Ntibiotic Prophylxis in Spinl Fusion Surgery

Transcription

1 ARTÍCULO ORIGINAL Complince with ntibiotic prophylxis in spinl fusion surgery nd surgicl wound infection Gil Rodríguez-Crvc,* M. Concepción Villr del Cmpo, Rfel González-Díz,, Jvier Mrtínez-Mrtín,, Adolfo Toledno-Muñoz, Mnuel Durán-Poved * Unidd de Medicin Preventiv y Slud Públic, Deprtmento de Medicin. Universidd Complutense. Mdrid. Unidd de Cirugí de Column. Deprtmento de Cirugí Ortopédic y Trumtologí. Hospitl Universitrio Fundción Alcorcón. Mdrid. Deprtmento de Medicin y Cirugí. Universidd Rey Jun Crlos. Alcorcón. Mdrid. ABSTRACT Bckground. Surgicl wound infection is n importnt compliction of spinl surgery. Antibiotic prophylxis hs served to decrese its rtes significntly, with the ensuing reduction in hospitl sty, costs, nd morbidity nd mortlity. To dte, lrge ssessment of the degree of complince with ntibiotic prophylxis in spinl fusion surgery hs not been undertken in Spin with lrge prospective studies. We sought to ssess the degree of complince with our ntibiotic prophylxis protocol mong ptients who underwent spinl fusion surgery nd its effect on surgicl wound infection. Mteril nd methods. A prospective cohort study ws crried out. Six hundred nd forty ptients with t lest 1-yer clinicl followup who underwent spinl fusion surgery were included. Percentge of dministrtion nd degree of complince with protocol ws studied. Both overll nd the different spects of prophylxis received by ptients to those stipulted in the protocol in force t our hospitl were compred. Percentges of complince were ssessed nd the effect of prophylxis complince on the incidence of infection ws estimted using the Reltive Risk. Results. The study covered 640 ptients. Overll complince with the protocol ws 71.5% (95% CI = ). The most frequent cuse of non-complince with the protocol ws the durtion of recommended ntibiotic prophylxis (77.8%). Incidence of surgicl wound infection ws 4.1% (95% CI: ). No reltionship ws found between surgicl wound infection nd ntibiotic prophylxis non-complince (RR 0.92, 95% CI = ). Conclusions. Complince nd dministrtion of ntibiotic prophylxis were high. Surgicl wound infection rte ws similr to those found in the literture lthough there is lwys room for improvement. Adecución de l profilxis ntibiótic en l cirugí de fusión espinl e infección de herid quirúrgic RESUMEN Antecedentes. Ls infecciones de herid quirúrgic son un importnte complicción en l cirugí espinl. L profilxis ntibiótic h servido pr disminuir ls tss de infección con l consiguiente reducción en l estnci hospitlri, costes, morbilidd y mortlidd. En Espñ hy pocos estudios de evlución de l decución de l profilxis ntibiótic en cirugí de fusión espinl. Objetivo. Evlur l decución de l profilxis ntibiótic l protocolo de nuestro centro en pcientes que fueron sometidos cirugí de fusión espinl y su efecto sobre l infección en herid quirúrgic. Mteril y métodos. Se llevó cbo un estudio de cohortes prospectivo. Se incluyeron 640 pcientes que fueron sometidos cirugí de fusión espinl y fueron seguidos clínicmente durnte un ño. Se estudió el grdo de dministrción y decución de l profilxis l protocolo hospitlrio, de form globl y pr criterio de evlución: ntibiótico de elección, ví de dministrción, dosis, tiempo de inicio y durción de l prescripción ntibiótic. Se describieron ls distribuciones de frecuencis y los porcentjes de decución l protocolo y l incidenci de infección de herid quirúrgic. El efecto de l indecución de l profilxis sobre l infección de herid quirúrgic se estudió con el Riesgo Reltivo. Resultdos. El estudio incluyó 640 pcientes. L profilxis se dministró en 99.5% de los pcientes y l decución globl l protocolo fue de 71.5% (IC95%: ). L cus más frecuente de indecución l protocolo fue l durción de l profilxis (77.8%). L incidenci de infección de herid quirúrgic fue de 4.1% y no se encontró relción entre l infección y l indecución de l profilxis ntibiótic (RR = 0.92; IC95%: ). Conclusiones. L dministrción y l decución de l profilxis ntibiótic fueron lts. L incidenci de Revist i de Investigción Clínic / Vol. 66, Núm. 6 / Noviembre-Diciembre, 2014 / pp

2 infección de herid quirúrgic fue similr l encontrd en l litertur unque siempre hy mrgen de mejor. Key words. Antibiotic prophylxis. Surgery. Spinl fusion. Surgicl wound infections. Guideline dherence. Plbrs clve. Profilxis ntibiótic. Cirugí. Fusión espinl. Infección de herid quirúrgic. Adhesión l protocolo. INTRODUCTION Nosocomil infections (NI) re undesirble complictions which occur during the hospitlistion of ptients. They occur s response to the presence of infectious gents or their toxins tht were either not present or were in their incubtion period t the dte of the ptient s dmission, 1 nd re complictions rising from vrious medicl-surgicl interventions fter 48 h of hospitliztion. Surgicl wound infection (SWI) is the third leding cuse of NI 2 fter urinry trct nd respirtory infections nd its incidence is linked to specific surgicl circumstnces nd intrinsic nd extrinsic ptient-relted fctors. 3 Surgicl infection rtes in orthopedic surgery involving spinl fusion stnd t round 3.5% 4 nd trnslte s n increse in men sty, rise in helthcre costs nd decline in qulity of life. 5 Antibiotic prophylxis is one of the most widely used preventive mesures but its systemtic use in clen surgery is controversil. Its dverse effects my outweigh the benefits resulting from reduction in infection rtes. 6 Optiml prophylxis is tht which ensures dequte concentrtion of the ntibiotic of choice in blood, tissue nd surgicl site throughout the time during which the incision remins open nd for few more hours fter it is closed. 7 It is thus fundmentl for protocols to be implemented t hospitls, specifying ntibiotic prophylxis guidelines tht re designed to enhnce complince nd effectiveness. 8 Our hospitl hs in plce protocol for ntibiotic prophylxis dministrtion, drwn up nd updted in line with the ltest recommendtions in the literture, s well s spinl surgicl site infection surveillnce nd monitoring system. Accordingly, this study sought to ssess the degree of complince with our ntibiotic prophylxis protocol mong ptients who underwent spinl fusion surgery nd its effect on surgicl wound infection. MATERIAL AND METHODS A prospective cohort study ws conducted on the degree of complince with ntibiotic prophylxis in spinl fusion surgery. The ssessment took plce t the Fundción Alcorcón University Teching Hospitl nd ws performed by the preventive medicine nd orthopedic surgery nd trumtology deprtments. The ptients included in the study were those who hd undergone spinl fusion surgery. Tble 1 shows detiled list of the surgicl procedures included, long with the pertinent codes of the Interntionl Clssifiction of Diseses, Ninth Revision, Clinicl Modifiction (ICD-9-CM) grouped under the Centres for Disese Control (CDC)/Ntionl Helthcre Sfety Network FUSN procedures. Smple size ws estimted with 95% confidence level, ccurcy of 3%, expected complince of 85% nd envisged losses to follow-up of 5%. A totl 572 interventions were thus deemed necessry. We obtined the ethics nd reserch committees pprovl to crry out the study. To ensure the smple size nd include complete nnul periods, study included ptients operted from Jnury 2007 to My The study finished in My 2013 to ensure yer s follow-up both clinicl nd epidemiologicl from the dte of surgery for ll the ptients. To this end, ptients were cliniclly followed up for one yer by reference to surgicl wound progression, clinicl profile nd microbiologicl results, s per the CDC definitions. 1 Exclusion criterion ws defined s suspicion or confirmtion of infection t the dte of the intervention. The study vribles were ge, sex, comorbidity, nd the vrious spects of ntibiotic prophylxis, including ntibiotic of choice, route, dose, time of dministrtion nd durtion. We recorded pre-surgicl complince with ntibiotic prophylxis (pproprite or inpproprite) nd presence or bsence of SWI. In long surgeries second dose of ntibiotic ws dministered during the surgicl procedure. Swbs were tken when surgicl wound infection suspicion. In the event of ny SWI being registered, its depth (superficil, deep incisionl nd orgn-spce) nd custive micro-orgnism were noted. Microbiologicl studies to identify the microorgnisms implicted were performed using MicroScn Wlkwy (Siemens ). Rodríguez-Crvc G, et l. Complince ntibiotic prophylxis spinl fusion. Rev Invest Clin 2014; 66 (6):

3 Tble 1. Procedures studied nd ICD-9-CM codes.* Code Intervention 81.0 Spinl fusion Spinl fusion, not otherwise specified Atls-xis spinl fusion Dorsl nd dorsolumbr fusion of the nterior column, nterior technique Dorsl nd dorsolumbr fusion of the posterior column, posterior technique Lumbr nd lumboscrl fusion of the nterior column, nterior technique Lumbr nd lumboscrl fusion, trnsverse process technique Lumbr nd lumboscrl fusion, posterior technique *Interntionl Clssifiction of Diseses, Ninth Revision, Clinicl Modifiction. Tble 2.. Summry of ntibiotic prophylxis protocol for spinl surgery. Guideline Antibiotic Dose Route Initition Stndrd Cefonicide 1 g Intrvenous min prior to surgery Allergic to bet-lctm ntibiotics Vncomycin 1 g Intrvenous min prior to surgery A descriptive study of the smple ws conducted, with qulittive vribles being described with their frequency distribution (number nd percentges) nd compred using the χ 2 or exct-fisher s test. Quntittive vribles were described with their men nd stndrd devition (SD) or their medin nd interqurtilic rnge (IQR). The normlity criterion ws evluted using the Sphiro-Wilk test. Two-ctegory quntittive vribles were compred using the Student s-t test. Degree of complince ws studied by compring the different spects of prophylxis received by ptients to those stipulted in the protocol in force t our hospitl. Protocol complince ws ssessed, both overll nd individully, for ll spects envisged. Responsibility for dministering the protocol shown in tble 2 ws borne by the nesthetists nd ssessment of ntibiotic prophylxis complince ws nonymous by checking medicl records without informing nesthetists in order to ensure blindness. Incidence of SWI fter the follow-up period ws evluted, nd the effect of prophylxis complince on the incidence of infection ws estimted using the Reltive Risk (RR) of infection with its 95% confident intervl. To record the dt, purpose-mde dt-collection sheet nd reltionl, normlised dtbse were designed in Microsoft Access. All sttisticl nlyses were performed using the SPSS v19 sttisticl progrmme. Sttisticl significnce ws considered P < RESULTS The study covered 640 ptients. Of this totl, 284 were performed on men (44.5%) nd 356 on women (55.5%) (P = 0.005). The men ges of the ptients intervened were s follows: 57.5 yers overll (IQR = 30-63); 56.3 yers (IQR = 29-64) for men; nd 58.1 yers (IQR = 27-67) for women (P = 0.48). In ll the cses studied, dministrtion of ntibiotic prophylxis ws indicted by the chrcteristics of the intervention of spinl fusion. Prophylxis ws dministered in 635 interventions (99.2%). We could not document dministrtion of prophylxis in 5 ptients. Overll complince with the protocol, tking ll the different spects into ccount, ws 71.5%, (95%CI = ), nd ws indequte in 181 ptients (28.5%). Indequcy occured in 189 prophylxis dministrtions nd in 8 ptients there were more thn one cuse of indequcy. Tble 3 shows the degree of complince with nd dpttion to the protocol shown by the different spects of ntibiotic prophylxis. Among the cuses of non-complince with the protocol listed bove, durtion of recommended ntibiotic prophylxis wrrnts specil mention. This indequcy ws due to the fct tht more thn one dose ws dministered insted of dministering only one dose s specified in the protocol. Medin time of dministrtion before surgery ws 33 min (IQR = 28-39). Choice indequcy ccounted for 17 ptients to whom neither cefonicide nor vncomycin were dministered. They were rther dminis- 486 Rodríguez-Crvc G, et l. Complince ntibiotic prophylxis spinl fusion. Rev Invest Clin 2014; 66 (6):

4 487 Rodríguez-Crvc G, et l. Complince ntibiotic prophylxis spinl fusion. Re Cl s Rev Invest Clin 2014; 66 (6): tered cefzolin (9), ciprofloxcin (5) nd moxicillin/ clvulnic (3). A detiled brekdown of ll cuses of non-complince is depicted in figure 1. Overll incidence of infection fter the follow-up period ws 4.1% (95%CI = ), with 12 cses of superficil nd 14 cses of deep incisionl or orgnspce surgicl site infections. Sixty-nine percent of infections were dignosed during hospitlistion nd 31% fter dischrge. There were 24 positive microbiologicl smples in the ptients with surgicl wound infection nd the most frequent microorgnisms were negtive cogulse Stphylococcus (21%) nd Stphylococcus ureus (21%). Two of the ptients were dignosed of surgicl wound infection only by clinicl chrcteristics then there were no positive microbiologicl smples. The microorgnisms implicted in these infections re shown in figure 2. No reltionship ws found between SWI nd ntibiotic prophylxis non-complince (RR = 0.92, 95%CI: ). Regrding comorbidity, the most importnt risk fctors found were prevlence of dibetes mellitus of 13%, obesity 12%, COPD 6%, cncer 6% nd renl insufficiency 3%. Ptients with dibetes mellitus (RR = 2.88; CI95%: ) nd COPD (RR = 4.66; CI95%: ) hd higher surgicl wound infection risk. DISCUSSION Surgicl wound infection is n importnt compliction of spinl surgery. Antibiotic prophylxis hs served to decrese SWI rtes significntly, with the ensuing reduction in hospitl sty, costs, nd morbidity nd mortlity. There re studies which show tht ntibiotic prophylxis is cpble of preventing more thn 50% of infections. 9,10 Two recent met-nlyses showed tht ntibiotic prophylxis ws beneficil in spinl surgery, even in cses where expected infection rtes without ntibiotic tretment were low, 11 nd tht it ws effective in terms of reducing risk of infection in ll types of surgery. 12 Our study focused on ssessing the dministrtion of ntibiotic prophylxis in ptients who underwent bck surgery involving spinl fusion. As lmost ll the ptients who were intervened received prophylxis, this entiled degree of complince of close to 100%. Such high degree of complince ws not ttined in the bibliogrphy consulted. 13 It is importnt to note tht the ssessment ws mde without the knowledge of the nesthetists, thus preventing their ttitude from influencing the high degree of complince of dministrtion of ntibiotic prophylxis nd controlling the Hwthorne effect. When ll the fctors were evluted jointly, overll percentge complince of prophylxis proved to be 71.5%. This percentge is somewht lower thn the degrees of overll complince reported in the literture, though these refer to multiple surgicl procedures nd not specificlly to spinl surgery. 14,15 If one ddresses ech of the protocol criteri individully (time of initition of prophylxis, durtion of prophylxis, route of dministrtion, dose nd. Tble 3. Degree of complince of ntibiotic prophylxis (n = 635). Complince (n) Complince (%) 95%CI Time of initition Longer durtion Dosge Route of dmin Choice of ntibiotic Overll Figure 1. Cuses of non-complince with the ntibiotic prophylxis protocol (n = 189) Durtion Beginning Choice Route Dose

5 Stphylococcus epidermidis Stphylococcus coguls negtive Stphylococcus ureus 8 6 Enterobcter cloce Escherichi coli Microorgnisms Grm - Microorgnisms Grm + Klebsiell pneumonie Proteus mirbilis Serrti mrcescens F Figure 2.. Aetiology of surgicl site infections. choice of ntibiotic), it will be seen tht, sve for durtion of prophylxis, the degree of complince exceeded 90% for ech of these spects. These percentges re in rnge equl to or higher thn those found in the literture. 14,16 With respect to the durtion of ntibiotic prophylxis, the single spect to disply the lowest degree of complince with the protocol, it ws inpproprite becuse the ntibiotic hd been dministered for longer thn the recommended time. This is very importnt, much discussed spect 17 in the field of ntibiotic prophylxis. Tody it is known tht the ntibiotic dose used should be one whereby vlues bove the minimum inhibitory concentrtion re obtined for time which is pprecibly longer thn tht of the surgicl procedure. The dose should be repeted if the intervention lsts longer thn twice the hlf-life of the ntibiotic or there is loss of blood of more thn 1.5 L fter dministrtion of fluids. 18 There is one study which shows the time during which prophylxis is dministered s n independent risk fctor for the ppernce of SWI. 19 At ll events, rther thn seeking to ssess the technicl spects of the protocol or the risk fctors implicted in the infection s do other studies, our study sought to ssess protocol complince in order to identify points for improvement. However, s durtion ws longer thn tht indicted in the protocol, its effect could hve been not to increse the incidence rte of infection but rther to diminish it, lthough it cn result in higher costs of hospitlistion nd microbiologicl resistnce. 23 In our cse series dibetes mellitus nd COPD were risk fctors of surgicl wound infection s communicted by other uthors. 24,25 Incidence of infection in our cse series ws somewht higher thn tht published by the CDC 1 nd other studies 26 for this procedure nd similr to those in our field of influence. 27 When it comes to estimting incidence of surgicl infection, follow-up time constitutes n essentil point of this study, since our cses were evluted within one yer fter surgery then implnts were left in plce fter the procedures. This should hve result in n pproprite estimted incidence with no bis. 28 As result of our ssessment some mesures were tken, such s communicte the results to the physicins in chrge nd ll the helthcre tem nd we focused on the in plce protocol to remind it nd to try to improve the dherence to its recommendtions. The result of this intervention will be ssessed t n erly future. CONCLUSION Stress should be lid on the importnce of the implementtion nd ongoing ssessment of ntibiotic prophylxis protocols in surgery, so s to be ble to tke timely mesures trgeted t reducing incidence of SWI s much s possible. In our study both complince nd dpttion of ntibiotic prophylxis were high but there is lwys room for improvement nd, in this regrd, the ctive prticiption of ll professionls involved is vitl. ACKNOWLEGDMENTS We thnk Fundción Mutu Mdrileñ for its support to crry out this study. 488 Rodríguez-Crvc G, et l. Complince ntibiotic prophylxis spinl fusion. Rev Invest Clin 2014; 66 (6):

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