Uitgangsvraag

Wat is het beleid met betrekking tot het gebruik van een combinatie van mupirocine en chloorhexidine in patiënten die een totale heupprothese ontvangen?

Aanbeveling

Op basis van de literatuur heeft de werkgroep onvoldoende argumenten om enigerlei aanbeveling te doen omtrent preoperatieve screening op S. aureus en dekolonisatie met mupirocine en chloorhexidine bij patiënten die een totale heuparthroplastiek ondergaan.

Inleiding

Staphylococcus aureus is an important cause of post-surgical wound infections and the use of intranasal mupirocin in carriers may decrease the rate of S. aureus infections in surgical patients.

 

Guidelines such as the “Clinical practice guidelines for antimicrobial prophylaxis in surgery” by the IDSA recommend application of mupirocin intranasally for all patients known to be colonised with S. aureus and undergoing joint arthroplasty Bratzler et al., (2013). Also, the SWAB guideline on surgical prophylaxis recommends screening patients undergoing orthopaedic implantation surgery and in the case of a positive result for S. aureus, to apply both mupirocin and chlorhexidine pre-operatively, but with an exception for centres with very low infection rates.

 

Nowadays in Dutch hospitals, there are different approaches, some hospitals do not have a mupirocin protocol in orthopaedic implantation surgery, there are hospitals that only apply mupirocin to S. aureus carriers and in other hospitals all patients receive mupirocin before implantation. This lack of uniformity is undesirable, as it could result in suboptimal prevention measures, or lead to unnecessary use of mupirocin, which may cause induction of resistance and unnecessary costs.

 

A literature study was performed to assess the influence on infection rates of prophylactic mupirocin and chlorhexidine body wash, applied to all patients undergoing joint arthroplasty, to S. aureus carriers only, or to no patients at all.

Conclusies

Category 1

Very low

GRADE

Screening for S. aureus carriership and subsequent application of mupirocin and chlorhexidine pre-operatively, combined with adapted systemic prophylaxis if MRSA was detected, compared to a historical control group, seems to be associated with a lower amount of SSI.

 

Sources (Baratz, 2015; Rao, 2010; Sporer, 2016; Schweizer, 2015)

 

Category 2

Very low

GRADE

Application of mupirocin and chlorhexidine to all patients, compared to screening and application on indication, seems to be associated with a lower amount of SSI in patients who undergo total hip arthroplasty.

 

Sources Stambough, (2016)

 

Category 3

Very low

GRADE

Screening and pre-operative decolonisation of S. aureus with mupirocin and chlorhexidine on indication, compared to no application of mupirocin seems to be associated with a lower amount of revision due to infections in patients who underwent total joint arthroplasty.

 

Sources Malcolm, (2016)

Samenvatting literatuur

Description of studies

Five studies were included, which compared the differences in SSIs between a group of patients who were screened and treated according to a decolonisation protocol, compared to a control group (Baratz, 2015; Rao, 2011; Schweizer, 2015; Sporer, 2016; Stambough, 2016). One study was included, which investigated whether there is a difference in amount of revisions between a group of patients who were screened and treated according to a decolonisation protocol, compared to a control group Malcolm, (2016).

 

Because of heterogeneity in screening and decolonisation protocols used, the studies, their results and conclusions are described in three categories:

 

  • Category 1 included studies that investigated the number of SSIs after screening and application of mupirocin and chlorhexidine on indication compared to a (historical) control group with unknown history regarding application of mupirocin and/or chlorhexidine.
  • Category 2 included studies that investigated the number of SSIs after screening and application of mupirocin and chlorhexidine body wash on indication, compared to application of mupirocin and chlorhexidine body wash to all patients undergoing total joint arthroplasty.
  • Category 3 included studies that investigated the number of revisions due to SSIs after screening and application of mupirocin and chlorhexidine on indication, compared to application of chlorhexidine only.

 

Characteristics of included studies:

Category 1

In four studies regarding patients undergoing total joint arthroplasty the differences in number of SSIs after screening and application of mupirocin and chlorhexidine on indication were compared to a (historical) control group with unknown history regarding mupirocin and/or chlorhexidine (Baratz, 2015; Rao, 2011; Schweizer, 2015; Sporer, 2016). Some studies included patients in the intervention group who were not screened before surgery. These patients were all treated with mupirocin and chlorhexidine until screening results were known.

 

The retrospective clinical study by Baratz (2015) compared the infection risks of a group of patients who were screened and treated according to a decolonisation protocol (intervention group) to a historical control cohort (control group) after elective total joint arthroplasty Baratz, (2015).

 

In the intervention group, all patients were screened for nasal carriage of MSSA or MRSA pre-operatively. Carriers were treated with mupirocin intranasally (Bactroban; GlaxoSmithKline, Middlesex, UK) and chlorhexidine soap for five days, including the day of surgery. A first-generation cephalosporin (cefazolin) was given as systemic prophylaxis and patients with a β-lactam allergy received vancomycin. In addition to cefazolin, carriers of MRSA received vancomycin.

 

A patient group from a 2-year period (January 2009 to December 2010) before the implementation of the screening and decolonisation protocol was included as a control Baratz, (2015).

 

The intervention group consisted of patients who underwent primary (n = 2903) or aseptic revision (n = 531) total hip or knee arthroplasty (THA or TKA). In the intervention group, 158 patients (5%) tested positive for MRSA and 508 patients (15%) were positive for MSSA. The control group consisted of 3080 patients (primary cases, n = 2515; revision cases, n = 567). SSIs were defined according to the National Healthcare Safety Network guidelines of the Center for Disease Control and Prevention. No baseline values were given Baratz, (2015).

 

The prospective cohort study by Rao (2011) investigated the number of SSIs in patients who underwent elective total joint arthroplasty. The intervention group (n = 1440) was compared with two control groups. One concurrent control group with surgical patients who did not participate in the screening and decolonisation protocol (n = 2284) and a pre-intervention control group (n = 741) in which patients were included who underwent TJA one year before the implementation of a decolonisation protocol. No details were given regarding inclusion criteria for the pre-intervention control group, concurrent control and intervention group. Also no information is available regarding systemic prophylaxis or the use of chlorhexidine in the control groups Rao, (2011).

 

Patients in the intervention group were screened two to four weeks before surgery. Carriers of S. aureus used mupirocin nasal ointment two times per day for five days and had chlorhexidine baths daily for five days. This protocol started five days before surgery. All patients received peri-operative antibiotic prophylaxis with cefazolin, or in case of MRSA carriers or a history of MRSA or type I allergy to penicillin, vancomycin was given. In the intervention group, 321 participants were carriers of S. aureus (MSSA = 278; MRSA = 43). The reported outcome measure was SSI, with a follow-up of two years after total joint arthroplasty. No baseline values were given Rao, (2011).

 

The quasi-experimental pragmatic study by Schweizer (2015) compared the risk of SSIs in patients undergoing primary hip or knee arthroplasty (and cardiac operations) between a group of patients who were screened and treated according to a decolonisation protocol (intervention group) and a historical control group. In total 31,701 operations, performed in 20 hospitals (8 hospitals implemented the bundle for joint arthroplasties, 4 for cardiac operations, and 8 for both categories), were included (n pre-intervention = 20,642; n intervention = 11,059). Hospitals that implemented parts of the intervention during the pre-intervention period were allowed to participate Schweizer, (2015).

 

Patients in the intervention group were screened for S. aureus 10 to 14 days before surgery (no more than 30 days). Carriers of MRSA or MSSA received mupirocin intranasally twice daily for five days and bathed with chlorhexidine once daily for five days immediately before surgery. Patients with negative screening for MRSA or MSSA bathed with chlorhexidine the night and morning before operation. Patients received cefazolin or cefuroxime as peri-operative prophylaxis and in case of MRSA carriership, vancomycin was added. In case of β-lactam allergy, a combination of vancomycin and gentamicin or aztreonam was given. Patients with history of MRSA, but negative screening were treated as carriers. Patients who were not screened or whose screening results were not known received vancomycin and cefazolin or cefuroxime and decolonisation was started immediately before their operation. Mupirocin was discontinued if test results were negative. There were some differences in baseline values. The intervention group was younger, had lower CCI scores, and were less likely to have a history of MRSA carriership compared to the control group. The primary outcome measure was the amount of complex MSSA or MRSA SSIs Schweizer, (2015).

 

The observational study by Sporer (2016) investigated the effect of a screening and decolonisation protocol on the risk of SSIs in participants who underwent total hip or knee arthroplasty. The treatment protocol came into effect on January 1, 2009. Patients who underwent total joint arthroplasty between 2008 and 2009 were included in the control group (n=1440). The intervention group consisted of 9825 participants. In the intervention group, 98.6% of the patients underwent screening, 2.9% had a positive screening for MRSA and 25.1% for MSSA Sporer, (2016).

 

All patients in the intervention group were screened at least 14 days before surgery. Carriers of MSSA or MRSA were treated with 2% mupirocin ointment (Bactroban; GlaxoSmithKline, Middlesex, United Kingdom) and 2% chlorhexidine gluconate showers for five days before admission to the hospital. Cefazolin was given as antibiotic prophylaxis. MRSA patients received vancomycin, all other S. aureus–positive patients received cefazolin. Patients identified with MSSA or MRSA less than five days before admission were instructed to take showers with chlorhexidine until admission and also mupirocin until completion of 10 doses. Patients with unknown colonisation status were screened on day of admission and received mupirocin immediately before surgery and until the screening results were negative for MSSA or MRSA, or the patient had completed 10 doses. All patients, regardless of nasal colonisation, were instructed to shower the night before the operation and apply chlorhexidine, this was repeated on the morning of surgery. Peri-operative infection rates were compared from 1 year before implementation to 5 years after implementation of the screening protocol. The study mentioned that surgical skin preparation, administration of prophylactic antibiotics and environmental conditions in the operating room were not different between the control and intervention group. SSIs were monitored by the hospital within 30 days after index surgery. The criteria of the Centers for Disease Control and Prevention were used to identify SSI Sporer, (2016).

 

Category 2

In one study, the differences in number of SSIs in patients undergoing THA were compared between the application of mupirocin and chlorhexidine to all, or after entering a screening programme and application on indication Stambough, (2016).

 

The study by Stambough (2016) investigated the amount of SSIs of a decolonisation protocol in which mupirocin and chlorhexidine were applied to all, compared to the application to S. aureus carriers only. All patients who underwent elective primary hip or knee arthroplasty between March 1, 2011 and March 31, 2013 (n = 1,864) were included in the control group and in case of surgery between July 1, 2013 and July 31, 2015 (n = 2,049) in the intervention group. Patients in the control group were screened and mupirocin and chlorhexidine were given to S. aureus carriers only. In the intervention group, mupirocin and chlorhexidine were applied to all patients. Mupirocin was given for five days, including day of surgery. The use of chlorhexidine varied between the two groups: patients in the control group used day of surgery wipes, and patients in the intervention group used twice daily chlorhexidine baths for five days. Patients were followed for 90 days to detect deep SSI and PJI, which were classified according to the National Healthcare Safety Network guidelines. In most patients, IV cefazolin was given as antibiotic prophylaxis and in case of allergy to penicillin, IV vancomycin and IV aztreonam were given. Patients who resided in a nursing facility, were on dialysis, had been hospitalised within the past year, or had a documented history of MRSA infection, were administered IV vancomycin in addition to cefazolin Stambough, (2016).

 

Category 3

In one study, the differences in number of revisions due to SSIs in patients who had undergone a total joint arthroplasty was compared between a group that had been screened and had received mupirocin and chlorhexidine on indication, to a group in which chlorhexidine was applied only Malcolm, (2016).

 

The retrospective clinical cohort study by Malcolm (2016) compared the risk of revision after total joint arthroplasty between a group of patients who had been screened and treated according to a decolonisation protocol (intervention group) and a group of patients who had not been screened and had received chlorhexidine (control group). No reason was given as to why these patients had not been screened. The reported outcome measure was revision arthroplasty after THA or total knee arthroplasty (TKA). Revision was only assessed in patients with at least one year of follow-up. The criteria for revision surgery were not given Malcolm, (2016).

In the intervention group, carriers of S. aureus had received topical mupirocin for three days twice daily. All patients (both intervention and control groups) had used chlorhexidine body wipes pre-operatively and had received intravenous cefazolin as peri-operative antibiotic prophylaxis, or in case of MRSA carriage vancomycin. In total, 5678 patients were included in the study, of which 4042 (screened = 2291; not-screened = 1751) had at least one year of follow-up and were included in the analysis to report the number of revisions. The patients who had been screened (n = 2291; THA = 939; TKA = 1352), were compared to ones who had not been screened (n = 1751; THA = 700; TKA = 1051). The 1636 patients excluded from the analysis, were included in the study less than one year before the end of the study. Of the screened patients, twenty percent were colonised with MSSA and five percent were colonised with MRSA. At baseline, the intervention and control group were only different in Charlson Comorbidity index (CCI) score (p-value <0.01) Malcolm, (2016).

 

Results

Surgical site infections (SSIs)

Category 1 (number of SSIs after screening and application of mupirocin and chlorhexidine on indication compared to a (historical) control group with unknown history regarding mupirocin and/or chlorhexidine)

 

In the study by Baratz (2015), no statistically significant difference was found in SSIs between the group of patients who received mupirocin and chlorhexidine on indication (intervention group) and the historical control cohort (Relative Risk: 0.74, CI: 0.44 to 1.22, p-value = 0.28). This remains with stratification of patients based on primary (Relative Risk: 0.77, CI: 0.40 to 1.49, p-value = 0.51) and revision cases (Relative Risk:0.76, CI: 0.34 to 1.7, p-value = 0.65). All SSIs required surgical intervention. There were no statistically significant differences between the intervention and historical control group in the organisms causing the infections: MSSA (Relative Risk: 0.75, 0.23 to 2.45, p-value = 0.66), MRSA (RR: 0.48, CI: 0.20 to 1.13, p-value = 0.10) and total S. aureus (Relative Risk :0.56, CI: 0.28 to 1.11, p-value = 0.11). All identified infections required surgical intervention (intervention group, n = 27; control group, n = 33) Baratz, (2015).

 

In the study by Rao (2010) the infection rate in all patients, decreased from 2.7% in the pre-intervention control group to 1.2% in the group of patients who received mupirocin and chlorhexidine on indication (intervention group) (P = 0.009; OR 2.32 (95% CI 1.21 to 4.46). Eleven superficial (MRSA = 3; MSSA = 3; others = 5) and nine deep infections (MRSA = 5; others = 4) were found in the pre-intervention control group. Nine superficial (MSSA = 3; others = 6) and eight deep infections (MRSA = 2; others = 6) were found in the intervention group Rao, (2010).

 

In the study by Schweizer (2015) the rate of complex SSIs was lower in the group of patients who received mupirocin and chlorhexidine on indication (intervention group) compared to the historical control group (Rate Ratio = 0.48; 95% CI 0.29 to 0.80; p-value = 0.005). After stratification for type of surgery the mean rate was significantly lower in the intervention group compared to the historical control group in patients who underwent elective surgery (Rate Ratio = 0.51; 95%CI: 0.30 to 0.85; p-value = 0.009), but not in patients who underwent urgent surgery (Rate Ratio: 0.44; 95%CI: 0.07 to 2.72; p-value = 0.38) Schweizer, (2015).

 

In the study by Sporer (2016), the SSI rates were lower in the group of patients who received mupirocin and chlorhexidine on indication (intervention group) compared (2009: 0.20%; 2010: 0.59%; 2011: 0.32%; 2012: 0.53%; 2013: 0.23%; 2014: 0.12%) to the historical control group (1.11%) in patients who underwent THA or TKA. In patients who underwent primary THA, the SSI rates were lower in the intervention group (2009: 0.36%; 2010: 1.02%; 2011: 0.37%; 2012: 0.48%; 2013: 0.30%, 2014: 0.16%) compared to the historical control group (1.54%). The proportion of S. aureus SSIs was 66.7% in the control group and 33.3% in the intervention group (p-value > 0.05) Sporer, (2016).

 

Grading the evidence

The level of evidence was initially graded as low, because the data used was derived from three observational studies and one quasi-experimental study. Downgrading by at least one level was necessary because of limitations in the study designs: eligibility criteria, (loss to) follow-up and outcome assessment were not always clearly specified. Moreover, most studies did not adjust for confounders. Besides, the indication for screening was not always given in the study protocol, resulting in possible selection bias. Screening also led to a more appropriate antibiotic prophylaxis in the intervention group. In addition, there was inconsistency (probably due to heterogeneity in the protocols), indirectness (some outcomes assessed for patients who underwent total joint arthroplasty instead of THA) and imprecision (fewer outcomes noticed)

 

Category 2 (number of SSIs after screening and application of mupirocin and chlorhexidine to all, compared to application on indication)

 

In the study by Stambough (2016), the amount of SSI was significantly higher in the group of patients who received mupirocin and chlorhexidine on indication (control group) (n =15; 0.8%) compared to the group in which all patients received mupirocin and chlorhexidine (intervention group) (n = 5; 0.2%) in patients who underwent total joint arthroplasty (p-value = 0.013). This difference was also significant in patients who underwent THA (control n = 9 (0.8%); intervention n = 2 (0.2%); p-value = 0.03) Stambough, (2016).

 

Grading the evidence

The quality of evidence was initially graded as low, because the data used was derived from one observational study. Downgrading by at least one level was necessary as there were limitations in the study designs (no adjustments for confounders).

 

Category 3 (number of revisions due to SSIs after screening and application of mupirocin and chlorhexidine on indication, compared to application of chlorhexidine only)

 

The study by Malcolm (2016) indicated no differences in rates of revision arthroplasty between patients who received mupirocin and chlorhexidine on indication (intervention group) (n = 22 (1%)) and patients who received no mupirocin (application of chlorhexidine only) (control group) (n = 25 (1.4%)) (p-value = 0.17). There was a significant difference in the reason for revision. The incidence of revision due to prosthetic joint infection was significantly lower in the intervention group (n = 9 (0.4%)) compared to the control group (n = 16 (0.9%)) (p-value = 0.04). Of the nine patients who underwent revision because of prosthetic joint infections, one person was a carrier of MSSA and eight were non-carriers Malcolm, (2016).

 

Grading the evidence

The evidence was initially graded as low, because the data used was derived from one observational study. Downgrading by at least one level was necessary as there were limitations in the study designs: eligibility criteria, (loss to) follow-up and outcome assessment were not clearly specified. There was also some indirectness, because the outcome was assessed for patients who underwent total joint arthroplasty instead of THA.

Zoeken en selecteren

There was no study available in which the effects of the application of mupirocin and chlorhexidine either to all patients, or to S. aureus carriers only were compared to no application. Therefore, a new question was formulated to investigate the effect of screening and in case positive, application of mupirocin and chlorhexidine, compared to no screening protocol.

 

PICO-1: What are the effects of (S. aureus) screening and application of mupirocin and chlorhexidine, compared to no screening, in patients who underwent total joint arthroplasty?

 

P: (patients) patients who underwent total joint arthroplasty;

I: (intervention) screening and (in case positive for S. aureus) application of mupirocin and chlorhexidine;

C: (comparison) no screening;

O: (outcome) surgical site infection, revision.

 

The working group did not define outcomes a priori, but used definitions as provided in the studies.

 

Search and selection (Methods)

A literature search with relevant search terms was performed in the databases Medline (via OVID) and Embase (via Embase.com) on June 14 2017. The search strategy is provided in the tab “Verantwoording”. The literature search resulted in 138 hits. Studies about the (un)favourable effects of entering a screening protocol and pre-operative decolonisation according to a decolonisation protocol (in case positive for S. aureus application of mupirocin and chlorhexidine), compared to no screening protocol, in patients who underwent total joint arthroplasty were selected. The studies that were found investigated the (un)favourable effects of mupirocin and chlorhexidine within a protocol, in which antibiotic prophylaxis was also given to the patients. Therefore, it is not clear whether the results are solely related to mupirocin and chlorhexidine, or to the adapted systemic prophylaxes in case MRSA was found. The studies show the effects of entering a screening protocol on different outcomes. Based on title and abstract 17 studies were pre-selected. After obtaining full text, eleven studies were excluded, and six studies were included in literature analysis (see exclusion table).

Referenties

  1. Baratz MD, Hallmark R, Odum SM, et al. Twenty Percent of Patients May Remain Colonized With Methicillin-resistant Staphylococcus aureus Despite a Decolonization Protocol in Patients Undergoing Elective Total Joint Arthroplasty. Clin Orthop Relat Res. 2015;473(7):2283-90. doi: 10.1007/s11999-015-4191-3. PubMed PMID: 25690169; PubMed Central PMCID: PMC4457751.
  2. Bratzler DW, Dellinger EP, Olsen KM, et al. American Society of Health-System Pharmacists (ASHP); Infectious Diseases Society of America (IDSA); Surgical Infection Society (SIS); Society for Healthcare Epidemiology of America (SHEA). Clinical practice guidelines for antimicrobial prophylaxis in surgery. Surg Infect (Larchmt). 2013;14(1):73-156. doi: 10.1089/sur.2013.9999. Epub 2013 Mar 5. PubMed PMID: 23461695.
  3. Malcolm TL, Robinson le D, Klika AK, et al. Predictors of Staphylococcus aureus Colonization and Results after Decolonization. Interdiscip Perspect Infect Dis. 2016;2016:4367156. doi:10.1155/2016/4367156. Epub 2016 Jul 26. PubMed PMID: 27528869; PubMed Central PMCID: PMC4977396.
  4. Rao N, Cannella BA, Crossett LS, et al. Preoperative screening/decolonization for Staphylococcus aureus to prevent orthopedic surgical site infection: prospective cohort study with 2-year follow-up. J Arthroplasty. 2011;26(8):1501-7. doi: 10.1016/j.arth.2011.03.014. Epub 2011 Apr 19. PubMed PMID: 21507604.
  5. Schweizer ML, Chiang HY, Septimus E, et al. Association of a bundled intervention with surgical site infections among patients undergoing cardiac, hip, or knee surgery. JAMA. 2015;313(21):2162-71. doi: 10.1001/jama.2015.5387. PubMed PMID: 26034956.
  6. Sporer SM, Rogers T, Abella L. Methicillin-Resistant and Methicillin-Sensitive Staphylococcus aureus Screening and Decolonization to Reduce Surgical Site Infection in Elective Total Joint Arthroplasty. J Arthroplasty. 2016:31(9 Suppl):144-7. doi: 10.1016/j.arth.2016.05.019. Epub 2016 May 18. PubMed PMID: 27387479.
  7. Stambough JB, Nam D, Warren DK, et al. Decreased Hospital Costs and Surgical Site Infection Incidence With a Universal Decolonization Protocol in Primary Total Joint Arthroplasty. J Arthroplasty. 2017;32(3):728-734.e1. doi: 10.1016/j.arth.2016.09.041. Epub 2016 Oct 8. PubMed PMID: 27823845.

Evidence tabellen

Study reference

Study characteristics

Patient characteristics 2

Intervention (I)

Comparison / control (C) 3

 

Follow-up

Outcome measures and effect size 4

Comments

Baratz et al. (2015)

Type of study:
Retrospective clinical study

 

Setting:

Hospital-based

Country:
United States of America (USA)

 

Source of funding:
Not mentioned (only mentioned that the authors or a member of his or her immediate family, has no funding or commercial associations that might pose a conflict of interest in connection with the submitted article)

Inclusion criteria for intervention group:

In this study all patients undergoing primary or revision THA or TKA over a 2-year period at a single institution were included.

Exclusion criteria for intervention group:

Patients were excluded if they had a history of infection at the operative site

Inclusion/exclusion criteria for control group:
Not given

N total at baseline:

Intervention: 3080

Control: 3434

 

Important prognostic factors2:

No baseline values were given

Groups comparable at baseline?

Not possible to assess

Describe intervention (treatment/procedure/test):

Two weeks before the intended surgical date, all patients were screened for nasal colonization with MSSA and MRSA. Microbiologic samples were obtained by trained nurses in the preoperative area using a nasal swab on the inside of the nares for 5 seconds in each naris. Samples were sent for rapid polymerase chain reaction (PCR) using GeneXpert1 XVI (Cepheid, Sunnyvale, CA, USA) for the detection of MRSA. Standard culture was used for the detection of MSSA.

Patients determined to be carriers of either MSSA or MRSA were provided treatment with intranasal 2% mupirocin ointment (Bactroban; GlaxoSmithKline, Middlesex, UK)

twice daily for 5 days and daily skin cleansing with 4% chlorhexidine soap (Dyna-Hex 4; Xttrium Laboratories, Chicago, IL, USA) for 5 days, including the day of surgery. Patients who were colonized received a phone call from a

preoperative nurse and were provided with instructions on the treatment protocol and literature supporting the use of both products. Patients colonized with MRSA at the initial preoperative visit were rescreened on the day of surgery using the identical screening protocol for MRSA. The results of the day-of-surgery rapid PCR were made available before the start of the procedure. Standard perioperative antibiotic prophylaxis was consisted of an intraoperative dose of a first generation cephalosporin (cefazolin) followed by two additional doses postoperatively at 8-hour intervals. Patients with a ß-lactam allergy, patients were treated with an intraoperative dose of vancomycin and one additional dose 12 hours postoperatively. Patients

colonized with MRSA at either the 2-week preoperative screening visit or on the day-of-surgery screening received

a single intraoperative dose of vancomycin in addition to the standard protocol of cefazolin. Patients who remained colonized with MRSA on the day of surgery were placed on isolation precautions during their hospitalization. Patients were monitored prospectively for SSI by a hospital-employed nurse responsible for quality control and infection prevention.

Describe control (treatment/procedure/test):
A patient group from a 2-year period before the implementation of the screening and decolonisation protocol (January 2009 to December 2010).

It is not written what the treatment was of patients in the control group.

 

 

Length of follow-up:

Not given (SSI was defined as a hospital-acquired infection related to a surgical procedure as any infection diagnosed within 1 year of the procedure)

 

Loss-to-follow-up:

Not given

 

Incomplete outcome data:

Unclear

 

 

Outcome measures and effect size (include 95%CI and p-value if available):

2009 to 2010
Primary cases: 2513
Primary infections: 19 (1%)
Revision cases: 567
Revision infections: 14 (3%)

All cases: 3080
All infections: 33 (1%)

2012 to 2013
Primary cases: 2903
Primary infections: 17 (1%)
Revision cases: 531
Revision infections: 10 (2%)
All cases: 3434

All infections: 27 (1%)

Relative risk (95% CI)
Primary cases: 0.77 (0.40 – 1.49)
p-value = 0.51
Revision cases: 0.76 (0.34 – 1.7)
p-value = 0.65
All cases: 0.74 (0.44 - 1.22)
p-value = 0.28


No baseline values were given.

It is not written if patients in the historical control group were treated with antibiotic prophylaxis.

Incomplete outcome data is possible, because how outcome data was measured is not given.

Sporer et al. (2016)

Type of study:
Observational study

 

Setting:

Hospital-based

Country:
United States of America (USA)

 

Source of funding:
Not mentioned (only mentioned that one or more of the authors of this paper have disclosed potential or pertinent conflict of interest, which may include receipt of payment, either direct or indirect, institutional support, or association with an entity in the biomedical field which may be perceived to have potential conflict of interest with this work)

Inclusion criteria intervention group:

All patients who underwent primary THA or TKA between 2009 and 2014 were included in this study.

Exclusion criteria intervention group:

Not mentioned

Inclusion / exclusion criteria control group:
Patients undergoing similar elective joint arthroplasty between January 1, 2008 and December 31, 2008 served as a control population.
N total at baseline:

Intervention: 9825

Control: 1443

 

Important prognostic factors2:

Age (N(%)):
2008
<50 = 119 (8.3)
50 -59 = 376 (26.1)
60 to 69 = 452 (31.4)
70 to 79 = 360 (25.0)

≥ 80 = 133 (9.2)

2009
<50 = 114 (7.5)
50 -59 = 370 (24.3)
60 to 69 = 521 (34.2)
70 to 79 = 354 (23.3)

≥ 80 = 163 (10.7)

2010
<50 = 118 (7.1)
50 -59 = 446 (26.7)
60 to 69 = 568 (34.1)
70 to 79 = 405 (24.3)

≥ 80 = 130 (7.8)

2011
<50 = 94 (6.1)
50 -59 = 374 (24.4)
60 to 69 = 546 (35.6)
70 to 79 = 371 (24.4)

≥ 80 = 145 (9.5)

2012
<50 = 104 (6.1)
50 -59 = 397 (23.3)
60 to 69 = 622 (36.6)
70 to 79 = 416 (24.4)

≥80 = 163 (9.6)

2013
<50 = 86 (5.0)
50 -59 = 405 (23.6)
60 to 69 = 662 (38.6)
70 to 79 = 419 (24.4)

≥80 = 145 (8.4)


2014
 <50 = 101 (6.1)
50 -59 = 369 (22.3)
60 to 69 = 642 (38.8)
70 to 79 = 431 (26.1)

 80 = 110 (6.7)

Sex (male (N(%))
2008 = 593 (41.2)
2009 = 616 (40.5)

2010 = 673 (40.4)
2011 = 606 (39.6)
2012 = 702 (41.3)
2013 = 691 (40.2)
2014 = 684 (41.4)

Length of stay (days) (N (%))
2008
<3 days = 393 (27.3)
3 to 4 days = 930 (64.6)
>5 days = 117 (8.1)

2009
<3 days = 395 (26.0)
3 to 4 days = 1024 (67.3)
>5 days =103 (6.8)

2010
<3 days = 50.8 (30.5)
3 to 4 days = 1076 (64.5)
>5 days = 83 (5.0)

2011
<3 days = 386 (25.2)
3 to 4 days = 1072 (70.1)
>5 days = 72 (4.7)

2012
<3 days = 477 (28.0)
3 to 4 days = 1150 (67.6)
>5 days = 75 (4.4)

2013
<3 days = 526 (30.6)
3 to 4 days = 1123 (65.4)
>5 days = 68 (4.0)

2014
<3 days = 583 (35.3)
3 to 4 days = 994 (60.1)
>5 days = 76 (4.6)

Total
<3 days = 3268 (29.1)
3 to 4 days = 7369 (65.6)
>5 days = 594 (5.3)


Groups comparable at baseline?

Not comparable in age and length of stay

Describe intervention (treatment/procedure/test):

The hospital was started with screening for nasal colonization of MSSA and MRSA before elective surgical procedure in 2009. All surgical patients were instructed to obtain a nasal swab a minimum of 14 days before the planned surgical date. Standard microbiologic culture methods were used to identify MSSA and MRSA strains. Patients who tested positive for Staphylococcus aureus were notified of their results and were instructed to begin 2% mupirocin ointment (Bactroban; GlaxoSMithKline, Middlesex, United Kingdom) applied intranasally along with 2% chlorhexidine gluconate (CHG) showers (HiBiClens is 4%, CHG cloths are 2%; HiBiClens; Monlnlycke Health Care, Norcross, Georgia) 5 days before admission to the hospital. Patients were instructed to apply a pea-sized amount of ointment into each nostril twice daily, morning and evening, along with compressing the nares several times to distribute the ointment. Patients who tested positive for MRSA were treated with vancomycin within 2 hours before surgery. All other Staphylococcus aureus – positive patients were treated with cefazolin within an hour of surgery. Antibiotic prophylaxis was then discontinued with 24 hours after the surgical procedure. In addition, patients who tested positive for MRSA colonization were placed on contact precautions that included the use of barrier gowns and gloves during patient contact. Patients identified as positive for either MSSA or MRSA less than 5 days before admission began CHG showers as soon as possible and continued them until admission. Intranasal decolonisation of these patients identified less than 5 days before surgery continued mupirocin until completion of 10 doses. Patients of unknown colonization status were screened on the day of admission. Mupirocin was administered immediately before surgery in this cohort of patients and was continued postoperatively until the screening results were negative either MSSA or MRSA or the patient completed the 10-dose decolonisation regime. All patients regardless of nasal colonization, were instructed to shower the night before surgery and apply a 6-cloth CHG regimen to all skin, except the face and genitals, a minimum of 1 hour after showering. The topical skin preparation with the chlorhexidine cloths was repeated on the morning of surgery in the holding area immediately before surgery.

Describe control (treatment/procedure/test):
The surgical skin preparation, administration of prophylactic antibiotics, and environmental conditions in the operating room were the same in the intervention and control group.

 

 

Length of follow-up:

Not given (SSIs were determined if a patient’s wound met the criteria of the CDC within 30 days of the index surgical procedure.

 

Loss-to-follow-up:

Not given

 

Incomplete outcome data:

Unclear

 

 

Outcome measures and effect size (include 95%CI and p-value if available):

Primary THA
Infection Rate; %
Change from Previous Year
2008 1.54%
2009 0.36%; -76.91
2010 1.02%; 185.79
2011 0.37%; -63.92
2012 0.48%; 30.0
2013 0.30%; -37.41
2014 0.16%; -45.97

 

Malcolm et al (2016)

Type of study:
Retrospective observational study

 

Setting:

Hospital-based (Cleveland Clinic Foundation main campus. Hillcrest Hospital, Lutheran Hospital, Euclid Hospital)
Country:
United States of America (USA)

 

Source of funding:
Not mentioned

Inclusion criteria:

All patients who underwent primary THA or TKA between October 2011 and March 2014 were included in this study.

Exclusion criteria:

Patients were excluded if they underwent revision TJA.

Inclusion/exclusion criteria control group:
Patients were included in the control group if they did not undergo nasal culture for Staphylococcus aureus at least four days prior to TJA. Patients were excluded if they were found to be

undergoing revision TJA.



N total at baseline:

Intervention: 2291 (56.7%)

Control: 1751 (43.4%)

 

Important prognostic factors2:

Mean age (SD)
Intervention: 63.8 (11.2)
Control: 64.2 (12.0)
p-value = 0.24

Gender, n (%)

Intervention:
Female: 1352 (59%)
Male: 1051 (60%)

Control:
Female: 1051 (60%)
Male: 700 (40%)
 

Groups comparable at baseline?

Not comparable in Charlson Comoribity Index (p-value <0.01

Describe intervention (treatment/procedure/test):

Patients were screened by sampling the nasal flora with

a nasal swab and subsequent analysis with either PCR testing or bacterial cultures up to four weeks before surgery. Approximately

one week prior to surgery, patients who carried S.

aureus were treated with topical mupirocin twice daily for three days. All patients in the study used chlorhexidine body wipes preoperatively and received appropriate perioperative antibiotic prophylaxis. Patients not carrying MRSA received

weight-based intravenous cefazolin 30 to 60 minutes preoperatively followed by repeated postoperative doses every eight hours for 24 hours. Patients who carried MRSA were administered weight-based vancomycin preoperatively followed by repeated postoperative doses every twelve hours for 24 hours. Those allergic to cephalosporin were administered

either clindamycin or vancomycin in a similar manner.

Describe control (treatment/procedure/test):
All patients in the study used chlorhexidine body wipes preoperatively and received appropriate perioperative antibiotic prophylaxis. Patients not carrying MRSA received

weight-based intravenous cefazolin 30 to 60 minutes preoperatively followed by repeated postoperative doses every eight hours for 24 hours. Patients who carried MRSA were administered weight-based vancomycin preoperatively followed by repeated postoperative doses every twelve hours for 24 hours. Those allergic to cephalosporin were administered either clindamycin or vancomycin in a similar manner.

 

 

Length of follow-up:

Not given (at least one year)

 

Loss-to-follow-up:

Not given

 

Incomplete outcome data:

Unclear

 

 

Outcome measures and effect size (include 95%CI and p-value if available):
Total revision:
Intervention group: 22 (1.0%)

Control group: 25 (1.4%)
p-value = 0.17

Reason for revision:

Prosthetic joint infection:
Intervention group: 9 (0.4%)

Control group: 16 (0.9%)
p-value = 0.04

Mechanical failure:
Intervention group: 13 (0.6%)
Control group: 9 (0.5%)
p-value = 1.0

Patients were included in the control group if they did not underwent screening. The reason why they did not underwent screening is not given in the studies.

Rao et al (2011)

Type of study:
Prospective observational study

 

Setting:

Hospital-based

Country:
United States of America (USA)

 

Source of funding:
Not funded

Inclusion criteria:

Not given (Its only written that patients in the intervention and preintervention control group were treated by the same surgeons. All patients who were treated by the other surgeons were included in the concurrent control group. In addition, all 741 patients whose surgery was performed by the 3 participating surgeons between October 2004 and October 2005 served as a preintervention control group)

Exclusion criteria:

Not given

N total at baseline:

Intervention group: 1440
Concurrent control group: 2284
Preintervention control group: 741

 

Important prognostic factors2:

No baseline values given

Groups comparable at baseline?

Not possible to assess

Describe intervention (treatment/procedure/test):

Patients were screened for S aureus nasal carriage two to four weeks before surgery.

Patients were educated

about the rationale for nasal cultures, and informed

consent was obtained. Samples were collected from both nares on a single swab (BBL Culture Swab Plus; BD

Diagnostics, Sparks, MD). The inside circumference of each anterior nares was rubbed for 3 to 5 seconds to

obtain adequate sampling. Specimens were inoculated

onto BBL CHROMagar MRSA and CHROMagar SA plates (BD Microbiology Systems, Sparks, MD), which were incubated for 20 to 28 hours at 35°C to 37°C. After 24 hours, we interpreted mauve colonies present on both

plates as MRSA and on only the CHROMagar SA plate as

MSSA. Negative plates were incubated for an additional

24 hours. Mauve colonies present on either medium at

48 hours were verified as S aureus by Gram stain and

coagulase testing (Staphaurex; Remel, Lenexa, KS). Mauve colonies growing on both media were reported

as MRSA, whereas colonies growing only on CHROMagar

SA were reported as MSSA. Approximately 1 week before surgery, patients with nasal cultures positive for S aureus were educated about the rationale for the decolonisation protocol, which was

performed in the outpatient setting. Patients were

instructed to apply mupirocin nasal ointment twice

daily to both nares and to bathe with chlorhexidine daily for 5 days immediately before the scheduled surgery.

During surgery, all patients received perioperative antibiotic prophylaxis. The standard regimen was cefazolin

2 g administered 30 to 60 minutes before surgery

followed by 1 g every 8 hours for 24 hours. The alternative regimen for patients with a history of MRSA infection or type I allergy to penicillin and for MRSA carriers in the intervention group was vancomycin 1 g 60

minutes before surgery followed by 1 g every 12 hours for 24 hours.

Describe control (treatment/procedure/test):
It is not written what the treatment was of patients in the control group.

 

 

 

Length of follow-up:

Two years

 

Loss-to-follow-up:

The study mentioned no lost to follow-up, but 155 patients in the intervention group missed screening.

 

Incomplete outcome data:

Unclear

 

 

Outcome measures and effect size (include 95%CI and p-value if available):

No. of SSIs in patients with positive nasal cultures confirmed (intervention group) and in the concurrent control group
Intervention = 0
Concurrent control = 19

Surgical Site Infections among patients who underwent TJA by the same group of orthopaedic surgeons during the preintervention period and intervention period:
MSSA = 3
MRSA = 2
Others = 6
Preintervention period:
MSSA = 3
MRSA = 8
Others = 9

Type of infection (type intervention / n preintervention period or intervention period):

Preintervention period:
Risk of superficial infections 11/741 (1.5%)
Risk of deep infections:
9/741 (1.2%)
Total:
20/741 (2.7%)

Intervention period:
Risk of superficial infections: 9/1440 (0.6%)
Risk of deep infections:
8/1440 (0.6%)
Total:
20/741 (2.7%)

It is written that all patients were prospectively monitored for development of SSIs.

Schweizer et al. (2016)

Type of study:
A quasi-experimental study

 

Setting:

Hospital-based

Country:
United States of America (USA)

 

Source of funding:
This project was funded by the

Agency for Healthcare Research and Quality

(AHRQ; HHSA2902006100021I and grant

HS022467-02), US Department of Health and

Human Services. It also received support from the

VA Health Services Research and Development

(CDA 11-211; Dr Schweizer).

Inclusion criteria intervention group:

Eligible patients were 18 years or older and underwent scheduled, urgent, or emergent primary hip or knee

arthroplasty (ie, replacement or resurfacing).


Exclusion criteria intervention group:

Arthroplasty revisions, cardiac transplants,

transapical valve implantation, and operations performed

using percutaneous or thoracotomy approaches were

not eligible for this study. We excluded operations among patients

with pre-existing infections at the surgical site.

Inclusion/exclusion criteria control group:

Only mentioned that hospitals

using some, but not all, bundle elements during the preintervention

period could participate.

N total at baseline:

Intervention group: 20642 operations
Control group: 11059 operations

 

Important prognostic factors2:

Sex:
Preintervention group:
Female: 12661 (61.4)
Intervention group:
Female: 6734 (60.9)
p-value = 0.41

Age, median (range)
Preintervention group: 68 (21 to 107)
Intervention group: 68 (18 to 101)
p-value <0.001
 
Groups comparable at baseline?

Not comparable in age, CCI and MRSA history

Describe intervention (treatment/procedure/test):

Hospital staff swabbed patients’ nares during scheduled preoperative

clinic visits (usually 10 to 14 days, but no more than 30

days before the operations). Each laboratory used their standard tests (eg, polymerase chain reaction, culture on chromogenic

agar, standard bacterial culture) to determine MRSA and MSSA carrier status. The most common tests were chromogenic agar for MRSA and standard culture for MSSA. Patients with positive screening tests for either MRSA or MSSA applied

mupirocin intranasally twice daily and bathed with CHG

once daily for up to 5 days immediately before their operations. Patients that received fewer than 10 doses of mupirocin before their operations received the remaining doses during

the postoperative period. The CHG bathing was not

continued after the operation. Patients with negative MRSA and

MSSA nasal screens bathed with CHG the night before and the morning of their operations. Perioperative prophylaxis was administered using weight based

dosing and redosing according to the 2013 American Society

of Health-System Pharmacists (ASHP) guidelines. The

antimicrobial agents used for perioperative prophylaxis varied by the patients’ S aureus carrier status; noncarriers and MSSA carriers received either cefazolin or cefuroxime for perioperative prophylaxis, whereas MRSA carriers received both cefazolin or cefuroxime and vancomycin. If a patient had a confirmed

β-lactam allergy, surgeons were encouraged to provide

perioperative prophylaxis with vancomycin rather than

cefazolin or cefuroxime and to add either gentamicin or aztreonam for gram-negative coverage. Patients with negative screening tests but with documented histories of MRSA carriage or infection were treated as carriers. Patients who were either not screened because they had emergent operations or

whose screening results were not known at the time of their operations received vancomycin and cefazolin or cefuroxime for perioperative prophylaxis. In these situations, nasal swabs

were obtained for MSSA and MRSA screening and patients began the decolonisation regimen immediately before their operations. Mupirocin was continued until screening test results were

known; mupirocin was discontinued if test results

were negative.

Describe control (treatment/procedure/test):
The preintervention period extended from March 1, 2009, to the date on which a hospital began the intervention.

 

 

 

Length of follow-up:

Patients were followed up for 90 days after their operations by

infection preventionists at participating hospitals.


Loss-to-follow-up
:

Not given

 

Incomplete outcome data:

Unclear

 

 

Outcome measures and effect size (include 95%CI and p-value if available):


Complex Staphylococcus aureus Surgical Site Infections per 10000 operations

Rate ratio for Bundled Intervention (95% CI) (intervention period vs preintervention period)

Hip or knee arthroplasties
RR 0.48 (95%CI 0.29 – 0.80)
p-value = 0.005

Urgent/emergent
RR 0l.44 (0.07 – 2.72)
p-value = 0.38

Scheduled
RR 0.51 (0.30 – 0.85)
p-value = 0.009

Hospitals that using some, but not all bundle elements during the preintervention period could participate.


Its not mentioned in the study how patients were followed up by infection preventionists.

Stambough et al. (2016)

Type of study:
Retrospective review of prospective data

Setting:

Hospital-based

Country:
United States of America (USA)

 

Source of funding:
Its mentioned in the article that one or more of the authors of this paper have disclosed potential or pertinent conflicts of interest, which may include receipt of payment, either direct or indirect, institutional support, or association with an entity in the biomedical field which may be perceived to have potential conflict of interests with this work.

Inclusion criteria:

Cohort of patients from the academic medical center’s infection surveillance program who underwent elective primary hip or knee arthroplasty between March 1, 2011 and July 31, 2015. Patients were divided in 2 cohorts based on the 25 months before (control group) and the 25 months after establishment of the universal decolonisation protocol (intervention group).

Exclusion criteria:

Patients were excluded when they were admitted via the emergency department. Patients with prior instrumentation who were undergoing revision or conversion arthroplasty were also excluded.
Patients treated in the 3 months surrounding the protocol change were removed to control for potential treatment bias during the transition period.

N total at baseline (n= 4186 replacements):

Intervention group (2205 TJA in 2049 patients):
TKA: 1003
THA: 1202

Control group (1981 TJA in 1846 patients):
TKA: 836
THA: 1145

Important prognostic factors2
:

Age (y mean±SD):
Control group: 57.2±14.1
Intervention group: 58.2±13.5
2 = 0.08)
 
Gender (n male):
Control group: 548
Intervention group: 558
2 = 0.025)

Groups comparable at baseline?

Yes (only not in ASA)

Describe intervention (treatment/procedure/test):

Patients in the intervention group were screened within 30 days of their surgery. Swabs of both nares were obtained and sent to the laboratory. All patients were treated with 2% nasal ointment and a single preoperative chlorhexidine shower. At the day of surgery, all nasal screening results were available. Carriers of MRSA were perioperative treated with Vancomycin 1 gram every 12 hours starting at least 30 minutes before incision and lasting for 24 hours. The surgical technique, implants and postoperative care were similar in both groups. In addition to preoperative mupirocin nasal ointment and chlorhexidine scrub, all patients were administered IV antibiotics within 1 our before surgical incision. Antibiotic selection was based on a risk stratification protocol and was continued for 24 hours postoperatively. The majority of patients received a weight-based dose of IV cefazolin – 2g for those with a weight <120 kg and 3 g if >120 kg. Those with a true penicillin allergy were given 1 g of vancomycin and 1 g of IV aztreonam to cover both gram-positive and gram-negative microbes. Additionally, patients who resided in a nursing facility, were on dialysis, had been hospitalized within the past year, or had a documented history of MRSA infection from an unrelated previous admission were administered IV vancomycin in addition to weight-based cefazolin.

Describe control (treatment/procedure/test):
Patients in the control group were all screened for S aureus colonization and selectively treated preoperatively with 5 days mupirocin. Patients were treated with a CHG wipes at the day of surgery.

Length to follow-up:
90 days

Loss-to-follow-up:
Not given

Incomplete outcome data:

Unclear

Outcome measures and effect size (include 95%CI and p-value if available):
Total number of SSI infections (THA+TKA):
Control group: 15 (0,8%)
Intervention group: 5 (0,2%)
(P-value = 0.013)

Infection caused by MRSA or MSSA (THA+TKA):
Control group: 10 (0.5%)
Intervention group: 2 (0.09%)
(P-value = 0.01)

Infection caused by MRSA (THA+TKA):
Control group: 6 (0.3%)
Intervention group: 1 (0.04%)
(P-value = 0.05)

Total number of SSI infections (THA):
Control group: 9
Intervention group: 2
(P-value = 0.03)

Infection caused by MRSA or MSSA (THA):
Control group: 7
Intervention group: 0
(P-value = 0.003)

Infection caused by MRSA (THA):
Control group: 4
Intervention group: 0
(P-value = 0.05)

 

 

Notes:

  1. Prognostic balance between treatment groups is usually guaranteed in randomized studies, but non-randomized (observational) studies require matching of patients between treatment groups (case-control studies) or multivariate adjustment for prognostic factors (confounders) (cohort studies); the evidence table should contain sufficient details on these procedures.
  2. Provide data per treatment group on the most important prognostic factors ((potential) confounders).
  3. For case-control studies, provide sufficient detail on the procedure used to match cases and controls.
  4. For cohort studies, provide sufficient detail on the (multivariate) analyses used to adjust for (potential) confounders.

 

Risk of bias table for intervention studies (observational: non-randomized clinical trials, cohort and case-control studies)

Study reference

 

 

 

(first author, year of publication)

Bias due to a non-representative or ill-defined sample of patients?1

 

 

 

(unlikely/likely/unclear)

Bias due to insufficiently long, or incomplete follow-up, or differences in follow-up between treatment groups?2

 

 

(unlikely/likely/unclear)

Bias due to ill-defined or inadequately measured outcome ?3

 

 

(unlikely/likely/unclear)

Bias due to inadequate adjustment for all important prognostic factors?4

 

 

 

(unlikely/likely/unclear)

Baratz et al. (2015)

Unclear

Unclear

Unclear

Likely

Sporer et al. (2016)

Unclear

Unclear

Unclear

Likely

Malcolm et al. (2016)

Unclear

Unclear

Unclear

Likely

Rao et al. (2011)

Unclear

Likely

Unclear

Likely

Schweizer et al. (2016)

Unclear

Unclear

Unclear

Unlikely

Stambough et al. (2016)

Unlikely

Unclear

Unclear

Likely

  1. Failure to develop and apply appropriate eligibility criteria: a) case-control study: under- or over-matching in case-control studies; b) cohort study: selection of exposed and unexposed from different populations.
  2. 2 Bias is likely if: the percentage of patients lost to follow-up is large; or differs between treatment groups; or the reasons for loss to follow-up differ between treatment groups; or length of follow-up differs between treatment groups or is too short. The risk of bias is unclear if: the number of patients lost to follow-up; or the reasons why, are not reported.
  3. Flawed measurement, or differences in measurement of outcome in treatment and control group; bias may also result from a lack of blinding of those assessing outcomes (detection or information bias). If a study has hard (objective) outcome measures, like death, blinding of outcome assessment is not necessary. If a study has “soft” (subjective) outcome measures, like the assessment of an X-ray, blinding of outcome assessment is necessary.
  4. Failure to adequately measure all known prognostic factors and/or failure to adequately adjust for these factors in multivariate statistical analysis.

Overwegingen

There is a minimal reduction of SSI by prophylactic use of mupirocin/chlorhexidine in all patients compared to selective use; selective use shows minimally reduced SSI compared to no use. The level of evidence for this reduction in SSI is very low grade because it is based on only a few cohort studies without any randomised controlled trials. The overall infection percentages of any regimen reports are well below 2%, so potential benefits are marginal at best.

 

It is questionable whether the study results mentioned can be extrapolated to the Netherlands since they are performed in countries with a much higher MRSA prevalence and the results may differ from our situation.

 

Furthermore, the studies performed are of heterogeneous nature regarding inclusion criteria and outcome reporting. In the studies it is not clearly stated what the procedures were for screening carriership and what the exact regimens of decolonisation were.

 

Another weakness is that it is unclear what the adherence to treatment was of all patients. Also in many studies, as a consequence of the screening for MRSA/MSSA, patients in the intervention group received a more adequate antibiotic prophylaxis (vancomycin in case of MRSA carriage), whilst in the control group, this carriage was unknown. In joint arthroplasty surgery other micro-organisms, like Coagulase Negative Staphylococci are also known to be important causes of implant infections.

 

With the current limited data it is impossible to calculate exactly the cost effectiveness of any approach. The costs of logistics, mupirocin, chlorhexidine, screening by PCR, costs of infection treatment and loss of labour participation are all involved, as well as the burden to the patients of infection treatment. Standard application to all patients undergoing THA may result in increased mupirocin resistance and unnecessary costs; screening patients may be beneficial in reducing resistance, but has its costs and logistical burden too.

 

In conclusion, based on the literature there is insufficient evidence to support the SWAB guideline regarding screening and decolonization of S. aureus with mupirocin and chlorhexidine in patients undergoing total hip arthroplasty.

Autorisatiedatum en geldigheid

Laatst beoordeeld : 12-02-2019

Laatst geautoriseerd : 12-02-2019

Module

Party in control

Year of authorization

Next assessment of actuality

Frequency of assessment actuality

Which party/parties monitors actuality

Important factors that might lead to change in recommendations

Pre-operative decolonisation

NOV, NVMM

2018

2021

Every three years

NOV, NVMM

New literature available

Initiatief en autorisatie

Initiatief : Nederlandse Orthopaedische Vereniging

Geautoriseerd door:
  • Koninklijk Nederlands Genootschap voor Fysiotherapie
  • Nederlandse Orthopaedische Vereniging
  • Nederlandse Vereniging voor Klinische Geriatrie
  • Nederlandse Vereniging voor Medische microbiologie

Algemene gegevens

The development of this guideline was funded by the Stichting Kwaliteitsgelden Medisch Specialisten (SKMS; Foundation for Quality Funding for Medical Specialists).

Doel en doelgroep

Aim of the guideline

The main purpose of the guideline is to provide the best possible care to patients with osteoarthritis of the hip, by informing optimal treatment decisions and reducing unwarranted variation in the delivery of care and long-term failure of the implants.

 

Envisaged users of the guideline

This guideline was developed for all Dutch healthcare providers of patients with osteoarthritis of the hip.

Samenstelling werkgroep

This guideline was developed and sponsored by the Netherlands Orthopaedic Association (NOV), using government funding from the Quality Funding for Medical Specialists (Stichting Kwaliteitsgelden Medisch Specialisten in the Netherlands, SKMS). Patient participation was cofinanced by the Quality Funding Patient Consumers (Stichting Kwaliteitsgelden Patiënten Consumenten, SKPC) within the program ‘Quality, insight and efficiency in medical specialist care’ (Kwaliteit, Inzicht en Doelmatigheid in de medisch specialistische Zorg, KIDZ). The early preparative phase started in October 2016. The guideline was officially authorised by the Netherlands Orthopaedic Association on February 12, 2019. Decisions were made by consensus. At the start of guideline development, all working group members completed conflict of interest forms.

 

Members of the guideline development working group

  • Dr. B.A. Swierstra, orthopaedic surgeon, Sint Maartenskliniek, Nijmegen, NOV, Chair
  • Dr. R.H.M. ten Broeke, orthopaedic surgeon, Maastricht University Medical Centre, NOV
  • Drs. P.D. Croughs, medical microbiologist, Erasmus University Medical Center, NVMM
  • Dr. R.A. Faaij, geriatrician, Diakonessen Hospital, Utrecht, NVKG
  • Dr. P.C. Jutte, orthopaedic surgeon, University Medical Center Groningen, NOV
  • D.E. Lopuhaä, policy worker patient advocacy, Dutch Arthritis Society
  • Dr. W.F.H. Peter, physiotherapist, Leiden University Medical Center, KNGF
  • Dr. B.W. Schreurs, orthopaedic surgeon, Radboud University Medical Centre, Nijmegen, NOV
  • Dr. S.B.W. Vehmeijer, orthopaedic surgeon, Reinier de Graaf Hospital, Delft, NOV
  • Dr. A.M.J.S. Vervest, orthopaedic surgeon, Tergooi Hospital, Hilversum, NOV
  • J. Vooijs†, patient with osteoarthritis, National Association ReumaZorg Nederland
  • Drs. G. Willemsen-de Mey, chairperson, National Association ReumaZorg Nederland

 

Readers:

  • S. Nijssen, medical microbiologist, VieCuri Medical Center, Venlo, NVMM
  • R.J. Rentenaar, medical microbiologist, University Medical Center, Utrecht, NVMM
  • Dr. A.T. Bernards, medical microbiologist, Leiden University Medical Center, NVMM

 

With the help of:

  • Dr. M.A. Pols, senior advisor, Knowledge Institute of the Dutch Association of Medical Specialists
  • Dr. M.L. Molag, advisor, Knowledge Institute of the Dutch Association of Medical Specialists
  • A.L.J. Kortlever- van der Spek, junior advisor, Knowledge Institute of the Dutch Association of Medical Specialists
  • M.E. Wessels MSc, clinical librarian, Knowledge Institute of the Dutch Association of Medical Specialists

Belangenverklaringen

At the start of the project, the members of the working group have declared in writing if, in the last five years, they have held a financially supported position with commercial businesses, organisations or institutions that may have a connection with the subject of the guidelines. Enquiries have also been made into personal financial interests, interests pertaining to personal relationships, interests pertaining to reputation management, interests pertaining to externally financed research, and interests pertaining to valorisation of knowledge. These declarations of interest can be requested from the secretariat of the Knowledge Institute of the Dutch Association of Medical Specialists. See below for an overview.

 

Werkgroeplid

Mogelijke conflicterende belangen met betrekking tot deelname werkgroep

Toelichting

Dr. B.W. Schreurs

Presentaties voor Stryker over de Exeter totale heupprothese (educational fee naar afdeling)

Doet reviews voor DEKRA KEMA (betaald)

Voorzitter European Hip Society (onbetaald)

Voorzitter wetenschappelijke adviesraad LROI (onbetaald)

Voorzitter adviesraad botbank Sanquin (onbetaald)

Lid Commissie Orthopedisch Implantaten Classificatie NOV (onbetaald)

 

Dr. P.C. Jutte

Hoofdonderzoeker LEAK-studie (ZonMW)

Voorzitter werkgroep weke delen en bottumoren

Lid werkgroep orthopedische infecties NOV

Lid werkgroep bottumoren NOV

Lid commissie beentumoren Nederland

Lid onderwijscommissie NOV

Lid medische adviesraad patientvereniging Sarcoma NL

 

D.E. Lopuhaä

Geen belangen

 

Dr. R.H.M. ten Broeke

Voorzitter werkgroep "Heup" (Dutch Hip Society) NOV sinds 2015 (onbetaald)

Daarvoor gedurende 3 jaar reeds bestuurslid van deze werkgroep (onbetaald)

Klinisch onderzoek gefinancierd door firma Stryker (RSA en PET-CT-onderzoek bij vergelijking van 2 ongecementeerde cupdesigns) (onbetaald)

 

Dr. W.F.H. Peter

Geen belangen

 

Dr. P.D. Croughs

Geen belangen

 

Dr. S.B.W. Vehmeijer

Directeur Orthoparc (onbetaald)

Bestuurslid Dutch Hip Society (onbetaald)

National Representative European Hip Society (onbetaald)

Consulent Zimmer Biomet (betaald)

 

Dr. B.A. Swierstra

Voorzitter Stichting OrthoResearch (onbetaald)

Advisory Board Arthroplasty Watch (onbetaald)

Lid Wetenschappelijke Advies Raad Landelijke Registratie Orthopaedische Implantaten (onbetaald)

Board of Directors International Society of Orthopaedic Centers (onbetaald)

Coeditor Acta Orthopaedica (onkostenvergoeding)

 

Dr. R.A. Faaij

Geen belangen

 

Dr. A.M.J.S. Vervest

Lid-beroepsgenoot Regionaal Tuchtcollege voor de Gezondheidszorg Den Haag (betaald)

Voorzitter Centrale Opleidings Commissie Tergooi (onbetaald)

 

J. Vooijs

Geen belangen

 

Drs. G. Willemsen – de Mey

Geen belangen

 

Meelezers

Drs. S. Nijssen

ISO 15189 auditor, betaald door RvA

 

Dr. R.J. Rentenaar

Commissie bacteriologie Stichting Kwaliteitsbewaking Medische Laboratoria (SKML) (tegen onkostenvergoeding).

Verschillende producenten stellen soms kleine hoeveelheden van producten ter beschikking kosteloos of tegen gereduceerd tarief t.b.v. verificatie doeleinden

 

Dr. A.T. Bernards

Geen belangen

 

Inbreng patiëntenperspectief

Attention was paid to the patients’ perspective by participation in the working group of the Dutch Arthritis Society and National Association ReumaZorg Nederland. In addition, the Patients Federation Netherlands assessed the draft guideline during the consultation phase and made suggestions for improvement of the guideline.

Methode ontwikkeling

Evidence based

Implementatie

Recommendation

Time needed for implementation:
<1 year,

1 to 3 years or

>3 years

Expected effects on costs

Conditions for implementation

Possible barriers to implementation1

Actions for implementation2

Reponsibility for these actions3

Other remarks

All

<1 year

Increase

n.a.

Availabillty of mupirocin and chlorhexidine

Quality audit

NOV

n.a.

Werkwijze

The guideline was developed in agreement with the criteria set by the advisory committee on guideline development of the Dutch Association of Medical Specialists (Medisch Specialistische Richtlijnen 2.0; OMS 2011), which are based on the AGREE II instrument (Brouwers (2010); www.agreetrust.org). The guideline was developed using an evidence-based approach endorsing GRADE methodology, and meeting all criteria of AGREE-II. Grading of Recommendations Assessment, Development and Evaluation (GRADE) is a systematic approach for synthesising evidence and grading of recommendations offering transparency at each stage of the guideline development (Guyatt, 2011; Schünemann, 2013).

 

The guideline development process involves a number of phases: a preparatory phase, development phase, commentary phase, and authorisation phase. After authorisation, the guideline has to be disseminated and implemented and its uptake and use have to be evaluated. Finally, the guideline has to be kept up-to-date. Each phase involves a number of practical steps Schünemann, (2014).

 

As a first step in the early preparatory phase, a broad forum discussion was held and all relevant stakeholders were consulted to define and prioritise the key issues the recommendations should address. Subsequently, the methodologist together with the chairman of the working group created a draft list of key issues, which was extensively discussed in the working group.

 

Despite aiming for an update of the guideline from 2010, due to financial constraints not all clinical questions from the former edition could be updated, so it was decided to perform a so-called modular update. Selecting modules with a higher priority for update formed part of this discussion and selection process. This resulted in the following approach.

 

Modules that were updated:

  • Indications for primary total hip arthroplasty.
  • Type of bearing (part of the module surgical techniques).
  • Diameter of the head (part of the module surgical techniques).
  • Surgical approach (part of the module surgical techniques).
  • Systemic antibiotics (part of the module perioperative care in primary total hip arthroplasty).
  • Antibiotic-impregnated bone cement (part of the module perioperative care in primary total hip arthroplasty).
  • Preoperative decolonisation (part of the module perioperative care in primary total hip arthroplasty).
  • Routine follow-up (part of the module postoperative care).

 

Modules considered still valid:

  • cemented versus uncemented hip prosthesis (part of the module surgical techniques in primary total hip arthroplasty).

 

Modules removed from the guideline:

  • Resurfacing hip prosthesis (part of the module surgical techniques in primary total hip arthroplasty).
  • Minimally invasive surgery (part of the module surgical techniques in primary total hip arthroplasty).
  • Guidelines for MRSA carriers (part of the module perioperative care in primary total hip arthroplasty).

 

Modules that were replaced by a reference to related guidelines:

  • Hematogenous infection (part of the module postoperative care).
  • Prevention of thrombo-embolic complications (part of the module perioperative care in primary total hip arthroplasty).
  • Physcial therapy (part of the module perioperative care in primary total hip arthroplasty).

 

Modules not updated because guidelines are expected soon:

  • Anaesthesiological technique (part of the module perioperative care in primary total hip arthroplasty).

 

Modules that were added:

  • Patient Reported Outcome Measures.
  • Place and organisation of fasttrack.
  • Organization of care for frail elderly.

 

The selected (high priority) issues were translated into carefully formulated clinical questions, defining patient/problem, intervention, and prioritising the outcomes relevant for decision-making.

 

The literature was systematically searched using the databases MEDLINE (Ovid), Embase and the Cochrane Database of Systematic Reviews. Selection of the relevant literature was based on predefined inclusion and exclusion criteria and was carried out by a member of the working group in collaboration with the methodologist. For each of the clinical questions, the evidence was summarised by the guideline methodologist using the GRADE approach: a systematic review was performed for each of the relevant outcomes and the quality of evidence was assessed in one of four grades (high, moderate, low, very low) by analysing limitations in study design or execution (risk of bias), inconsistency of results, indirectness of evidence, imprecision, and publication bias. The evidence synthesis was complemented by a working group member considering any additional arguments relevant to the clinical question. Evidence synthesis, complementary arguments, and draft recommendations were extensively discussed in the working group and final recommendations were formulated. Final recommendations are based on the balance of desirable and undesirable outcomes, the quality of the body of evidence across all relevant outcomes, values and preferences, and (if relevant) resource use. The strength of a recommendation reflects the extent to which the guideline panel was confident that desirable effects of the intervention outweigh undesirable effects, or vice versa, across the range of patients for whom the recommendation is intended. The strength of a recommendation is determined by weighting all relevant arguments together, the weight of the body of evidence from the systematic literature analysis, as well as the weight of all complementary arguments. Guideline panels must use judgment in integrating these factors to make a strong or weak recommendation. Thus, a low quality of the body of evidence from the systematic literature analysis does not exclude a strong recommendation, and weak recommendations may follow from high quality evidence Schünemann, (2013).

 

After reaching consensus in the working group, the draft guideline was subjected to peer review by all relevant stakeholders. Amendments were made and agreed upon by the working group, and the final text was presented to the Netherlands Orthopaedic Association (NOV), the Royal Dutch Society for Physical Therapy (KNGF), the Dutch Society of Medical Microbiology (NVMM) and the Dutch Geriatrics Society (NVKG) for formal authorisation and to the National Association ReumaZorg Nederland and the Dutch Arthritis Society for approval. The final guideline was approved by the National Association ReumaZorg Nederland and the Dutch Arthritis Society, and was officially authorised by the Netherlands Orthopaedic Association, the Royal Dutch Society for Physical Therapy, the Dutch Society of Medical Microbiology and the Dutch Geriatrics Society. The guideline was published and is freely accessible in the Dutch guideline database (Richtlijnendatabase, www.richtlijnendatabase.nl). The Dutch guideline database has a modular structure, with each clinical question as a separate entry, thus allowing for modular updates.

 

References

Brouwers M, Kho ME, Browman GP, et al. AGREE II: Advancing guideline development, reporting and evaluation in healthcare. Can Med Assoc J. Dec;182:E839-842; doi: 10.1503/cmaj.090449.

Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. Journal of Clinical Epidemiology. 2011;64 383–394. (doi:10.1016/j.jclinepi.2010. 04.026).

Schünemann H, Brożek J, Guyatt G, et al. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available from www.guidelinedevelopment.org/ handbook.

Schünemann HJ, Wiercioch W, Etxeandia I, et al. Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise. CMAJ. 2014;186(3):E123-42. doi: 10.1503/cmaj.131237. Epub 2013 Dec 16. PubMed PMID: 24344144.

OMS, Orde van Medisch Specialisten. Eindrapport Medisch Specialistische Richtlijnen 2.0. Available from: https://www.demedischspecialist.nl/onderwerp/raad-kwaliteit. 2011.

Zoekverantwoording

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