10.1590/S0104-11692011000600012
• Ribeiro, J. C., Benedita dos Santos, C., Bellusse, G. C., Rezende, V., & Galvao, C. M. (2013). Occurrence and risk factors for surgical site infection in orthopedic surgery. Acta Paulista De Enfermagem, 26(4), 353-359. Retrieved from https://eds.a.ebscohost.com.library.gcu.edu:2048/ehost/pdfviewer/pdfviewer?sid=00ca7250-05f0-4628-98f8-b69bf3cf9c5d%40sessionmgr4003&vid=4&hid=4203
• Rajkumari, N.; Gupta, A. K.; Mathur, P.; Trikha, V.; Sharma, V.; Farooque, K.; Misra, M. C. Outcomes of surgical site infections in orthopedic trauma surgeries in a tertiary care center in India. Journal of Postgraduate Medicine, 2014 Jul-Sep; 60 (3): 254-9. https://dx.doi.org.library.gcu.edu:2048/10.4103/0022-3859.138731
• Berthold, Elisabet; Geborek, Pierre; Gülfe, Anders. Continuation of TNF blockade in patients with inflammatory rheumatic disease. An observational study on surgical site infections in 1,596 elective orthopedic and hand surgery procedures. Acta Orthopaedica, 2013 Oct; 84 (5): 495-501. https://dx.doi.org.library.gcu.edu:2048/10.3109/17453674.2013.842431
• Ercole, F., Franco, L., Macieira, T., Wenceslau, L., Nascimento de Resende, H., & Chianca, T. (2011). Risk of surgical site infection in patients undergoing orthopedic surgery. Revista Latino-Americana De Enfermagem, 2011 Nov-Dec; 19 (6): 1362-8. https://dx.doi.org.library.gcu.edu:2048/10.1590/S0104-11692011000600012
• Ribeiro, J. C., Benedita dos Santos, C., Bellusse, G. C., Rezende, V., & Galvao, C. M. (2013). Occurrence and risk factors for surgical site infection in orthopedic surgery. Acta Paulista De Enfermagem, 26(4), 353-359. Retrieved from https://eds.a.ebscohost.com.library.gcu.edu:2048/ehost/pdfviewer/pdfviewer?sid=00ca7250-05f0-4628-98f8-b69bf3cf9c5d%40sessionmgr4003&vid=4&hid=4203
• Rajkumari, N.; Gupta, A. K.; Mathur, P.; Trikha, V.; Sharma, V.; Farooque, K.; Misra, M. C. Outcomes of surgical site infections in orthopedic trauma surgeries in a tertiary care center in India. Journal of Postgraduate Medicine, 2014 Jul-Sep; 60 (3): 254-9. https://dx.doi.org.library.gcu.edu:2048/10.4103/0022-3859.138731
• Berthold, Elisabet; Geborek, Pierre; Gülfe, Anders. Continuation of TNF blockade in patients with inflammatory rheumatic disease. An observational study on surgical site infections in 1,596 elective orthopedic and hand surgery procedures. Acta Orthopaedica, 2013 Oct; 84 (5): 495-501. https://dx.doi.org.library.gcu.edu:2048/10.3109/17453674.2013.842431
• Ercole, F., Franco, L., Macieira, T., Wenceslau, L., Nascimento de Resende, H., & Chianca, T. (2011). Risk of surgical site infection in patients undergoing orthopedic surgery. Revista Latino-Americana De Enfermagem, 2011 Nov-Dec; 19 (6): 1362-8. https://dx.doi.org.library.gcu.edu:2048/10.1590/S0104-11692011000600012
• Ribeiro, J. C., Benedita dos Santos, C., Bellusse, G. C., Rezende, V., & Galvao, C. M. (2013). Occurrence and risk factors for surgical site infection in orthopedic surgery. Acta Paulista De Enfermagem, 26(4), 353-359. Retrieved from https://eds.a.ebscohost.com.library.gcu.edu:2048/ehost/pdfviewer/pdfviewer?sid=00ca7250-05f0-4628-98f8-b69bf3cf9c5d%40sessionmgr4003&vid=4&hid=4203
• Rajkumari, N.; Gupta, A. K.; Mathur, P.; Trikha, V.; Sharma, V.; Farooque, K.; Misra, M. C. Outcomes of surgical site infections in orthopedic trauma surgeries in a tertiary care center in India. Journal of Postgraduate Medicine, 2014 Jul-Sep; 60 (3): 254-9. https://dx.doi.org.library.gcu.edu:2048/10.4103/0022-3859.138731
• Berthold, Elisabet; Geborek, Pierre; Gülfe, Anders. Continuation of TNF blockade in patients with inflammatory rheumatic disease. An observational study on surgical site infections in 1,596 elective orthopedic and hand surgery procedures. Acta Orthopaedica, 2013 Oct; 84 (5): 495-501. https://dx.doi.org.library.gcu.edu:2048/10.3109/17453674.2013.842431