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~~bEfficacy of Irrigation in Elective, Instrumented Spinal Fusions



Ben Rentfrow, DO, MPT,
Mt Clemens Regional Medical Center, Mt Clemens, MI

Kanwaldeep Sidhu, MD
St Clair Orthopedics, St Clair Shores, MI








The authors do not have any financial disclosures to report that may have influenced the submitted work. A $250 prize was awarded to the 1st author at the 2011 Michigan State University Orthopedic Research Competition for the paper.

Please send correspondence to Ben Rentfrow, DO, Detroit Receiving Hospital, 4201 St Antoine BLVD, Detroit, MI  48201. 313-966-7786. Fax 313-966-8400. E-mail  HYPERLINK "mailto:Dover1242@sbcglobal.net" Dover1242@sbcglobal.net



Abstract


Study Design: Retrospective case-control
Objective: Demonstrate the absence of irrigation for elective instrumented spine surgery does not change infection rates.
Summary of Background Data: Causes of postoperative spinal surgery infections (POSSI) are
multifactorial and related to both patient and procedural influences. Because of these complexities, predictable infection rates likely exist that do not extrapolate to 0%. There has been no study that has proven that lack of irrigation, antibiotic laden or otherwise, increases the risk of postoperative infection in elective spine surgery.
Methods: From 2005 to 2010, 103 patients were indentified who underwent elective spine surgery with instrumentation. The medical records of patients who developed infection were examined. Data on both superficial and deep infections were recorded.
Results: Of the 103 patients, 7 (6.8%) developed superficial infection and there were no deep infections. Seven superficial infections out of 103 cases (6.8%) are about in the middle of the 0-15% range reported in the literature. There was no statistically significant difference between the lower range of infection (p=0.11) or the higher range (p=0.07).
Conclusion: Intraoperative irrigation, in elective spine surgery, contributes to the cost of health care, and irrigating may even be detrimental to the patient as it further lengthens OR time. Intraoperative irrigation, with or without additives, in the prevention of POSSI, may be an unnecessary step in elective spinal surgery.
Key Words: Irrigation, Fusion, Elective, Spinal, Surgery
Introduction

Post operative spine surgery infection (POSSI) is an infrequent yet serious complication for patients who undergo spine surgery. Along with patient selection, perioperative measures are taken prophylactically to prevent infection from overcoming the host�s defenses. POSSI leads to repeated surgical procedures, the need for suppressive antibiotics, hardware removal, pseudoarthrosis, progression of deformity, and prolonged hospitalization.1 The overall cost of care may increase more than 4-fold with surgical site infection, and the overall mortality risk is doubled.2, 3 There are few reports of the impact of surgical technique on surgical site infection as most technical factors are difficult to evaluate. Recently, studies have discussed the value of irrigation for prevention of POSSI.
Topical irrigation in spine surgery remains a controversial issue in the prevention of wound infection. In 1979, the first known report of intraoperative irrigation was by Malis who published 1732 cases using 1 gram of intravenous vancomycin, gentamycin 80 milligrams intramuscularly, and streptomycin 50 milligrams in each liter of irrigating saline � which he reported led to a virtual elimination of postoperative sepsis over a 20-year period.4 Subsequently, many authors have reported similar studies touting low infection rates with various additives in irrigation.2,3,5,6
Masters Techniques in Orthopedic Surgery: Spine textbook cited irrigation with normal saline, polymyxin, bacitracin, saline and neomycin, and aspecific �antibiotic saline.�1 Some chapters exclude irrigation altogether suggesting there is no standard by which spine irrigation is performed. Furthermore, the absence of irrigation has never been shown to have a higher postoperative rate of surgical site wound infection. The belief that wound irrigations are beneficial to spine surgery has never been challenged in our review of the literature. The goal of this study is to show that the absence of irrigation for instrumented spine surgery does not change rates of infection.

Materials and Methods

A chart review was carried out on 103 consecutive, elective, instrumented cases that occurred between 2006 and 2010 at Mt Clemens Regional Medical Center, Mt Clemens, MI (a level II Trauma hospital). Patients who had undergone an elective spinal operation were identified by querying the hospital medical database for admissions coded with International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) procedure codes for spinal arthrodesis (8108 and 8162). Patient charts and electronic medical records were used to collect the data. The Centers for Disease Control and Prevention definition of surgical site infection was used: wound infections occurring within one year of hardware implantation were considered surgical site infections.7   Inclusion criteria included either a cervical or lumbar elective procedure where hardware was placed. Only cases that were same day elective surgery admissions were included to eliminate trauma, tumor, infection, or a pre-surgical hospital admission that might skew the sample. For a case to meet inclusion criteria of a deep
intraoperative infection, there had to have an operative incision, have hardware of any type placed, and positive intraoperative culture positive for bacterial infection taken within one year postoperatively.
Since no deep infections were identified, suspected superficial infections were recorded after patient was put on oral antibiotics when erythema or wound drainage was identified during a postoperative visit. An examination of the operative note was completed to make sure that no irrigation had occurred during the initial procedure (as was the senior author�s usual technique) as well as documentation that instrumentation had occurred. The study protocol was approved by the Mt Clemens Medical Center Institutional Review Board.
All operations were performed by the same senior surgeon (KSS) using the same techniques (standard posterior midline approach for lumbar cases and left sided anterior approach for cervical cases). Weight dosed cefazolin or clindamycin (if penicillin allergic) was given within one hour preoperatively and two additional doses postoperatively. Standard operating theatre included betadine or chlorohexadine prep and use of povidone-iodine, sterile adhesive film over the surgical site. No ultraviolet lights or exhaust suits were used. After the placement of hardware and any needed decompression, wound closure occurred in a layered fashion and suction drains were placed. Drains were removed in lumbar cases when drainage was less than 50 ml/8hours, 30ml/8hours for cervical cases. Surgical dressings were changed when the drain was removed and changed as needed thereafter. Patients typically made their first postoperative visit 14 days from the day of surgery.

Results

Of the 103 cases reviewed, there were 54 females and 49 males. The mean age at the time of surgery was 50. There were 28 cervical spine cases and 75 lumbar spine cases. Seven superficial infections (6.8%) were documented. There were no superficial cervical infections. Seven of 75 (9.3%) lumbar cases were superficial infections. The average age of those that had superficial infection was 62 years. There were four women and three men. Wound discharge, dehiscence, and erythema at the incision site were the most common presenting features for superficial infection. A 1st generation cephalosporin or quinilone (if penicillin allergy) were most commonly used and were continued until symptoms were absent and wounds were closed (all 2-3 months postoperatively). Three of seven patients were diabetic; all seven were being treated for hypertension. One patient used tobacco, two admitted to social alcohol use.
The incidence of deep surgical site infection at 1 year after spine surgery was 0% (0 of 103). Incidentally, one deep infection was identified at 24 months postoperatively, occurring at the level above an instrumented fusion.
Nonparametric descriptive data are presented as counts and percentages, and parametric data are presented as means with their corresponding range. Nonparametric variables were compared by calculating the chi-square test of independence. Throughout this study, a p-value d" 0.05 (two-tailed) was considered statistically significant. Minitab Statistical Software (State College, PA) was used for performing the analyses.
Seven superficial infections out of 103 cases (6.8%) are about in the middle of the 0-15% range reported in the literature. When 6.8% is compared to Olsen�s study of 2316 patients where there 2% of all types (superficial, deep incisional, and organ space),8  there is statistically no significant difference (p=0.11). Likewise, when 6.8% is compared to the high end of the reported range of 15%, there is no significant difference (p=0.07).
There were no deep infections in our series, and statistical analysis did not contribute additional information. 

Discussion

Rates of postoperative surgical site infection have ranged from 0-15%, depending on the reason for the operation, the site, the approach, and the use of instrumentation.3 Causes of postoperative spinal site infections are multifactorial and related to both patient and procedural influences. Because of these complexities, predictable infection rates likely exist that do not extrapolate to 0%. Surgical infections, in general, are a public focus because infection rates are used to compare hospitals, and insurance companies have initiated policies to not reimburse expenses related to hospital acquired infections. A 0% infection rate is not a realistic expectation and reflects a common overreliance on prophylactic antibiotics for preventing surgical infection.9
The literature has provided many risk factors for POSSI. Contributory patient related factors that are difficult to modify include age, ASA score, obesity, diabetes, smoking, previous surgery, previous infection, previous radiation, skin disorders, immunologic impairment, nutritional status, and adherence to post-op wound care instructions.9 Case factors include posterior approach, instrumentation, bone graft harvest, blood loss or blood transfusion, and case length. The most commonly infected procedure is the combined anterior/posterior fusion.10   Other factors include draping, prepping, room traffic, use of fluoroscopy. Cheng reported that instrumentation for traumatic spinal fractures carried a higher risk of infection.2   Subsequently, we elected to stratify our sample with instrumented cases to challenge the premise that irrigating these cases would still have no effect.
The goal of preventing POSSI should be to optimize our perioperative approach to maintain infection rates at an acceptably low level. Many operative and perioperative adjunct techniques have been proposed to reduce infection rates. While many show promise, few have been proven to reduce infection rates, and extrapolation of data from other surgical subspecialties (like laminar flow from total joints) may not be valid.9
Although wound irrigation is common practice, there is a lack of literature and guidelines to advise the ideal method of administration.11 In theory, the use of a local agent to irrigate a wound would be superior to systemic therapy because localized concentration could be significantly higher than levels achievable with systemic treatment, leading to improved bactericidal and bacteriostatic activity.12  Tap water and normal saline used alone may be suitable for wound irrigation; however, it is thought that the addition of additives, to normal saline in particular, may improve wound healing and prevent infection.11 The optimal additives to prevent or reduce infection rates remain controversial.  Nevertheless, additives such as antibiotics, antiseptics, and/or soaps are commonly utilized.13 
The Drug Information Group at the University of Illinois at Chicago (DIG@UIC) concluded their survey of wound irrigation additives by saying that more recent studies suggest that the addition of an antiseptic, such as providone-iodine, or a surfactant, such as castile soap, may be more beneficial in preventing wound infections compared to normal saline or antibiotic irrigations. The data surrounding antibiotic irrigations specifically are conflicting and efficacy has yet to be established. Therefore, the DIG@UIC concluded, antibiotic irrigations for the prevention of wound infections should not be routinely used. 11
The association between intraoperative antibiotic irrigation and POSSI has been investigated over the last four decades, and no consensus has been achieved. Adherence to strict techniques may reduce the incidence of postoperative infections, but most technical factors are objectively difficult to evaluate. There are many authors who have cited that their particular recipe for postoperative infection has eliminated the problem, but any study that denotes a 0% infection rate ignores the fact that infection is likely multifactorial � influenced by both procedure and the patient.3 These studies should be interpreted with caution. At the time of this paper, there has been no study that has proven that lack of irrigation, antibiotic laden or otherwise, increases the risk of postoperative infection.
Given the added operating room time in delivering irrigation, along with the time needed to prepare irrigation formulas (usually 24 hours before, since antibiotic powders are slow to dissolve) � costs for delivering irrigation may be better shifted to other areas of the healthcare. At our institution, the charge for antibiotic (neomycin, polymixin, bacitracin) irrigation is $351/3L and $90/3L for Lactated Ringers irrigant. Operating room time at our institution is charged at an average of $5386/hour. A generous estimate of three minutes is needed to irrigate every case at an approximated charge of $289/3 minutes of OR time plus $351 for antibiotic irrigation. In 2004, the AAOS estimated there were 285,000 cervical and lumbar spine fusions (150,000 lumbar and 135,000 cervical).14   At 2004 cases volumes, 285,000 fusions would cost an additional $182,400,000 in fees nationally. This may represent an unnecessary demand on already overwhelmed health care resources. Furthermore, the time spent on techniques that do not directly improve outcomes may actually have the opposite effect as anything that increases OR times increases risk of postoperative infection.13
Admittedly, many cases benefit from irrigation. Specifically traumatic, infected, and patients with comorbidities that are associated with infection may justify the need for intraoperative irrigation. Limitations of this review include sample from one hospital in suburban Detroit and may not reflect the population at large. In addition, other reasons like operative techniques may account for low infection rates in our study. Without controls, we cannot conclude which aspects of our protocol, taken out of our particular setting and applied to other hospitals with existing infection rates, would definitely result in a decline of sepsis after spinal surgery.4   Patient selection purposely excluded patients with prior histories of previous instrumentation, prior infection, and active trauma which may benefit from the effects of irrigation in order target a population and minimize confounding. More studies with larger samples are needed for both those that prefer to irrigate, and those that prefer to forgo irrigation.
The goal of this paper was to point out that intraoperative irrigation, with or without additives, in the prevention of POSSI, may be an unnecessary step in elective spinal surgery. Intraoperative irrigation, as previously shown, contributes to the cost of health care, and it can be argued that irrigating may even be detrimental to the patient as it further lengthens OR time. We conclude that, based on the data, the best rates reported in the medical literature are statistically no better than ours. This is a favorable outcome. A survey of surgeon practices and infection rates may yield an answer to whether or not intraoperative irrigation is necessary in any spine case. Ironically, those surgeons that do not routinely irrigate may be reluctant to share results, for fear of being seen as offering �less� to their patients.
References
1. Bradford DS, Zdeblick TA. Masters Techniques in Orthopedic Surgery: Spine. Lippincott,
Williams, & Wilkins; 2004.
2. Cheng MT, Chang MC, Wang ST, et al. Efficacy of Dilute Betadine Solution Irrigation in the
Prevention of Postoperative Infection in Spinal Surgery.   Spine.  2005; 30:15: 1689-1693.
3. Watanabe M, Sakai D, Matsuyama D, et al. Risk factors for Surgical Site Infection following
Spine Surgery: Efficacy of Intraoperative Saline Irrigation. Journal of Neurosurgery: Spine. 
2010; 12: 540-546.
4. Savitz SI, Savitz MH, Golstein HB, et al. Topical Irrigation with Polymyxin and Bacitracin for
Spinal Surgery.    Surgical Neurology.  1998; 50: 208-212
5. Chang FY, Chang MC, Wang ST, et al. Can Provo-iodine solution be safely used in a Spinal
Surgery?    European Spine Journal.  2006; 15: 1005-1014
6. Rosenstein BD, Wilson FC, Funderburk CH. The Use of Bacitracin Irrigation to Prevent
Infection in Postoperative Skeletal Wounds.  An Experimental Study.    J Bone Joint Surg. 
1989; 71: 427-430.
7. Horan TC, Gaynes RP, Martone WJ, et al. CDC definitions of Nosocomial Surgical Site
Infections, 1992: A Modification of CDC definitions of Surgical Wound Infections. Infect
Control Hosp Epidemiol.  1992; 13: 606�608.
8. Olsen MA, Nepple JJ, Riew D, et al. Risk Factors for Surgical Site Infection following
Orthopedic Spinal Operations.   J Bone Joint Surg.  2008; 90: 62-69.
9. Schuster JM, Rechtine G, Norvell DC, et al. The Influence of Perioperative Risk Factors and
Therapeutic Interventions on Infection rates after Spine Surgery.   Spine.  2010; 35:9: S125-
S137.
10. Fang A, Hu SS, Endres N, Bradford DS. Risk factors for Infection after Spinal Surgery.  Spine.
2005; 30:12: 1460.
11. The University of Illinois at Chicago College of Pharmacy. The Drug Information Group. What is
the clinical data surrounding irrigation methods for the prevention of wound infections? Available
at: http://dig.pharm.uic.edu/faq/wound_infections.aspx. Last accessed 7/8/2010.
12. Matthaiou D, Peppas G, Falagas ME. Meta-analysis on surgical infections. Infect Dis Clin
North Am. 2009; 23(2): 405-430.
13. Crowley DJ, Kanakaris NK, Giannoudis PV. Irrigation of the wounds in open fractures. J Bone
Joint Surg. 2007; 89-B(5): 580-585.
14. The Burden of Musculoskeletal Disease in the United States. American Academy of O78@C�����_	a	�	�	�	
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Acknowledgements: The authors would like Dr Robert Jarski, PhD, for his statistical consultation and Laurie Jackowski for her assistance in data collection.

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